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Number: 037
Subject: Bone and Tendon Graft Substitutes and Adjuncts
Reviewed: August 12, 2013
Important note
This Clinical Policy Bulletin expresses our determination of whether certain services or supplies are medically necessary. We reached these conclusions based on a review of currently available clinical information including:
We expressly reserve the right to revise these conclusions as clinical information changes, and welcome further relevant information.
Each benefits plan defines which services are covered, excluded and subject to dollar caps or other limits. Members and their dentists will need to consult the member's benefits plan to determine if any exclusions or other benefits limitations apply to this service or supply. The conclusion that a particular service or supply is medically necessary does not guarantee that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that we consider medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members.
Aetna considers the OP-1 Implant experimental and investigational for all indications other than those listed above because its effectiveness for indications other than the ones listed above has not been established.
Use of autograft or cadaveric allograft is unfeasible for one of more of the reasons listed in Section I above
The INFUSE Bone Graft is considered medically necessary for treating skeletally mature persons with acute, open tibial shaft fractures that have been stabilized with intramedullary nail fixation after appropriate wound management, when INFUSE Bone Graft is applied within 14 days after the initial fracture.
Aetna considers the INFUSE Bone Graft experimental and investigational for all other indications, including its use in multiple levels because its effectiveness for indications other than the ones listed above has not been established.
Note: The INFUSE Bone Graft is also known as bone morphogenic, or morphogenetic protein-2, BMP-2.
Aetna considers the Pro Osteon Porous Hydroxyapatite Bone Graft Substitute experimental and investigational for repair of metaphyseal fracture defects or repair of long bone cyst and tumor defects, because it has not been shown to be more effective than autograft or cadaveric allograft for these indications.
Aetna considers the Pro Osteon Bone Graft Substitute experimental and investigational for use in spinal fusion, epiphyseal fractures or other indications because its effectiveness for these indications has not been established.
Aetna considers the use of platelet-rich plasma, alone or in conjunction with bone grafting materials, experimental and investigational for augmentation procedures (e.g., for dental implants and for the floor of the maxillary sinus) or indications (e.g., soft tissue injuries) other than thrombocytopenia because its effectiveness has not been established.
See also CPB 0244 - Wound Care (stating that autologous platelet-rich plasma, autologous platelet gel, and autologous platelet-derived growth factors (e.g., Procuren) are considered experimental and investigational for chronic wound healing).
Aetna considers a surgical mesh composed of porcine intestinal submucosa experimental and investigational because its clinical value in rotator cuff repair surgery, repair of anorectal fistula, and for other indications has not been established.
Aetna considers bone void fillers experimental and investigational for the treatment of delayed unions, nonunions and spinal fusion because they have not been proven effective for these indications.
Note: Bone void fillers (e.g., Allomatrix putty, Integra Mozaik Osteoconductive Scaffold putty, Opteform, a demineralized bone matrix-based allograft and Vitoss bioactive bone graft) are most commonly used in orthopedic surgery for filling osteochondral defects; their use as such is considered a medically necessary part of the surgical procedure.
Aetna considers PMMA antibiotic beads medically necessary for use in conjunction with intravenous antibiotics in the treatment of chronic osteomyelitis.
Aetna considers the use of mesenchymal stem cell therapy (e.g., Osteocel, Osteocel Plus, Ovation, Regenexx, and Trinity Evolution) experimental and investigational for all orthopedic applications including repair or regeneration of musculoskeletal tissue, spinal fusion, and long bone nonunions because there is insufficient evidence to support its use for these indications, especially its safety and long-term outcomes.
Aetna considers bone marrow injections medically necessary in the treatment of bone cysts (unicameral/simple).Aetna considers the use of bone marrow aspirate experimental and investigational for all other orthopedic applications including nonunion fracture, repair or regeneration of musculoskeletal tissue,osteoarthritis and as an adjunct to spinal fusion because there is insufficient evidence to support its use for these indications.
See also CPB 0743 - Spinal Surgery: Laminectomy and Fusion.
Osteogenic proteins, also referred to as bone morphogenetic, or morphogenic proteins (BMPs), are a family of bone-matrix polypeptides isolated from a variety of mammalian species. Implantation of OPs induces a sequence of cellular events that lead to the formation of new bone. Some of the potential clinical applications of OPs are: (i) as a bone graft substitute to promote spinal fusion and to aid in the incorporation of metal implants, (ii) to improve the performance of autograft and allograft bone, and (iii) as an agent for osteochondral defects.
Recombinantly produced human osteogenic protein-1 (OP-1), also known as BMP-7, was developed by Stryker Biotech (Hopkinton, MA), a division of Stryker Corporation. The OP-1 Implant was approved by the Food and Drug Administration (FDA) as a Humanitarian Use Device (HUD). As defined in the Federal Food, Drug and Cosmetic Act (21 CFR 814.124), a HUD "is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year." The FDA developed the HUD categorization to provide an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting small patient populations.
The manufacturer submitted to the FDA results from a multi-center Long Bone Treatment Study, where 10 patients with long bone nonunions having prior failed autograft were treated with OP-1 implant. Seven of the 10 patients had clinical healing (pain and function), and 2 of 10 had radiographic healing (bridging in 3 or 4 cortices).
The manufacturer also submitted the results of the multi-center Tibial Nonunion Study, where a subset of 14 patients with prior failed autograft was treated with the OP-1 Implant, and 13 patients were treated with autograft. Twelve of patients receiving the OP-1 Implant had clinical resolution (pain and function) of their nonunion, and 8 patients had radiographic healing (bridging in three views). By comparison, 12 of 13 patients receiving autograft had clinical resolution of their nonunion, and 12 of 13 had radiographic healing. The FDA concluded that, although the OP-1 implant was an effective treatment for nonunions, the implant was not as effective as autograft. Therefore, the FDA product labeling states that the OP-1 bone morphogenic protein is indicated "for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed" (emphasis added).
Friedlaender et al. (2001) reported on the results of a randomized, controlled, single- blind multi-center clinical trial where 122 patients with 124 tibial nonunions were assigned to either OP-1 Implant or bone autograft. The OP-1 Implant was found to be less effective than bone autograft. After 9 months of treatment, 81 % of the OP-1-treated nonunions and 85 % of patients receiving autogenous bone were judged by clinical criteria to have been treated successfully, and 75 % of OP-1 treated patients and 84 % of autograft-treated patients had healed fractures by radiographic criteria.
In a randomized study, Johnsson et al (2002) examined whether OP-1 (BMP-7) in the OP-1 Implant yields better stabilizing bony fusion than autograft bone in patients undergoing posterolateral fusion between L5 and S1. A total of 20 patients were randomized to fusion with either OP-1 Implant (n = 10) or autograft bone from the iliac crest (n = 10). The patients were instructed to keep the trunk straight for 5 months after surgery with the aid of a soft lumbar brace. At surgery 0.8-mm metallic markers were positioned in L5 and the sacrum, enabling radio-stereometric follow-up analysis during 1 year. No significant difference was observed between the radio-stereometric and radiographic results of fusion with the OP-1 Implant and fusion with autograft bone. Thus, the OP-1 Implant did not yield better stabilizing bony fusion than autograft bone.
Sandhu et al (2003) stated that OP-1 has been studied in limited pilot studies of posterolateral fusion. It is unclear whether the addition of OP-1 ensures arthrodesis in this application.
Vaccaro et al (2008) examined the safety and the clinical and radiographical efficacy of OP-1 (rhBMP-7) Putty as compared with an iliac crest bone autograft control in un-instrumented, single-level postero-lateral spinal arthrodesis. A total of 335 patients were randomized in 2:1 fashion to receive either OP-1 Putty or autograft for degenerative spondylolisthesis and symptomatic spinal stenosis. Patients were observed serially with radiographs, clinical examinations, and appropriate clinical indicators, including Oswestry Disability Index (ODI), Short-Form 36, and visual analog scale scores. Serum samples were examined at regular intervals to assess the presence of antibodies to OP-1. The primary end point, "overall success", was analyzed at 24 months. The study was extended to include additional imaging data and long-term clinical follow-up at 36+ months. At the 36+ month time point, CT scans were obtained in addition to plain radiographs to evaluate the presence and location of new bone formation. Modified overall success, including improvements in ODI, absence of re-treatment, neurological success, absence of device-related serious adverse events, angulation and translation success, and new bone formation by CT scan (at 36+ months), was then calculated using the 24-month primary clinical endpoints, updated retreatment data, and CT imaging and radiographical end points. OP-1 Putty was demonstrated to be statistically equivalent to autograft with respect to the primary end point of modified overall success. The use of OP-1 Putty when compared to autograft was associated with statistically lower intra-operative blood loss and shorter operative times. Although patients in the OP-1 Putty group demonstrated an early propensity for formation of anti-OP-1 antibodies, this resolved completely in all patients with no clinical sequelae. The authors concluded that OP-1 Putty is a safe and effective alternative to autograft in the setting of un-instrumented postero-lateral spinal arthrodesis performed for degenerative spondylolisthesis and symptomatic spinal stenosis.
Bone morphogenetic protein-2 (BMP-2) was approved by the FDA as a bone graft substitute in anterior lumbar interbody fusions. It has also been used off-label in anterior cervical fusions. Smucker and colleagues (2006) examined if BMP-2 is associated with an increased incidence of clinically relevant post-operative pre-vertebral swelling problems in patients undergoing anterior cervical fusions. A total of 234 consecutive patients (aged 12 to 82 years) undergoing anterior cervical fusion with and without BMP-2 over a 2-year period at one institution comprised the study population. The incidence of clinically relevant pre-vertebral swelling was calculated. The populations were compared and statistical significance was determined. A total of 234 patients met the study criteria, 69 of whom underwent anterior cervical spine fusions using BMP-2; 27.5 % of those patients in the BMP-2 group had a clinically significant swelling event versus only 3.6 % of patients in the non-BMP-2 group. This difference was statistically significant (p < 0.0001) and remained so after controlling for other significant predictors of swelling. The authors concluded that off-label use of BMP-2 in the anterior cervical spine is associated with an increased rate of clinically relevant swelling events.
In a systemic review, Mussano et al (2007) examined if BMPs are more effective in treating bone defects than traditional techniques, such as grafting autologous bone. An electronic search was made in the databases of MEDLINE, EMBASE (through MeSH and Emtree), and the Cochrane Central Register of Controlled Trials with no linguistic restrictions. Randomized controlled trials (RCTs) that compared bone regeneration achieved through BMPs versus that obtained by traditional methods entered the study. The 17 publications that met the criteria, divided into subgroups by type of bone, were tabulated by salient characteristics and evaluated through the items proposed by van Tulder et al. However, as the studies differed widely (in terms of site, sample size, dosage of active principle, carrier, clinical and radiological data recording), it was possible to carry out a meta-analysis of clinical and radiological outcome only for the subgroup that evaluated the vertebrae, where it was observed that BMPs offer a slightly but statistically significant greater efficacy than do traditional techniques. The authors concluded that the use of BMPs at the vertebrae can eliminate the need for surgery to harvest autologous bone. The only large study carried out on the other sites suggested that BMPs should be used at a concentration of 1.5 mg/ml to treat fractures of the tibia. The authors stated that further RCTs of good methodological quality are needed to clarify the effectiveness of BMPs in clinical practice.
The Pro Osteon Bone Graft Substitute (Interpore International) is a hydroxyapatite bone allograft material made from marine coral. The product was approved by the FDA in 1992 as a bone void filler for repair of metaphyseal defects and long bone cyst and tumor defects. The product is to be used in conjunction with rigid internal fixation, as the Pro Osteon does not possess sufficient strength to support the reduction of a defect site prior to hard tissue ingrowth. External stabilization is not sufficient.
Pro Osteon coralline hydroxyapatite is not indicated for spinal fusion or fractures of the epiphyseal plate. A prospective randomized controlled clinical study directly compared coralline hydroxyapatite to iliac crest grafts in spinal fusion and found that the coralline graft "does not possess adequate structural integrity to resist axial loading and maintain disc height or segmental lordosis during cervical interbody fusion" (McConnell et al, 2003).
The INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device (Medtronic Sofamor Danek) includes recombinant human bone morphogenic protein 2 (rhBMP-2) in a collagen absorbable sponge and a tapered titanium spinal cage, and has been approved for spinal fusion in persons with single-level degenerative disc disease from L4 to S1, where the patient has had at least 6 months of nonoperative treatment, and the device is to be used via an anterior approach. Studies submitted to the FDA compared the INFUSE Bone Graft to autogenous iliac crest bone graft in patients with degenerative lumbar disc disease. These studies showed clinically equivalent fusion rates between the 2 groups, with similar outcomes in terms of back pain, leg pain, disability and neurological status. The primary advantage of use of the device is that it does not require harvesting of autologous bone.
The California Technology Assessment Forum (CTAF) (Feldman, 2005) concluded that rhBMP-2 carried on a collagen sponge used in conjunction with an FDA approved device meets CTAF criteria for the treatment of patients undergoing single level anterior lumbar interbody spinal fusion for symptomatic single level degenerative disease at L4 to S1 of at least 6 months duration that has not responded to non-operative treatments. The California Technology Assessment Forum concluded that all other uses of rhBMP-2 including its use in cervical spinal fusions and for treatment of open tibial fracture do not meet CTAF criteria.
An evidence review prepared for the Ontario Ministry of Health and Long-Term Care (2004) found that "[t]he largest number of spinal fusion cases using BMP devices has been for anterior lumbar interbody fusion. Although radiologic fusion occurs at a consistently faster rate among recipients of the BMP device than among recipients of autologous bone grafts, clinical outcomes (pain and disability) appear no different. Regardless of technique, improvements in pain and disability are reported by similar proportions of participants in all the arms of all the trials."
In a study on occipito-cervical fusion using recombinant human BMP-2, Shahlaie and Kim (2008) stated that INFUSE should not be routinely used for occipito-cervical fusion. They noted that further studies are needed to determine if modified techniques such as intra-operative steroids and extended post-operative use of wound drains, can improve safety of its use in the posterior cervical region.
Platelet-Rich Plasma
Regeneration of guided bone is an established procedure used in implant dentistry to increase the quality and quantity of the host bone in sites of localized alveolar defects. Improvement in the osteo-inductive properties of currently available grafting materials is needed because of the lack of predictability in osseous regenerative procedures with these materials. Platelet-rich plasma (PRP), a modification of fibrin glue derived from autologous blood, is being used to deliver growth factors in high concentration to areas requiring osseous grafting. Growth factors released from the platelets include platelet-derived growth factor, transforming growth factor beta, platelet-derived epidermal growth factor, platelet-derived angiogenesis factor, insulin-like growth factor 1, and platelet factor 4. These factors signal the local mesenchymal and epithelial cells to migrate, divide, and increase collagen and matrix synthesis. PRP, as an adjunctive material with bone grafts during augmentation procedures, has been suggested to increase quality of bone regeneration and the rate of bone deposition.
In a randomized controlled study (n = 10), Kassolis and Reynolds (2005) compared bone formation after sub-antral maxillary sinus augmentation with freeze-dried bone allograft (FDBA) plus PRP versus FDBA plus resorbable membrane. The authors reported that the combination of FDBA and PRP enhanced the rate of formation of bone compared with FDBA and membrane, when used in sub-antral sinus augmentation. The investigators concluded, however, that more studies are needed to determine if such incremental enhancements in bone formation affect clinical outcome.
In a randomized controlled study, Camargo et al (2005) compared the clinical effectiveness of a combination therapy consisting of bovine porous bone mineral (BPBM), guided tissue regeneration (GTR), and PRP in the regeneration of periodontal intra-bony defects in humans. Twenty-eight paired intra-bony defects were surgically treated using a split-mouth design. Defects were treated with BPBM, GTR, and PRP (experimental), or with open-flap debridement (control). Clinical parameters evaluated included changes in attachment level, pocket depth, and defect fill as revealed by re-entry at 6 months. Pre-operative pocket depths, attachment levels, and trans-operative bone measurements were similar for the 2 groups. Post-surgical measurements taken at 6 months revealed that both treatment modalities significantly decreased pocket depth and increased clinical attachment and defect fill compared to baseline. The differences between the experimental and control groups were 2.22 (+/- 0.39) mm on buccal and 2.12 (+/- 0.34) mm on lingual sites for pocket depth, 3.05 (+/- 0.51) mm on buccal and 2.88 (+/- 0.46) mm on lingual sites for gain in clinical attachment, and 3.46 (+/- 0.96) mm on buccal and 3.42 (+/- 0.02) mm on lingual sites for defect fill. These differences between groups were statistically significant in favor of the experimental defects. The combined therapy was also clinically more effective than open-flap debridement. The authors stated that the superiority of the experimental group could not be attributed solely to the surgical intervention and was likely a result of the BPBM/GTR/ PRP application. The authors concluded that combining BPBM, GTR, and PRP was an effective modality of regenerative treatment for intra-bony defects in patients with advanced periodontitis.
Lekovic and colleagues (2003) examined the effectiveness of PRP, BPBM and GTR used in combination as regenerative treatment for grade II molar furcation defects in humans (n = 52). These investigators concluded that the PRP/BPBM/GTR combined technique is an effective modality of regenerative treatment for mandibular grade II furcation defects. Moreover, they stated that further studies are necessary to elucidate the role played by each component of the combined therapy in achieving these results.
Recent reviews have reached contradictory findings regarding the effectiveness of PRP for bone grafting. Marx (2004) stated that PRP remains the only effective growth factor preparation available to oral and maxillofacial surgeons as well as other dental specialists for outpatient use. In contrast, Freymiller and Aghaloo (2004) stated: "Practitioners involved with bone grafting have high hopes that PRP will be proven to be of benefit in bone graft healing. However, at this early stage of investigation, the results are inconclusive. There is still much to learn regarding PRP before this adjunctive material should be considered for routine use. Unfortunately, this has not been the case because an entire industry has developed to manufacture the equipment and supplies needed for surgeons to prepare PRP in the office or operating room. Courses are being offered throughout the United States touting the benefits of PRP. Considering the meager volume and contradictory nature of the currently available evidence, there appears to be a disproportionate use of PRP in clinical practice." These authors concluded that more research (especially well-designed, rigorous, standardized human trials) is needed before evidence-based surgeons can feel confident in recommending this procedure/material to their patients.
These conclusions are in agreement with the observations of Sanchez et al (2003) and Grageda (2004). Sanchez et al (2003) stated that "there is clearly a lack of scientific evidence to support the use of PRP in combination with bone grafts during augmentation procedures. This novel and potentially promising technique requires well-designed, controlled trials to provide evidence of effectiveness." Grageda (2004) stated that since the introduction of PRP, several investigators have examined its effectiveness using various bone grafting materials. There have been different protocols as well as different types of clinical cases. The author concluded that "there is an urgent need not just for more, but for standardized research studies in this subject to provide evidence-based dentistry to patients. Without the standardization of these protocols, it will be extremely difficult to ascertain whether PRP enhances bone healing when it is used alone or in conjunction with bone grafting materials."
A systematic evidence review of surgical techniques for placing dental implants prepared for the Cochrane Collaboration (Coulthard et al, 2003) concluded that there is no strong evidence that the use of PRP or other variations in surgical technique described in the review for placing implants have superior success rates.
Devices to prepare PRP have been cleared by the FDA based on 510(k) premarket notification. The FDA has required that the product labeling for one such device state that "[t]he Platelet Rich Plasma prepared by this device has not been evaluated for any clinical indications" (Golding, 2004).
Recent studies also produced contradictory findings on the clinical value of PRP. While Okuda et al (2005) reported that treatment with a combination of PRP and porous hydroxyapatite (HA) compared to HA with saline led to a significantly more favorable clinical improvement in intra-bony periodontal defects (n = 70), and Sammartino et al (2005) found that PRP is effective in inducing and accelerating bone regeneration for the treatment of periodontal defects at the distal root of the mandibular second molar after surgical extraction of a mesioangular, deeply impacted mandibular third molar (n = 18), results from other studies indicated that PRP does not provide any added benefits.
In a randomized controlled study (n = 24), Huang et al (2005) examined the effects of PRP in combination with coronally advanced flap (CAF) for the treatment of gingival recession. These investigators concluded that the application of PRP in CAF root coverage procedure provides no clinically measurable enhancements on the final therapeutic outcomes of CAF in Miller's Class I recession defects. Furthermore, in a controlled clinical trial (n = 10), Monov et al (2005) found that the instillation of PRP during implant placement in the lower anterior mandible did not add additional benefit. These findings are in agreement with the observation of Raghoebard et al (2005) who noted that no beneficial effect of PRP on wound healing and bone remodeling of autologous bone grafts used for augmentation of the floor of the maxillary sinus.
In a review on the role of PRP in sinus augmentation, Boyapati and Wang (2006) stated that although the lateral wall sinus lift is a predictable clinical procedure to increase vertical bone height resulting in implant success rates comparable to that of native bone, the issue of extended healing periods remains troublesome. Clinicians and researchers have investigated several methods, including addition of growth factors and peptides, to reduce this healing time and enhance bone formation within the subantral environment. Platelet-rich plasma is an autologous blood product containing high concentrations of several growth factors and adhesive glycoproteins. The incorporation of PRP into the sinus graft has been proposed as a method to shorten healing time, enhance wound healing, and improve bone quality. These investigators noted that currently, the literature is conflicting with respect to the adjunctive use of PRP in sinus augmentation. Factors that may contribute to this variability include variable/inappropriate study design, under-powered studies, differing platelet yields, and differing graft materials used. In addition, methods of quantifying bone regeneration and wound healing differ between studies. Currently, because of limited scientific evidence, the adjunctive use of PRP in sinus augmentation cannot be recommended. The authors stated that further prospective clinical studies are urgently needed.
In a randomized controlled trial, de Vos et al (2010) examined if a PRP injection would improve outcome in chronic mid-portion Achilles tendinopathy. A stratified, block-randomized, double-blind, placebo-controlled study at a single center of 54 randomized patients aged 18 to 70 years with chronic tendinopathy 2 to 7 cm above the Achilles tendon insertion were carried out. The trial was conducted between August 28, 2008, and January 29, 2009, with follow-up until July 16, 2009. Subjects received eccentric exercises (usual care) with either a PRP injection (PRP group) or saline injection (placebo group). Randomization was stratified by activity level. Main outcome measure was the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire, which evaluated pain score and activity level; and was completed at baseline and 6, 12, and 24 weeks. The VISA-A score ranged from 0 to 100, with higher scores corresponding with less pain and increased activity. Treatment group effects were evaluated using general linear models on the basis of intention-to-treat. After randomization into the PRP group (n = 27) or placebo group (n = 27), there was complete follow-up of all patients. The mean VISA-A score improved significantly after 24 weeks in the PRP group by 21.7 points (95 % confidence interval [CI]: 13.0 to 30.5) and in the placebo group by 20.5 points (95 % CI: 11.6 to 29.4). The increase was not significantly different between both groups (adjusted between-group difference from baseline to 24 weeks, -0.9; 95 % CI: -12.4 to 10.6). This CI did not include the pre-defined relevant difference of 12 points in favor of PRP treatment. The authors concluded that among patients with chronic Achilles tendinopathy who were treated with eccentric exercises, a PRP injection compared with a saline injection did not result in greater improvement in pain and activity.
In a decision memorandum, the Centers for Medicare & Medicaid Services (CMS, 2008) determined that the evidence is inadequate to conclude that autologous PRP for the treatment of chronic non-healing cutaneous wounds, acute surgical wounds when the autologous PRP is applied directly to the closed incision, or dehiscent wounds improves health outcomes. Therefore, CMS determined that PRP is not reasonable and necessary for the treatment of these indications. Consequently, CMS issued a non-coverage determination for acute surgical wounds when the autologous PRP is applied directly to the closed incision and for dehiscent wounds. CMS also maintained the current non-coverage for chronic, non-healing cutaneous wounds.
In a systematic review on the safety and effectiveness of the use of autologous PRP for tissue regeneration, Martínez-Zapata et al (2009) concluded that PRP improves the gingival recession but not the clinical attachment level in chronic periodontitis. In the complete healing process of chronic skin ulcers, the results are inconclusive. There are little data regarding the safety of PRP. There are several methodological limitations and, consequently, future research should focus on strong and well-designed RCTs that evaluate the safety and effectiveness of PRP.
Guidelines from the Work Loss Data Institute (2008) on work-related disorders of the elbow state that platelet-rich plasma and autologous blood donation are under study and are not specifically recommended.
An assessment by the Institute for Clinical Effectiveness and Health Policy (IECS, 2008) concluded that, "although in vitro, PRP has demonstrated to release growth factors and to improve tendon structure, so far, there is no evidence supporting its use in human beings."
Porcine Intestinal Submucosa Surgical Mesh
The rotator cuff is comprised of four muscles (i.e., infraspinatus, subscapularis, supraspinatus and teres minor) that originate from the scapula. The tendons of these muscles form a single tendon unit, which inserts onto the greater tuberosity of the humerus. These "structures" combine to form a "cuff" over the head of the humerus. The rotator cuff helps to lift and rotate the arm as well as to stabilize the ball of the shoulder within the joint.
Tears of the rotator cuff tendons are one of the most common causes of pain, loss of motion, and disability in adults. Traditional treatments include conservative interventions (e.g., rest and limited overhead activity, use of a sling, non-steroidal anti-inflammatory drugs, oral glucocorticoid, strengthening exercise and physical therapy, intra-articular or subacromial glucocorticosteroid injection), and surgery (arthroscopic or open). Non-surgical treatments, which may take several weeks or months, produce pain relief in approximately 50 % of patients and no improvement in strength at long-term follow-up, whereas surgical intervention results in pain relief in about 85 % of patients and a better return of strength (Ruotolo and Nottage, 2002). Following rotator cuff repair surgery, the arm is immobilized to allow the tear to heal. The length of immobilization is usually dependent on the severity of the tear. Furthermore, patients' commitment/compliance to rehabilitation is important to attain a good surgical outcome.
Recent developments in rotator cuff repair surgery include newer arthroscopic and mini-open surgical techniques. These new techniques are intended to allow for smaller, less painful incisions and faster recovery time. Many of these advances use dissolvable anchors, which hold sutures in place or hold sutures down to bone until the repair has healed and then are absorbed by the body. There is also ongoing research on orthobiologic tissue implants that is intended to enhance healing and promote growth of new tissue.
A surgical mesh composed of porcine small intestinal submucosa (Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc., Warsaw, IN) was cleared for marketing based on a FDA 510(k) premarket notification in December 2000. The implant is manufactured from 10 layers of small intestine submucosa derived from porcine small intestine and is mainly composed of water and collagen. According to the FDA, this surgical mesh implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a resorbable scaffold that initially has sufficient strength to assist with a soft tissue repair, but then resorbs and is replaced by the patient's own tissue. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues, which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff surgery. According to the manufacturer, this surgical mesh implant is intended to give the surgeon a less invasive treatment when the rotator cuff tissue is of poor quality or the repair needs reinforcement.
Although the Restore orthobiologic implant has been cleared by the FDA for marketing, there is a lack of adequate evidence on the effectiveness of this implant in rotator cuff repair. Malcarney et al (2005) presented a case series of 25 patients who underwent rotator cuff repair by one surgeon using this implant to augment the repaired tendon or fill a defect. Four of 25 patients (16 %) experienced an overt inflammatory reaction at a mean of 13 days post-operatively. All patients underwent open irrigation and debridement of the rotator cuff and the implant. The authors concluded that these porcine surgical mesh implants should be used with caution and with the understanding that an early post-operative non-specific inflammatory reaction can occur that may cause breakdown of the repair. Furthermore, these investigators stated that more studies are needed to further characterize the reaction and determine which patients are susceptible.
Zheng et al (2005) stated that the small intestinal submucosa (SIS) that is used in this implant is not an acellular collagenous matrix, and contains porcine DNA. They suggested that further studies should be conducted to evaluate the clinical safety and effectiveness of SIS implant biomaterials.
The most frequent side effects encountered in soft tissue repair include infection, adhesions, sterile effusion, instability, increased stiffness post-operatively, and general risks associated with surgery and anesthesia such as neurological, cardiac, and respiratory deficit. Potential device-related risks include stretching or tearing of the device, stiffness, chronic synovitis or effusion, prolonged post-operative rehabilitation, delayed or failed incorporation of the device as well as immunological reaction. Moreover, the porcine surgical mesh implant is contraindicated in patients with massive chronic rotator cuff tears that cannot be mobilized, or where the muscle tissue has undergone substantial fatty degeneration.
Fibrin glue has been used to treat anorectal fistulas in an attempt to avoid more radical surgical intervention. Fibrin glue treatment is simple and repeatable; failure does not compromise further treatment options; and sphincter function is preserved. However, reported success rates vary widely. Suturable bioprosthetic plugs (Surgisis, Cook Surgical, Inc.) have been employed to close the primary opening of fistula tracts. Surgisis is a new 4- or 8-ply bioactive, prosthetic mesh for hernia repair derived from porcine SIS. In a review on resorbable extra-cellular matrix grafts in urological reconstruction, Santucci and Barber (2005) noted that recent problems with inflammation following 8-ply pubo-vaginal sling use and failures after 1- and 4-ply SIS repair of Peyronie's disease underscore the need for research before wide adoption.
In a prospective cohort study, Johnson and Armstrong (2006) compared fibrin glue versus the anal fistula plug. Patients with high trans-sphincteric fistulas, or deeper, were prospectively enrolled. Patients with Crohn's disease or superficial fistulas were excluded. Age, gender, number and type of fistula tracts, and previous fistula surgeries were compared between groups. Under general anesthesia and in prone jack-knife position, the tract was irrigated with hydrogen peroxide. Fistula tracts were occluded by fibrin glue versus closure of the primary opening using a Surgisis anal fistula plug. A total of 25 patients were prospectively enrolled: 10 patients underwent fibrin glue closure, and 15 used a fistula plug. Patient's age, gender, fistula tract characteristics, and number of previous closure attempts was similar in both groups. In the fibrin glue group, 6 patients (60 %) had persistence of one or more fistulas at 3 months, compared with 2 patients (13 %) in the plug group (p < 0.05, Fisher exact test). The authors concluded that closure of the primary opening of a fistula tract using a suturable biologic anal fistula plug is an effective method of treating anorectal fistulas. The method seems to be more reliable than fibrin glue closure. The greater efficacy of the fistula plug may be the result of the ability to suture the plug in the primary opening, therefore, closing the primary opening more effectively. These investigators noted that further prospective, long-term studies are warranted.
A guidance document from the National Institute for Health and Clinical Excellence (NICE, 2006) found insufficient evidence to support the use of porcine intestinal submucosa plugs for repair of anorectal fistula. The NICE assessment concluded: "Current evidence suggests that there are no major safety concerns associated with the closure of anal fistula (fistula in ano) using a suturable bioprosthetic plug. However, evidence on the efficacy of the procedure is not adequate for it to be used without special arrangements for consent and for audit or research." The specialist advisors to NICE commented that there was uncertainty about recurrence rates and the long-term outcomes of this procedure.
Schwandner and Fuerst (2009) analyzed the efficacy of the Surgisis(R) AFP(TM) anal fistula plug and the Surgisis(R) mesh for the closure of complex fistulas in Crohn's disease. All patients with peri-anal Crohn's disease suffering from trans-sphincteric and recto-vaginal fistulas who underwent surgery using the Surgisis(R) anal fistula plug or the Surgisis(R) mesh were prospectively enrolled in this study. Inclusion criteria included trans-sphincteric single-tract fistulas and recto-vaginal fistulas. Surgery was performed using a standardized technique, including irrigation of the fistula tract, placement and internal fixation of the Surgisis(R) anal fistula plug, and combined trans-anal/trans-vaginal excision of recto-vaginal fistula with trans-vaginal placement of the mesh. Success was defined as closure of both internal and external (peri-anal or vaginal) openings, absence of drainage without further intervention, and absence of abscess formation. Follow-up information was obtained from clinical examination 3, 6, 9, and 12 months post-operatively. Within the observation period, a total of 16 procedures were performed. After a mean follow-up of 9 months and 1 patient lost to follow-up, the overall success rate was 75 %. For trans-sphincteric fistulas, the success rate was 77 %, whereas it was 66 % in recto-vaginal fistulas associated with Crohn's disease. All 4 patients with failure had re-operation. Rate of stoma reversal in those patients who had fecal diversion was 66 %. No deterioration of continence was documented. The authors concluded that the short-term success rates are promising; further analysis is needed to explain the definite role of this technique in comparison with traditional surgical techniques.
Safar et al (2009) analyzed the efficacy of the Cook Surgisis AFP anal fistula plug for the management of complex anal fistulas. This was a retrospective review of all patients prospectively entered into a database at the authors' institution who underwent treatment for complex anal fistulas using Cook Surgisis AFP anal fistula plug between July 2005 and July 2006. Patient's demographics, fistula etiology, and success rates were recorded. The plug was placed in accordance with the inventor's guidelines. Success was defined as closure of all external openings, absence of drainage without further intervention, and absence of abscess formation. A total of 35 patients underwent 39 plug insertions (22 men; mean age of 46 (range of 15 to 79) years). Three patients were lost to follow-up, therefore, 36 procedures to be analyzed. The fistula etiology was crypto-glandular in 31 (88.6 %) patients and Crohn's disease associated in the other 4 (11.4 %). There were 11 smokers and 3 patients with diabetes. The mean follow-up was 126 days (standard = 69.4). The overall success rate was 5 of 36 (13.9 %). One of the 4 Crohn's disease-associated fistulas healed (25 %) and 4 of 32 (12.5 %) procedures resulted in healing of crypto-glandular fistulas. In 17 patients, further procedures were necessary as a result of failure of treatment with the plug. The reasons for failure were infection requiring drainage and seton placement in 8 patients (25.8 %), plug dislodgement in 3 (9.7 %), persistent drainage/tract and need for other procedures in 20 patients (64.5 %). The authors concluded that the success rate for Surgisis AFP anal fistula plug for the treatment of complex anal fistulas was (13.9 %), which is much lower than previously described. They stated that further analysis is needed to explain significant differences in outcomes.
Bone Void Fillers for Nonunions
Minimally invasive injectable graft (MIIG) (Wright Medical Technology, Inc., Arlington, TN) is an example of a bone void filler, and is a paste made with calcium sulphate (plaster of Paris). It is injected into osseous defects that are created surgically or as a result of trauma. The paste cures in-situ, resorbs, and then is replaced with bone during the healing process. The cured paste provides a temporary support media for bone fragments during the surgical procedure but does not provide structural support during the healing process. Injection of MIIG is usually performed in conjunction with another procedure, such as reduction of a fracture. Minimally invasive injectable graft was cleared by the FDA through the 510(k) process since it is substantially equivalent to other bone void fillers on the market.
Integra Mozaik Osteoconductive Scaffold (OS) putty (Integra LifeSciences Corp., Plainsboro, NJ) is a synthetic bone void filler manufactured from beta tri-calcium phosphate and type I bovine collagen. Combined with bone marrow aspirate, Integra Mozaik OS is intended for use as a bone void filler of the skeletal system in the extremities, spine,and pelvis. Integra Mozaik OS putty was cleared by the FDA through the 510(k) process since it is substantially equivalent to another bone void filler on the market. According to the FDA 510(k) letter to the manufacturer, it is specifically indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the body void or gap (defect), Integra Mozaik putty is resorbed and replaced with bone during the healing process.
There is insufficient evidence to support the use of MIIG, Integra Mozaik OS putty, or other bone void fillers as a treatment for delayed union or nonunions. Furthermore, a technology assessment prepared by ECRI for Agency for Healthcare Research and Quality (2005) concluded that there is no reliable evidence to support the use of calcium sulphate or other bone void fillers as treatments for delayed fracture healing.
A retrospective case series examined the use of AlloMatrix injectable putty in nonunions in multiple bone types (Wilkins and Kelly, 2003). The nonunions were also treated using standard internal/external fixation techniques. The publication did not report prior treatment or the duration of the nonunions prior to the AlloMatrix putty treatment. A technology assessment prepared by the ECRI Institute (Schoelles et al, 2005) for the Agency for Healthcare Research and Quality, commenting on this study, stated that "[w]ithout this information, interpretation of the results is difficult". The study also did not report whether all consecutively treated patients were included or if dropouts occurred during the treatment period. The reported healing rate was 30 of 35 (85 %) in an average of 3.5 months, but healing rates per bone type were not reported.
A subsequent study by Ziran and colleagues (2007) reported on an unacceptably high rate of complications with the use of Allomatrix for nonunions. A consecutive series of patients requiring bone grafting for atrophic/avascular nonunions were retrospectively studied. Patients were monitored for healing and adverse effects, which included local or systemic reactions, wound problems, infection, and any secondary surgery caused by graft complications. The investigators reported that over half of the patients (51 %) developed post-operative drainage. Of the 41 patients, 13 (32 %) had drainage that required surgical intervention and 14 (34 %) developed a deep infection. Eleven patients with deep infections also required surgical treatment of drainage. In addition, 19 (46 %) patients did not heal and required secondary surgical intervention. The investigators reported that there were correlations between infection and a history of previously treated infection (p < 0.007), as well as wound drainage (p < 0.001). Failure of treatment correlated to the presence of a post-operative infection (p < 0.001). Other analyses were not performed because of the small sample size, which was because of early termination of the study. The investigators concluded that the use of Allomatrix putty as an alternative for autogenous bone graft in the treatment of nonunions resulted in an unacceptably high rate of complications. The investigators stated: "[a]lthough we recommend further study, we do not recommend the use of Allomatrix for the treatment of nonunions, especially if there is a large volumetric defect or a history of any prior contamination of the tissue bed".
Mesenchymal Stem Cell
Mesenchymal stem cells or MSCs are multipotent stem cells that can differentiate into a variety of cell types. Mesenchymal stem cells have been classically obtained from the bone marrow, and have been shown to differentiate into various cell types, including osteoblasts, chondrocytes, myocytes, adipocytes, and neuronal cells.
Helm and colleagues (2001) stated that although autologous bone remains the gold standard for stimulating bone repair and regeneration, the advent in molecular biology as well as bioengineering techniques has produced materials that exhibit potent osteogenic activities. Recombinant human osteogenic growth factors (e.g., BMP) are now produced in highly concentrated and pure forms and have been shown to be extremely potent bone-inducing agents when delivered in vivo in rats, dogs, primates, and humans. They noted that the delivery of MSCs, derived from adult bone marrow, to regions requiring bone formation is also compelling, and it has been shown to be successful in inducing osteogenesis in many pre-clinical animal studies. Finally, the identification of biological and non-biological scaffolding materials is a crucial component of future bone graft substitutes, not only as a delivery vehicle for bone growth factors and MSCs, but also as an osteo-conductive matrix to stimulate bone deposition directly.
Recently, MSCs has been studied for its use in orthopedic application (e.g., healing long bone defects, intervertebral disc repair and regeneration as well as spinal arthrodesis procedures). Acosta et al (2005) noted that although important obstacles to the survival and proliferation of MSCs within the degenerating intervertebral disc need to be overcome, the potential for this therapy to slow or reverse the degenerative process remains substantial. Leung et al (2006) stated that in the past several years, significant progress has been made in the field of stem cell regeneration of the intervertebral disc. Autogenic MSCs in animal models can arrest intervertebral disc degeneration or even partially regenerate it, and the effect is suggested to be dependent on the severity of degeneration. Mesenchymal stem cells are able to escape alloantigen recognition which is an advantage for allogenic transplantation. A number of injectable scaffolds have been described and various methods to pre-modulate MSCs' activity have been tested. They noted that more work is needed to address the use of MSCs in large animal models as well as the fate of the implanted MSCs, especially the long-term outcomes.
Mclain et al (2005) noted that successful arthrodesis in challenging clinical scenarios is facilitated when the site is augmented with autograft bone. The iliac crest has long been the preferred source of autograft material, but graft harvest is associated with frequent complications and pain. Connective tissue progenitor cells aspirated from the iliac crest and concentrated with allograft matrix and demineralized bone matrix provide a promising alternative to traditional autograft harvest. The vertebral body, an even larger reservoir of myeloproliferative cells, should provide progenitor cell concentrations similar to those of the iliac crest. In this study, a total of 21 adults (11 men and 10 women with a mean age of 59 +/- 14 years) undergoing posterior lumbar arthrodesis and pedicle screw instrumentation underwent transpedicular aspiration of connective tissue progenitor cells. Aspirates were obtained from two depths within the vertebral body and were quantified relative to matched, bilateral aspirates from the iliac crest that were obtained from the same patient at the same time. Histochemical analysis was used to determine the prevalence of vertebral progenitor cells relative to the depth of aspiration, the vertebral level, age, and gender, as compared with the iliac crest standard. The cell count, progenitor cell concentration (cells/cc marrow), and progenitor cell prevalence (cells/million cells) were calculated. Aspirates of vertebral marrow demonstrated comparable or greater concentrations of progenitor cells compared with matched controls from the iliac crest. Progenitor cell concentrations were consistently higher than matched controls from the iliac crest (p = 0.05). The concentration of osteogenic progenitor cells was, on the average, 71 % higher in the vertebral aspirates than in the paired iliac crest samples (p = 0.05). With the numbers available, there were no significant differences relative to vertebral body level, the side aspirated, the depth of aspiration, or gender. An age-related decline in cellularity was suggested for the iliac crest aspirates. The authors concluded that the vertebral body is a suitable site for aspiration of bone marrow for graft augmentation during spinal arthrodesis. They also stated that future clinical studies will attempt to confirm the ability to obtain fusion using only this source of connective tissue progenitor cells.
Anderson and colleagues (2005) reviewed the rationale and discussed the results of cellular strategies that have been proposed or investigated for disc degeneration. These investigators noted that although substantial work remains, the future of cellular therapies for symptomatic disc degeneration appears promising. They concluded that continued research is warranted to further define the optimal cell type, scaffolds, and adjuvants that will allow successful disc repair in human patients.
Risbud and colleagues (2006) evaluated the osteogenic potential of MSCs isolated from the bone marrow of the human vertebral body (VB). Marrow samples from VB of patients undergoing lumbar spinal surgery were collected; marrow was also harvested from the iliac crest (IC). Progenitor cells were isolated and the number of colony forming unit-fibroblastic (CFU-F) determined. The osteogenic potential of the cells was characterized using biochemical and molecular biology techniques. Both the VB and IC marrow generated small, medium, and large sized CFU-F. Higher numbers of CFU-F were obtained from the VB marrow than the IC (p < 0.05). Progenitor cells from both anatomic sites expressed comparable levels of CD166, CD105, CD49a, and CD63. Moreover, progenitor cells from the VB exhibited an increased level of alkaline phosphatase activity. MSCs of the VB and the IC displayed similar levels of expression of Runx-2, collagen Type I, CD44, ALCAM, and ostecalcin. The level of expression of bone sialoprotein was higher in MSC from the IC than the VB. VB and IC cells mineralized their extracellular matrix to a similar extent. The authors concluded that their findings show that CFU-F frequency is higher in the marrow of the VB than the IC. Progenitor cells isolated from both sites respond in a similar manner to an osteogenic stimulus and express common immunophenotypes. Based on these findings, these researchers proposed that progenitor cells from the lumbar vertebral marrow would be suitable candidate for osseous graft supplementation in spinal fusion procedures. They stated that studies must now be conducted using animal models to ascertain if cells of the VB are as effective as those of the IC for the fusion applications.
Minamide et al (2007) examined the ability of BMP and basic fibroblast growth factor (FGF) to enhance the effectiveness of bone marrow-derived MSCs in lumbar arthrodesis. They found that MSCs cultured with BMP-2 and basic FGF act as a substitute for autograft in lumbar arthrodesis. This technique may yield a more consistent quality of fusion bone as compared to that with autograft. They stated that these results are encouraging and warrant further studies with the suitable dose of BMP-2 and basic FGF, and may provide a rational basis for their clinical application.
Further investigation is needed to study the value of MSC therapy in orthopedic applications before it can be used in the clinical setting.
Miscellaneous Interventions:
Cheng et al (2010) had previously isolated and identified stem cells from human anterior cruciate ligament (ACL). The purpose of this study was to evaluate the differences in proliferation, differentiation, and extracellular matrix (ECM) formation abilities between bone marrow stem cells (BMSCs) and ACL-derived stem cells (LSCs) from the same donors when cultured with different growth factors, including basic fibroblast growth factor (bFGF), epidermal growth factor, and transforming growth factor-beta 1 (TGF-beta1). Ligament tissues and bone marrow aspirate were obtained from patients undergoing total knee arthroplasty and ACL reconstruction surgeries. Proliferation, colony formation, and population doubling capacity as well as multi-lineage differentiation potentials of LSCs and BMSCs were compared. Gene expression and ECM production for ligament engineering were also evaluated. It was found that BMSCs possessed better osteogenic differentiation potential than LSCs, while similar adipogenic and chondrogenic differentiation abilities were observed. Proliferation rates of both LSCs and BMSCs were enhanced by bFGF and TGF-beta1. TGF-beta1 treatment significantly increased the expression of type I collagen, type III collagen, fibronectin, and alpha-smooth muscle actin in LSCs, but TGF-beta1 only up-regulated type I collagen and tenascin-c in BMSCs. Protein quantification further confirmed the results of differential gene expression and suggested that LSCs and BMSCs increase ECM production upon TGF-beta1 treatment. In summary, in comparison with BMSCs, LSCs proliferate faster and maintain an undifferentiated state with bFGF treatment, whereas under TGF-beta1 treatment, LSCs up-regulate major tendinous gene expression and produce a robust amount of ligament ECM protein, making LSCs a potential cell source in future applications of ACL tissue engineering.
Steinert et al (2011) noted that when ruptured, the ACL of the human knee has limited regenerative potential. However, the goal of this report was to show that the cells that migrate out of the human ACL constitute a rich population of progenitor cells and these researchers hypothesized that they display mesenchymal stem cell (MSC) characteristics when compared with adherent cells derived from bone marrow or collagenase digests from ACL. They showed that ACL outgrowth cells are adherent, fibroblastic cells with a surface immunophenotype strongly positive for cluster of differentiation (CD)29, CD44, CD49c, CD73, CD90, CD97, CD105, CD146, and CD166, weakly positive for CD106 and CD14, but negative for CD11c, CD31, CD34, CD40, CD45, CD53, CD74, CD133, CD144, and CD163. Staining for STRO-1 was seen by immunohistochemistry but not flow cytometry. Under suitable culture conditions, the ACL outgrowth-derived MSCs differentiated into chondrocytes, osteoblasts, and adipocytes and showed capacity to self-renew in an in vitro assay of ligamentogenesis. MSCs derived from collagenase digests of ACL tissue and human bone marrow were analyzed in parallel and displayed similar, but not identical, properties. In situ staining of the ACL suggests that the MSCs reside both aligned with the collagenous matrix of the ligament and adjacent to small blood vessels. The authors concluded that the cells that emigrate from damaged ACLs are MSCs and that they have the potential to provide the basis for a superior, biological repair of this ligament.
According to information from the manufacturer, BIO MatrX Structure is a highly porous, synthetic bone graft substitute that sets hard upon implantation for a complete defect fill. The manufacturer states that the resulting osteoconductive scaffold provides inter-connected porosity and high surface area to facilitate cell mediated remodeling and new bone growth. BIO MatrX Generate is a combination of osteoconductive nano-crystalline calcium phosphate and Demineralized Bone Matrix (DBM) that is tested for osteoinductive potential by lot, after sterilization, in an in-vivo athymic nude rodent muscle pouch model. The viscous putty sets hard after closure providing an osteoconductive scaffold to facilitate new bone growth. The manufacturer states that both materials are FDA-cleared to be hydrated with saline or blood; and are indicated as bone void fillers of the pelvis, extremities and the postero-lateral spine.
The use of minced cartilage techniques are in the early stages of development. According to the manufacturer, DeNovo NT was developed as a consequence of the need for expanded treatment options for the treatment of cartilage lesions. DeNovo NT (natural tissue) graft and DeNovo ET live chondral engineered tissue graft (Neocartilage) are produced by ISTO Technologies (St. Louis, MO), and exclusively distributed by Zimmer, Inc. (Warsaw, IN). DeNovo NT consists of manually minced cartilage tissue pieces obtained from juvenile allograft donor joints. The tissue fragments are mixed intra-operatively with fibrin glue before implantation. It is thought that mincing the tissue helps with cell migration. As there are no chemicals used and minimal manipulation, it is regulated as an allograft tissue rather than a biological implant. Thus, the allograft tissue does not require FDA approval for marketing. DeNovo NT is currently available in the U.S. Neocartilage uses juvenile allogeneic cartilage cells that are isolated and expanded in-vitro, similar to other ACI techniques. Neocartilage is currently being studied in human clinical trials under an FDA-approved investigational new drug (IND) application. The FDA approved ISTO's IND application in 2006, which allowed them to pursue clinical trials of the product in humans. There are no studies evaluating the DeNovo ET tissue graft in the published medical literature.
There are no studies evaluating the DeNovo NT graft in the published medical literature. The manufacturer of DeNovo NT has initiated a post-market, multi-center, longitudinal data collection study to collect clinical outcomes of subjects implanted with DeNovo NT. Data are to be obtained either retrospectively or prospectively from patients implanted or to be implanted with DeNovo NT for the treatment of lesion in the ankle. Data to be collected include details of the operative procedure as well as subjects' pain, function, activity levels, and healthcare resource use through a 5-year post-operative follow-up period. Four U.S. sites are participating in this manufacturer-sponsored observational study with 25 subjects; the study began in 2006 and is expected to be completed in 2013.
Ky et al (2008) evaluated the effectivness of the Surgisis (Anal Fistula Plug) in multiple patients and presented early clinical results along with notable clinical observations from their experience. This was a prospective analysis of all patients who received the Anal Fistula Plug for treatment of anorectal fistulas between April 2006 and February 2007. All tracts were irrigated with peroxide, the plug was inserted in the tract, and buried at the internal opening with 2-0 vicryl and mucosal advancement flap. Statistical analysis was performed with Fisher's exact test. A total of 45 patients were treated with the Anal Fistula Plug and 1 patient was lost to follow-up. There were 27 males and 17 females with average age of 44.1 years treated for simple (n = 24) or complex (n = 20) fistulas. Preliminary results indicated an 84 % healing rate by 3 to 8 weeks post-operatively, which progressively declined from 72.7 % at 8 weeks to 62.4 % at 12 weeks and 54.6 % at a median follow-up of 6.5 (range of 3 to 13) months. Long-term Anal Fistula Plug closure rate was significantly higher in patients with simple than complex fistulas (70.8 versus 35 %; p < 0.02) and with non-Crohn's disease versus Crohn's disease (66.7 versus 26.6 %; p < 0.02). Patients with 2 successive plug placements had significantly lower closure rates than patients who underwent placement of the plug once (12.5 versus 63.9 %; p < 0.02). No significant difference in closure rates were found between patients with 1 versus multiple fistula tracts. Post-operative complications included peri-anal abscess in 5 patients (3 Crohn's disease, 2 non-Crohn's disease). The authors concluded that Anal Fistula Plug is most successful in the treatment of simple anorectal fistulas but is associated with a high failure rate in complex fistula and particularly in patients with Crohn's disease. Repeat plug placement is associated with increased failure. Given the relatively low morbidity associated with the procedure, Anal Fistula Plug should be considered as a first-line treatment for patients with simple fistulas and as an alternative in selected patients with complex fistulas. Drawbacks of this study were: (i) small sample size, (ii) short duration of follow-up, and (iii) high failure rate.
Buchberg et al (2010) compared the Cook Surgisis AFP plug and the newer Gore Bio-A plug in the management of complex anal fistulas. A retrospective chart review of patients treated with Cook and Gore fistula plugs between August 2007 and December 2009 was performed. Success was defined as closure of all external openings and absence of drainage and abscess formation. Twelve Cook patients underwent 16 plug insertions and 10 Gore patients underwent 11 plug insertions. The overall procedural success rate in the Gore group was 54.5 % (6 of 11) versus 12.5 % (2 of 16) in the Cook group. The reasons for failure were unknown in the majority of patients and plug dislodgement in 2 patients. These short-term results with the Gore fistula plug suggested a higher procedural success rate in comparison to the Cook plug. The authors concluded that patients should be cautioned regarding potentially high failure rates; however, longer follow-up and a larger patient population are needed to confirm significant differences in fistula plug efficacy.
CPT Codes / HCPCS Codes / ICD-9 Codes
Bone and Tendon Graft Substitutes and Adjuncts:
Other CPT codes related to the CPB:
20690 - 20694
Uniplane and multiplane fixation systems
Bone graft, any donor area; minor or small (e.g., dowel or button)
major or large
Bone graft with microvascular anastomosis; fibula
other than fibula, iliac crest, or metatarsal
Electrical stimulation to aid bone healing, noninvasive (nonoperative)
invasive (operative)
Low intensity ultrasound stimulation to aid bone healing, noninvasive (nonoperative)
22548 - 22819
Arthrodesis, spine [spinal fusion]
Application of intervertebral biomechanical device(s) (e.g., synthetic cage(s), methylmethacrylate) to vertebral defect or interspace (List separately in addition to code for primary procedure)
27301 - 27499
Femur (thigh region) and knee joint surgery
29065 - 29085
Application cast; upper extremity
29305 - 29355
Lower extremity casts
Bone age studies
HCPCS codes not covered for indications listed in the CPB:
Connective tissue, non-human (includes synthetic)
Other HCPCS codes related to the CPB:
Osteogenesis stimulator, electrical, noninvasive, other than spinal applications
Osteogenesis stimulator, electrical, surgically implanted
Casting supplies
Osteogenic Protein-1 (OP-1):
Other CPT codes related to the CPB:
22548 - 22819
Arthrodesis, spine [spinal fusion]
ICD-9 codes covered if selection criteria are met:
Malignant neoplasm of vertebral column, excluding sacrum and coccyx
Malignant neoplasm of spinal meninges
198.3 - 198.5
Secondary malignant neoplasms of brain, spinal cord, bone and bone marrow
225.3 - 225.4
Benign neoplasm of spinal cord and meninges
237.5 - 237.6
Neoplasm of uncertain behavior of brain, spinal cord and meninges
Neoplasm of uncertain behavior of bone and articular cartilage
Spinal stenosis, lumbar region
Pathologic fracture of vertebrae
Nonunion of fracture[long bone]
737.30 - 737.39
Kyphoscoliosis and scoliosis
Lordosis, curvature of spine associated with other conditions
Acquired spondylolisthesis
805.4 - 805.5
Fracture of vertebral column without mention of spinal cord injury, lumbar
806.4 - 806.5
Fracture of vertebral column with spinal cord injury, lumbar
810.00 - 810.13
Fracture of clavicle (nonunion)
812.00 - 813.93
Fracture of humerus, radius and ulna (nonunion)
815.00 - 815.19
Fracture of metacarpal bone(s) (nonunion)
820.00 - 821.39
Fracture of femur (nonunion)
823.00 - 825.35
Fracture of tibia and fibula, ankle, tarsal and metatarsal (nonunion)
Dislocation of lumbar vertebra, closed
Dislocation of lumbar vertebra, open
Arthrodesis status [nonunion of prior fusion]
ICD-9 codes not covered for indications listed in the CPB:
640.00 - 648.94
Complications mainly related to pregnancy
Personal history of malignant neoplasm
Supervision of pregnancy
Postpartum care
Other ICD-9 codes related to the CPB:
Pathological fracture of neck of femur
Fracture of ilium, closed
Fracture of ilium, open
996.40 - 996.49
Complications of bone grafts
Infection and inflammatory reaction due to other internal orthopedic device, implant, and graft
Complications due to internal orthopedic graft
Other complications of internal (biological) (synthetic) prosthetic device, implant, and graft
InFuse Bone Graft (Bone Morphogenic Protein-2):
ICD-9 codes covered if selection criteria are met:
Degeneration of lumbar or lumbosacral intervertebral disc
Fracture of the tibia and fibula shaft, open [for skeletally mature persons stabilized with intramedullary nail fixation after appropriate wound managememt and applied within 14 days after the initial fracture]
Pro Osteon Hydroxyapatite Bone Graft Substitute:
ICD-9 codes not covered for indications listed in the CPB:
Malignant neoplasm of scapula and long bones of upper limb
Malignant neoplasm of long bones of lower limb
Secondary malignant neoplasm of bone and bone marrow
Benign neoplasm of scapula and long bones of upper limb
Benign neoplasm of long bones of lower limb
Anal fistula
722.4 - 722.73
Degeneration of intervertebral disc
722.80 - 722.83
Postlaminectomy syndrome
733.20 - 733.29
Cyst of bone
Nonunion of fracture
737.0 - 737.9
Curvature of spine
Acquired spondylolisthesis
Certain congenital musculoskeletal deformities of spine
Spondylolysis, lumbosacral region
Other anomalies of spine
805.00 - 805.9
Fracture of vertebral column without mention of spinal cord injury
806.00 - 806.9
Fracture of vertebral column with spinal cord injury
812.44, 813.43, 820.01, 820.11, 821.22
Epiphyseal fractures
839.00 - 839.59
Dislocation of vertebra
Platelet-Rich Plasma:
CPT codes not covered for indications listed in the CPB:
Injection(s), platet rich plasma, any tissue, including image guidance, harvesting and preparation when performed
HCPCS codes covered if selection criteria are met:
Platelet rich plasma, each unit
HCPCS codes not covered for indications listed in the CPB:
Procuren or other growth factor preparation to promote wound healing
ICD-9 codes covered if selection criteria are met:
287.30 - 287.5
Porcine Intestinal Submucous Surgical Mesh:
CPT codes not covered for indications listed in the CPB:
Repair of anorectal fistula with plug (e.g., porcine small intestine submucosa [SIS])
Bone Void Fillers for Nonunions:
HCPCS codes not covered for indications listed in the CPB:
Porous purified collagen matrix bone void filler (Integra Mozaik Osteoconductive Scaffold Putty, Integra OS Osteoconductive Scaffold Putty), per 0.5 cc [actifuse silicate calcium sulphate]
Porous purified collagen matrix bone void filler (Integra Mozaik Osteoconductive Scaffold Strip), per 0.5 cc [actifuse silicate calcium sulphate]
ICD-9 codes not covered for indications listed in the CPB:
Malunion of fracture
Nonunion of fracture
Polymethylmethacrylate (PMMA) Antibiotic beads:
CPT codes covered if selection criteria are met:
Insertion, non-biodegradable drug delivery implant
Removal, non-biodegradable drug delivery implant
Removal with reinsertion, non-biodegradable drug delivery implant
ICD-9 codes covered if selection criteria are met:
730.10 - 730.19
Chronic osteomyelitis [PMMA antibiotic beads are covered when used with IV antibiotics in the treatment of chronic osteomyelitis]
Mesenchymal Stem Cell Therapy/Bone Marrow Aspirate:
CPT codes not covered for indications listed in the CPB:
Bone marrow; aspiration only
Bone marrow harvesting for transplantation; autologous
38240 - 38241
Bone marrow or blood derived peripheral stem cell transplantation
Other CPT codes related to the CPB:
Aspiration and injection for treatment of bone cyst
22548 - 22819
Arthrodesis, spine
HCPCS codes not covered for indications listed in the CPB:
Bone marrow aspiration performed with bone marrow biopsy through the same incision on the same date of service
Cord blood-derived stem-cell transplantation, allogeneic
Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care in the global definition
ICD-9 codes covered if selection criteria are met: :
733.20 - 733.29
Cyst of bone
ICD-9 codes not covered for indications listed in the CPB:
Malunion of fractures
Nonunion of fracture
Arthrodesis status
Tendon Wrap Tendon Protector:
HCPCS codes not covered for indications listed in the CPB:
Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (Tenoglide Tendon Protector Sheet), per square centimeter [Tendon Wrap Tendon Protector]
CDT Codes1
D7921 -- Collection and application of autologous blood concentrate product
The above policy is based on the following references:
American Dental Association. Dental Procedure Codes, CDT 2013 : 73.
Bone Graft Substitutes:
Platelet-Rich Plasma:
Porcine Intestinal Submucosa Surgical Mesh
Bone Void Fillers for Nonunions:
Mesenchymal Stem Cell Therapy:
Miscellaneous Interventions:
Revision Dates
Original policy: July 12, 2012
Revised: August 12, 2013
See Medical Clinical Policy Bulletin 0411 -- Bone and Tendon Graft Substitutes and Adjuncts. Revised 07/30/2013 to state: that bone marrow injections are considered medically necessary in the treatment of bone cysts. This CPB is revised to state that polymethylmethacrylate (PMMA) antibiotic beads are considered medically necessary for use in conjunction with intravenous antibiotics in the treatment of chronic osteomyelitis. This CPB has been revised to state that the following are considered experimental and investigational: Ovation, Regenexx, and Trinity mesenchymal stem cell therapy; gracilis cadaveric graft for hallux valgus repair; human growth factors (e.g., fibroblast growth factor, insulin-like growth factor) to enhance bone healing; Tendon Wrap Protector for tendon repair; bone marrow aspirate for osteoarthritis, and Ligament and Joint Regeneration and Neuvo-generation Medicine (LaJRAN).
Property of Aetna. All rights reserved. Dental Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical/dental advice. This Dental Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating health care professionals are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating health care professionals are solely responsible for medical/dental advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
Copyright 2012 American Dental Association. All rights reserved.
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Environmental Issues > Wildlife Main Page > All Wildlife Documents
Why We Need Bees
Nature's Tiny Workers Put Food on Our Tables
last revised 3/17/2011
Sign up for NRDC's online newsletter
NRDC Gets Top Ratings from the Charity Watchdogs
- Charity Navigator awards NRDC its 4-star top rating.
- Worth magazine named NRDC one of America's 100 best charities.
- NRDC meets the highest standards of the Wise Giving Alliance of the Better Business Bureau.
Switchboard Blogs
- Please Comment on the Montana Wolf Stamp!
- posted by Zack Strong, 8/12/14
- Governor Cuomo Shuts Down the Country's Biggest Ivory Market
- posted by Elly Pepper, 8/11/14
- "Biological impacts of fracking still largely unknown"
- posted by Amy Mall, 8/5/14
Related Stories
- Return of the Black Rhinos
- Namibia's black rhinos are now more valuable alive than dead.
- In the Bay of Whales
- Getting up close and personal with gray whales at Laguna San Ignacio.

subset: commoncrawl


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Kristin Cavallari Celebrates Baby Shower -- and Heidi Montag Resurfaces!
Former star of "The Hills" Kristin Cavallari celebrated her baby shower this weekend, and there was once face present who we've not seen in quite some time...
FTC: Skechers Deceived Consumers With Shoe Ads
The government wants you to know that simply sporting a pair of Skechers' fitness shoes is not going to get you Kim Kardashian's curves or Brooke Burke's toned tush.
Jessica Simpson Gives Birth to a Baby Girl!
The long wait is finally over ... Jessica Simpson is a mom! What do you think of the little one's unusual name?
Tony Romo and Candice Crawford Welcome Baby Boy!
Dallas Cowboys quarterback Tony Romo and wife Candice Crawford have welcomed their first child, a baby boy! What do you think of his name?
Reese Witherspoon Flaunts Baby Bump On the Beach!
Reese Witherspoon has yet to officially confirm that she is pregnant, but it seems her belly certainly seems to be making the announcement for her now!
Alicia Silverstone Feeds Baby Bear from Her Mouth!
Actress Alicia Silverstone reveals that she feeds her son Bear Blu in a unique way -- pre-chewing his food and passing it directly from her mouth to his! Is that ok ... or too bird-like?


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Fun Day Live Music
Primary tabs
Sunday, October 6, 2013 - 1:30 p.m.
Do you like fun music? If so, in celebration of the library's expanded hours, come out to hear saxophonist Robert Martin and keyboardist Marian J. Cole play songs that you know!
Sing-along with us on Sunday Fun Day.


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"Stay hungry, stay foolish"
I love working on new projects and throwing around new ideas! Let me know if you have something fun to work on!
"There Are No Boundaries"
This became my personal mantra while designing the new website for Distinctive Event Productions.
Lewis Medansky has been an event planner in the Phoenix Valley for over 30 years and it was my mission to establish a brand identity for his company by creating a new logo and finally giving him a website that embodies his style and dedication to his craft.
Experiences define our existence, and how someone reacts to your organization's website can affect whether or not you garner their business, donation or support.
I design engaging websites.
I design good-looking websites.
I build highly-functioning websites and I do not believe that you should have to sacrifice user-experience for aesthetics.
I am a sponge when it comes to learning new things and programs. Here are some of the programs that I am fluent in:
It is impossible to fit all of my projects on this one teensy website! I invite you to take a look at my blog to catch up on my latest-and-greatest works, crumbs, tidbits, freebies and tips.


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Another week with great results
Forget about the reasons for the market increase, let's just look at the facts.
Value Line Index -- Contains 1700 stocks so it's much broader than the S&P 500 or the much narrower Dow 30
- Index was up by 2.49% this week -- That make 3 weeks in a row and better yet 3 months in a row
- The Index closed on Friday above its 20, 50 and 100 day moving averages
- Index is up 5.60% in the last 30 days
Barchart's 13 technical indicators all signal a buy for a 100% technical buy rating
Barchart Market Momentum -- contains 6000 stocks -- Percentage of stock closing above their own daily moving averages for various time frames -- Good numbers for all 3 time frames
- 20 DMA -- 71.77% closed above -- 64.69% did last week
- 50 DMA -- 84..82% closed above -- 82.52% did last week
- 100 DMA -- 84.04% closed above -- 81.58% did last week
Ratio of stock hitting new highs to new lows for various time frames -- 1.0+ bullish, 1.0 neutral, below .99 bearish -- Bullish for all 3 time frames
- 20 day new high/new low ratio -- 1520/336 = 4.52
- 65 day new high/new low ratio -- 1082/97 = 11.15
- 100 day new high/new low ratio -- 996/76 = 13.10
Investing Strategy -- All 3 yard sticks gave me very positive vibes. If one of my stocks fails to maintain a price above its 50 DMA I'll cull and replace it. This market seems to have solid legs at the present time.
Wall Street Survivor results -- The columnists for Top Stocks have a little friendly competition over on Wall Street Survivor. This month the S&P 500 has returned 1.87% so far. I'm in first place for the month at 5.15% just slightly ahead of the Motley Fool All Stars with a 2.42% return. John Reese also beat the bench mark with a 2.36% return.
Jim Van Meerten is an investor who write on financial matters here and on Financial Tides. Please leave a comment below or email firstname.lastname@example.com
Disclosure: I do not own positions in the stock contained in my blogs.
Copyright © 2014 Microsoft. All rights reserved.
Fundamental company data and historical chart data provided by Morningstar Inc. Real-time index quotes and delayed quotes supplied by Morningstar Inc. Quotes delayed by up to 15 minutes, except where indicated otherwise. Fund summary, fund performance and dividend data provided by Morningstar Inc. Analyst recommendations provided by Zacks Investment Research. StockScouter data provided by Verus Analytics. IPO data provided by Hoover's Inc. Index membership data provided by Morningstar Inc.
New study finds members of this global elite are stashing an average $600 million each in cash -- 10 times more than a year ago.
Top Stocks provides analysis about the most noteworthy stocks in the market each day, combining some of the best content from around the MSN Money site and the rest of the Web.
Contributors include professional investors and journalists affiliated with MSN Money.
Follow us on Twitter @topstocksmsn.


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1 year ago


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- News
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Thursday, April 18, 2013 - 10:57pm
(CNN) — UPDATE: A university police officer has died after being shot on the Massachusetts Institute of Technology campus in Cambridge late Thursday, according to state police.
A university police officer was shot on the Massachusetts Institute of Technology campus in Cambridge late Thursday and has been taken to a local hospital, state police spokesman Lt. Mark Kiley said.
Police and the FBI responded to reports of gunshots at Building 32, according to MIT, which posted a message on its Twitter account. Officers surrounded and cordoned off the building.
The university, which lies adjacent to the city of Boston, requested people stay away from the building as police consider the situation still active and dangerous.
Residents in the area have been on edge after two bombs ripped through the crowd near the finish line of the Boston Marathon, killing three people and injuring about 180 others.


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You all know the phrase, "gray area", don't you? Well it's been a different kind of grey area around these parts.Ā And there's more rain for today.
Yay. (in massive sarcasm quotes)
{ 5 comments… read them below or add one }
There is beauty in the stark contrast between the gray sky and the trees. You captured it well in this photo. I love these days because they make me contemplative, reflective, and more appreciative of the sunnier days of autumn. Thank you for sharing this photo.
I think your photo is beautiful. I happen to appreciate black and white landscape photography. Have you seen Ansel Adams photos of Yosemite? I believe that he would set up and sometimes wait for long periods of time in order to catch just the right shading and light on his subject. I look forward to your photos because you seem to have a good eye for composition. Keep up the good work!
I try hard not to let gray days affect my mood, but man, I just can't shake it sometimes! I am grateful for beautiful weather today (the sun! oh the sun!). And even more grateful that Turkey Day will be 60 degrees out in Chicago! Yay!
I strongly dislike winter weather! Summer is the season for me!
On the bright side, the photo looks nice, almost like a black and white…only mostly gray. LOL
Leave a Comment
Previous post: I iz the color picker


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First Drive One positive thing to emerge from soaring fuel costs in the summer of 2008 was the American public's willingness to consider alternative fuels. This gave Volkswagen the opportunity to introduce super efficient high mileage diesel engines over here, items that Europeans have held as commonplace for years. What many associate with an SUV, besides the ample seating space, is a large engine with loads of torque. The common side effect of loads of torque from a gas-burning engine, though, is usually poor fuel economy. With the new '09 Touareg TDI, Volkswagen has combined the torque from a gas V8 with fuel economy more readily associated with a four-cylinder.
The Touareg 2 TDI is the second vehicle Volkswagen has released utilizing 50-state-legal clean diesel technologies here in the U.S., and it won't be the last. By the end of 2009, VW will have a total of four diesel models in showrooms including the Jetta, Jetta Sportwagen and the Mk VI Rabbit. With such a variety of models available, VW will make owning a diesel vehicle that fits your needs easy.
The Touareg V6 TDI Clean Diesel is powered by a 3.0-liter turbocharged six cylinder engine that produces 221 hp and an impressive 407 lb-ft of torque starting at 1750 rpm. It is also unique to the U.S. market. Compared to its European counterpart the U.S. version has 19 fewer horses but has more torque at lower rpm. This isn't due to fuel quality or emissions; it's the driving style and demands of the American consumer. Volkswagen engineers found it necessary to reduce the size of the turbocharger to give the engine a power curve more suited to the varying road conditions found in the States. The benefit of using the smaller variable geometry turbo is how fast it spools, helping combat a decrease in low-end response experienced at higher altitudes and allowing the vehicle to produce peak torque at a measly 1750 revs. And while most consumers might not notice, the engineers wanted to make sure even the most discerning drivers would be happy.
Normally you don't associate heavy SUVs with Tier 2, Bin 5/ULEV II low-emissions standards, mainly because the heavier the vehicle, the greater the emissions. What makes the Touareg V6 TDI 50-state legal are major advancements in diesel technology. ADBlue, a 35 percent urea solution, is continuously sprayed into the exhaust stream right before the DeNOx catalyst. As the solution and exhaust gases enter the DeNOx catalyst, a chemical reaction occurs that splits the nitrogen oxides into nitrogen and water, reducing NOx emissions by 90 percent.
The Touareg V6 TDI has also retained and advanced upon the safety features commonly associated with an SUV. It is equipped with a Prevent and Preserve Safety System (PPSS) consisting of more than 45 standard safety features designed to help drivers both avoid and survive a collision. Preservation features include anti-intrusion steel door beams, safety cage unibody construction, six airbags, and three-point safety belts with pretensioners on all outboard seating positions. While surviving a crash is critical, avoiding it is even better, so prevention features include an advanced tire pressure monitoring system, intelligent crash response system, massive four-wheel vented brakes, Electronic Stabilization Program (ESP), Anti-Slip Regulation (ASR), and Anti-lock Braking System. In addition to the long list of standard features, optional HID headlamps and an ultrasonic rear-park assistance system are available to further enhance the PPSS.
The following may seem like an odd comparison, but it makes a point about the performance characteristics of the Touareg V6 TDI. From a dead stop, if you were to go head-to-head with a 2009 Jetta 2.5L automatic, from zero to 60 mph you'd be more or less dead even with an elapsed time of 8.5 seconds. The Touareg TDI's sprinting ability is quite impressive considering its 2,000-pound weight disadvantage.
Having owned a 2004 Touareg V6, I've always loved the duality of the vehicle's nature. Equipped with the standard spring steel suspension it was an amazing road-going vehicle with exceptional off-road capabilities. A new feature seen in the 2009 Touareg V6 TDI, called Comfort Suspension, changes the Touareg's driving characteristics-and not necessarily in a good way. While going in a straight line at low speeds it was fine, but as soon as I got up to speed or hit a corner the confident handling that I remembered from driving my '04 was quickly replaced with apprehension and the desire slow down. For the average soccer mom driver the suspension will offer comfort and stability. If you're more performance-minded like moi, opt for the four-corner air suspension or upgraded coil springs with a stiffer suspension and increased handling.
Having driven every variation of the Touareg available besides the V10 TDI, the V6 TDI engine is by far the most promising configuration to date. It's quieter than the VR6 gas engine, has more torque, and most importantly gets much better gas mileage. Volkswagen only expects 15 to 20 percent of Touareg sales to be the V6 TDI, but hopefully the American people can disprove those low estimates. The real hurdle might be keeping the TDIs in stock so consumers have the chance to experience it, because in order to understand it, you have to drive it.
And for those worried that the diesel engine needs more upkeep than the gas engine, the Touareg V6 TDI comes with a no charge Carefree Maintenance Program that covers all the scheduled maintenance including the ADBlue solution for 3 years or 36,000 miles.
2009 Volkswagen Touareg V6 TDI * LayoutLongitudinal front engine, all-wheel drive
* Engine3.0-liter V6, dohc, 24-valve,turbocharged and intercooled
* TransmissionSix-speed automatic
* SuspensioIndependent front and rear
* BrakesVented front and rear discs
* DimensionsLength/Width/Height (in.):187.2/75.9/68.0Wheelbase: 112.4 in.Curb Weight: TBA
* PerformancePeak Power: 221 hpPeak Torque: 407 lb-ft @ 1750 rpm 0-62 mph: 8.5 sec.Top Speed: 130 mph
Price Tag$TBA


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- Sam Ash Gift Guides
- Hot Deals
- Guitars
- Bass
- Accessories
- Live Sound
- Keyboards
- Microphones & Wireless
- Recording
- DJ & Lighting
- Drums
- Books/DVDs
- Band/Orchestra
To automatically re-order this item before you run out, select the recurring order option during checkout.
LP Pro Maracas are the most imitated maracas around. They are offered in matched pairs of one high pitch and one low pitch. This variation in pitch is the way maracas were historically designed to produce the classic maraca sound.
Although traditionally a Latin instrument, these maracas are used in all styles of music to cut through live performances.
LP Pro Maracas feature bright, loud sound with vibrant yellow, plastic shells and wood handles.
|LP281 Pro Maracas
LP281 Pro Maracas
3 Years on LP and Matador shells, stands, hardware, 90 Days on bags and cases 2 Years on all other brands


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"Men in Black 3" successfully opens as the North American box office champion on Memorial Day weekend. Dethroning "The Avengers" from the top spot, the action comedy movie grosses $55 million in its initial week of release. Overseas, the film has collected $132 million, fueled by strong performance in Russia and Asia.
After ruling the chart for three weeks in a row, the Earth's Mightiest Heroes movie falls one position to the runner-up spot. The Marvel superhero film takes in $36.7 million, dropping 34% from last week. The star-studded pic already crossed its $500 million mark on its 23rd day of release on Saturday, beating "Avatar" which took 32 days to achieve the same milestone in 2009.
Landing on the third place is "Battleship" which rakes in $10.9 million. Dropping 58%, the Hasbro movie bags a total domestic cume of $44.3 million after two weeks playing in theaters across the United States. "The Dictator", meanwhile, secures the fourth place with $9.2 million, falling 45% from last week. The Sacha Baron Cohen-starring mockumentary grabs a total cume of $41.4 million in its second week.
Rounding up the top five is newcomer "Chernobyl Diaries". The Jesse McCartney-starring horror movie earns $7.9 million. Earning a dismal "D+" CinemaScore, the low-budgeted film performs under Warner Bros. Pictures' expectation which predicted it would gross at least $9.4 million on its debut weekend.
Top Ten Movies at Box Office for May 25-27:
© AceShowbiz.com


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Chocolate Lovers Weekend
Treat the Chocolate Lover in your life to a Weekend of Decadence! Hideaway Country Inn, Mid Ohio's premiere Bed and Breakfast is sure to tantalize the senses of your Chocolate Lover!
This decadent package includes two chocolate scented fizzmos for your Jacuzzi, Eat Chocolate Naked fondue with melted chocolate, dipping treats, assorted dipped chocolates and two mini paintbrushes for your creative enjoyment. A relaxing one hour couples massage with chocolate scented massage oil. A private candlelight dinner for two, including chocolate lava cake for dessert on your second night's stay, and an intimate picnic basket dinner delivered to your suite the first night with chocolate mousse for dessert!
After this romantic, pampering and indulgent weekend with your lover, you'll never again look at chocolate the same!
Add $450.00 to any suite of your choice.
Package amenities can be customized. Book here for your indulgent and romantic chocolate lover's Mid Ohio's Premiere Bed and Breakfast weekend getaway!
Upcoming Events
Sep 19
Downtown Marion Market4:00 pm - 7:00 pm
Sep 20
Travel Through Time @ Sawyer Ludwig Park11:00 am - 4:00 am
Sep 24
Kingwood Center9:00 am - 7:00 pm


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I recently joined my friend (who is a DJ), at one of his gigs at a well known British Bar. He asked if I could take some photos of him, his DJ partner and the venue. He also asked if I could not use a flash as this may put them off of their mixing etc.
At first I thought "take photos in a dark room without a flash, you cant do that!". It turns out, you can…..
I read a few articles which covered taking photos in clubs and bars where the light is dim but you need to capture images using a fairly fast shutter speed, they all pretty much had the same advice;
- Open up – F3 or higher (the higher the better!)
- ISO set as high as possible…1600 or above
- Use a flash!
I had the first 2 covered, my lens allowed me to go up to F2.8 and my ISO will go to 3200 (suprisingly without too much noise!). It was the third 'rule' that worried me, 'use a flash', I can't though!?
Get there early
Firstly, when we turned up, because it was quite early and in the summer months there was still quite a lot of natural light from the large windows, this helped and I was able to get some good HDR shots of the venue. As it was ealry it also helped that the bar was quiet and I could get three exposures without too much movement from the people in the bar.
The DJ (subject) Preparing
Next I went back to the DJ area where my friend was setting up. This was the perfect opportunity to take some shots in good light, without too much background distraction and before he started to bounce around to his tracks. I tried to get an original angle and decided to take the photos from behind the DJ of him checking the equipment.
Mix It Up A Bit
Because I wanted to show the different styles that could be used to allow my friend to choose a preference for the next gig (if he had a preference), I took some shots in black and white, colour, HDR, slow shutter, with a Star or Zoom Burst filter etc etc. This meant that if he didn't like a particular style of photo, he would be able to choose another one rather than feel that none of the photos were what he was looking for. Remember, the more types of photos you take, the more chance that one or two of them will fit the tastes of the person that you are taking them for.
Different Perspective
One thing I tried to do was to get a different perspective on a couple of shots. For this I chose to take a picture of the DJ with his headphones on (typical image you think of about a DJ).
No Flash, Use the Available Light
One of the best lessons that I leanrt about taking photos in low light without a flash was how to use the light available at the location. The lights within the club (every club should have these!) helped greatly and using a Star filter I was able to make them part of the photo rather than just a part of the background.
I did have issues taking close up shots where there was no light within shot but I got around this by zooming out and then cropping in post production (is that cheating?!).
What's Occuring?
One thing that I found very useful was talking to one of the DJ's about the order in which things happen. On his particular night they were taking it in turns to play. I learned that the best time to get shots of the DJ with his headphones on or mixing was between tracks and I could tell when this would be by the laptop timer etc. This was very useful for the future and is another option available to me for future shots.
Tips I used that worked
Other than high ISO (although see how low you can go and get away with, DO NOT assume you need to whack it straight up to the highest!) and opening up;
- Talk to the person that you are there to shoot, they will have experience of the situation and know when certain events happen that may make a great shot.
- Get to the venue early, firstly to set up, but also to get some shots while its quiet.
- Take LOADS of shots, I took 400 photo's in about 3 hours!
- Be confident and introduce yourself to Staff/Managers etc
- Ask questions about what your subject is doing, the more you know the better your photos will be.
- Mix up styles and angles and use different filter etc
- Take spares (batteries, memory card etc)
- Watch your kit, leave it safe and keep your camera on you!
What I learned for next time
- Take a flash next time (just in case)
- Take a step ladder (if allowed) for overhead shots etc
Lastly, if you need a superb DJ/DJ's then check out 4-DJ and VITRO.