A prospective randomized comparison of rectangular titanium cage fusion and iliac crest autograft fusion in patients undergoing anterior cervical discectomy. Rigid fusion after cloward operation for cervical disc disease using autograft, allograft, or xenograft: a randomized study with radiostereometric and clinical follow-up assessment. Autograft versus interbody fusion cage without plate fixation in the cervical spine: a randomized clinical study using radiostereometry. A randomized prospective study of an anterior cervical interbody fusion device with a minimum of 2 years of follow-up results. A prospective, randomized controlled clinical trial of anterior lumbar interbody fusion using a titanium cylindrical threaded fusion device. A prospective randomized comparison between the cloward procedure and a carbon fiber cage in the cervical spine: a clinical and radiologic study. Radiographic analysis of fusion progression following one-level cervical fusion with or without plate fixation. Comparison of anterior cervical fusions using autogenous bone graft obtained from the cervical vertebrae to the modified Smith-Robinson technique. Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up. Circumferential lumbar spinal fusion with Brantigan cage versus posterolateral fusion with titanium Cotrel-Dubousset instrumentation: a prospective, randomized clinical study of 146 patients. Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study. Anterior cervical fusion with tantalum implant: a prospective randomized controlled study. A prospective randomized comparison of coralline hydroxyapatite with autograft in cervical interbody fusion. Anterior cervical microdiscectomy with or without fusion. The ProDisc-C prosthesis: clinical and radiological experience 1 year after surgery. Discectomy versus discectomy with fusion versus discectomy with fusion and instrumentation: a prospective randomized study. Anterior cervical fusion with interbody cage containing beta-tricalcium phosphate augmented with plate fixation: a prospective randomized study with 2-year follow-up. Comparative evaluation of microdiscectomy only, autograft fusion, polymethylmethacrylate interposition, and threaded titanium cage fusion for treatment of single-level cervical disc disease: a prospective randomized study in 125 patients. A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate. A prospective randomized study comparing a cervical carbon fiber cage to the Smith-Robinson technique with allograft and plating: up to 24 months follow-up. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. The role of fusion and instrumentation in the treatment of degenerative spondylolisthesis with spinal stenosis. PMMA versus titanium cage after anterior cervical discectomy - a prospective randomized trial. Outcome of the Graf ligamentoplasty procedure compared with anterior lumbar interbody fusion with the Hartshill horseshoe cage. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. A prospective, randomized, double-blind study of the efficacy of postoperative continuous local anesthetic infusion at the iliac crest bone graft site after posterior spinal arthrodesis: a minimum of 4-year follow-up. Choice of plate may affect outcomes for single versus multilevel ACDF: results of a prospective randomized single-blind trial. Biocompatible osteoconductive polymer versus iliac graft. A prospective comparative study for the evaluation of fusion pattern after anterior cervical discectomy. Fusion and failure following anterior cervical plating with dynamic or rigid plates: 6-months results of a multi-centric, prospective, randomized, controlled study. Lumbar disc arthroplasty with Maverick disc versus stand-alone interbody fusion: a prospective, randomized, controlled, multicenter investigational device exemption trial. A prospective, randomized study of lumbar fusion. Preliminary results. Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial.
The authors compare clinical outcome and fusion rates after iliac crest autograft (ICAG)- and rectangular titanium cage (RTC)-augmented fusion in patients undergoing anterior cervical discectomy (ACD).
                One hundred consecutive patients with 127 levels of cervical disc disease refractory to conservative treatment were randomized into one of the two treatment groups (ICAG/RTC fusion). The visual analog scale was used by the patient to rate overall pain and head, neck, arm, and donor site pain separately. Myelopathy was documented according to Japanese Orthopaedic Association and Nurick grading systems. Outcome was analyzed using Odom criteria, the 36-Item Short Form (SF-36), and Patient Satisfaction Index scales. Fusion rates were assessed on standard and flexion-extension radiographs. Follow-up data of at least 12 months' duration were available for 95 patients. More residual overall pain after 12 months was documented in patients who underwent ICAG fusion (3.3 +/- 2.5 [ICAG] and 2.2 +/- 2.4 [RTC]; p < 0.05). Although arm and head pain were minimal in both groups, neck pain proved to be the predominant symptom (2.7 +/- 2.5 [ICAG] and 1.9 +/- 2.1 [RTC]), which resolved in only 67 and 48% of RTC- and ICAG-treated patients, respectively (p < 0.05). Myelopathy improved comparably in both groups. Regardless of increased pain in ICAG-treated patients, PSI and SF-36 scores were not significantly different between groups (only four [8%] of 47 ICAG-treated patients and five [10%] of 48 RTC-treated patients were unsatisfied). Good to excellent functional recovery according to Odom criteria was observed in 75 and 79% of ICAG- and RTC-treated patients, respectively. Fusion rates were 81 and 74%, respectively (p = 0.51).
                Fusion rates and clinical outcome at 12 months after ACD were comparable between patients who underwent ICAG and RTC fusion. The use of rectangular cages, however, avoids donor site morbidity and reduces overall pain and, thus, seems to be an advantageous treatment alternative. In this study, 43 patients scheduled for a single-level cervical Cloward procedure for disc disease were randomized prospectively to fusion with autograft, allograft, or xenograft.
                To outline any differences in fusion over time in terms of final mobility and clinical outcome between the three bone grafts.
                Fusion is used to relieve pain from a spinal segment. The bovine xenograft gives a fibrous fusion in contrast to the solid bone fusion obtained with autograft from the iliac crest, but no definite differences in clinical outcome have been shown previously after surgery at a single level.
                By use of radiostereometric analysis, 33 patients were observed after 6, 12, and 24 to 50 (mean, 37) months. All 43 patients underwent clinical examination, which involved pain rating before and after surgery, with a final follow-up assessment by an unbiased observer.
                Mobility could be demonstrated in 9 patients after 1 year and in 6 patients at the final follow-up assessment, without pain, and with no difference between bone grafts. The patients who received autograft experienced a greater reduction of pain than the patients treated with xenograft.
                Most of the patients healed with a rigid fusion no matter which graft was used, but the healing process took longer than expected. The clinical results were not influenced by whether mobility could be demonstrated. There was a tendency toward better clinical results in the patients treated with autograft. A primary object with a fusion cage is avoidance of graft collapse with subsequent subsidence and malalignment of the cervical spine that is observed after bone grafting alone. No randomized studies exist that demonstrate the difference between these two methods in terms of graft subsidence and angulation of the fused segment. The size of the study population was calculated to be 24 patients to reach a significant difference at the 95% CI level. Patients with one-level cervical radiculopathy scheduled for surgery were randomized to anterior discectomy and fusion (ACDF) with autograft or to fusion cage, both without plate fixation. Tantalum markers were inserted in the two adjacent vertebrae at the end of surgery. Radiostereometry was performed immediately postoperatively and at regular intervals for 2 years. Questionnaires were used to evaluate the clinical outcome and an unbiased observer graded the outcome after 2 years. No significant differences were found between the two methods after 2 years in regard of narrowing of the disc space (mean 1.7 and 1.4 mm, respectively) or deformation of the fused segment into flexion (mean 7.7 degrees and 4.6 degrees , respectively). Patients in the cage group had a significantly better clinical outcome. The findings of subsidence and flexion deformation of the fused segment after 2 years seem to be of no clinical importance after one-level cervical disc surgery. However, in multi-level surgery using the same methods, an additive effect of the deformations of the fused segments may affect the clinical outcome. Despite variations in technique, inherent problems persist with current approaches to anterior cervical fusion. This study was performed to determine whether anterior cervical fusion performed using an investigational device was safe and effective in the treatment of degenerative cervical disc disorders and whether this device offered advantages over current techniques.
                Fifty-four patients with radiculopathy with or without mild myelopathy due to one- or two-level cervical degenerative disc disease were randomized as part of a Food and Drug Administration device study. Following microsurgical discectomy, the control group was treated with iliac crest graft fusion; the experimental study group underwent insertion of an interspace cage and placement of a local autograft. All patients received postoperative follow-up care for at least 2 years. Good or excellent results were found in approximately 97% of the experimental group and 88% of the control group. A solid fusion was achieved in all patients who underwent one-level cage placement, and a solid fusion at one or both levels was achieved in over 90% of both groups. Chronic donor site pain was reported by 31% of the control group.
                In this study, the use of an interbody fusion cage avoided donor site morbidity and placement of autograft achieved a high rate of good or excellent results. Interbody fusion cages appear safe and effective, and their use helps to avoid some of the inherent problems in performing current anterior cervical fusion techniques. A prospective, randomized, controlled clinical trial comparing a cylindrical threaded titanium cage to a femoral ring allograft control for anterior lumbar interbody fusion.
                To compare these two implants with regard to arthrodesis. Secondary outcome measures included pain relief, neurological status, and general health status.
                Anterior lumbar interbody fusion is a well-accepted procedure using trapezoidal femoral ring allografts or cylindrical titanium cages. Clinical and biomechanical studies evaluating these two distinct constructs are numerous; however, no prospective, randomized study comparing them has been done.
                A multicenter trial of 140 patients: 78 were randomized to the cylindrical threaded titanium cage device treatment arm and 62 patients randomized into the control group. All had autogenous iliac crest bone graft packed into the device. All patients had a single-level stand-alone anterior lumbar interbody fusion at either the L4-L5 or L5-S1 interspace for symptomatic degenerative disc disease. Radiographic fusion data were collected as well as multiple types of outcome data, including pain/disability scores, neurologic status, and overall health.
                At 12 months, 97% of the cylindrical threaded titanium cage device group and 40% of the control group demonstrated radiographic fusion. At 24 months, 97% of the cylindrical threaded titanium cage group and 52% of the control group showed radiographic fusion. These fusion rate differences are statistically significant (P < 0.001). The Oswestry and neurologic scores were not significantly different between groups.
                This is the first prospective, randomized, multicenter clinical trial that compares fusion cage results to control data.
                Cylindrical threaded titanium cages have a higher fusion rate, comparable improvements in clinical outcome (Oswestry, Low Back Pain Questionnaire, SF-36), and fewer secondary supplemental fixation procedures compared to the femoral ring allograft control. A prospective randomized study was conducted.
                To determine whether the use of a cervical carbon fiber intervertebral fusion cage improves the outcome of anterior cervical decompression and fusion, as compared with the Cloward procedure using autograft.
                Despite the theoretical advantages of using intervertebral cages, including reduced donor site morbidity and prevention of graft collapse, an improved clinical outcome has not yet been documented.
                For this study, 103 patients were randomized to anterior cervical decompression and fusion with a carbon fiber intervertebral fusion cage (n = 52) or the Cloward procedure (n = 51). An independent observer quantified pain and functional disability. Fusion rate, segmental kyphosis, and disc height were assessed by radiographs.
                During a mean follow-up period of 36 months (range, 24-72 months) for 89 patients (86%), the pain and disability were similar for both treatments. Postoperative donor site pain was significantly less in the carbon fiber intervertebral fusion cage group. The fusion rate was 86% in the Cloward procedure group and 62% in the carbon fiber intervertebral fusion cage group (P < 0.05). In the latter group, patients with pseudarthrosis reported more severe pain than fused patients (51 and 33 visual analog scores, respectively), but the difference was not significant. The segmental kyphosis was less and the disc height increased in the carbon fiber intervertebral fusion cage group, as compared with the Cloward procedure group. Disc height was not correlated with outcome. Segmental kyphosis showed a weak (r = -0.3) but significant (P < 0.05) correlation with improvement of the Cervical Spine Functional Score, but not with other outcome variables.
                Except for reduced donor site pain, the clinical outcome for the carbon fiber intervertebral fusion cage is the same as for the Cloward procedure. Use of the cage results in a more lordotic alignment and an increased disc height, but in a higher pseudarthrosis rate than use of the Cloward procedure. Anterior cervical discectomy and fusion (ACDF) using bone graft or a cage with plate fixation is an accepted technique for the treatment of symptomatic degenerative disc disease. It is, however, debatable whether a plate is really necessary to increase the progress of fusion. Thus, the aim of this randomized and controlled prospective study was to evaluate whether ACDF with a cage and anterior plate fixation results in a greater progress of fusion compared with ACDF using a stand-alone cage.
                37 candidates for ACDF were treated either with a stand-alone cage (study group) or with a cage+plate fixation (control group). 19 patients were randomized to be stabilized with a stand-alone cage and 18 patients were treated with a cage and additional anterior plate fixation. The progress of cervical fusion over time was compared by radiostereometric analysis (RSA). Follow-up examinations pre- and postoperatively were done using the Visual Analogue Scale (VAS) for neck and arm pain. Radiographic assessment of fusion using an RSA-control was done after one, six and twelve weeks, as well as after six months, and one and two years postoperatively. Mann-Whitney test for unpaired values was used to determine the statistical differences in residual intervertebral motion.
                Three-dimensional analysis of segmental motion (left-right, cranio-caudal, and posterior-anterior) did not reveal any statistical differences between both groups at any examination time postoperatively ( P>0.05). The VAS score did not differ between the groups ( P>0.05).
                Anterior plate fixation did not demonstrate an improvement in the progress of fusion in one-level ACDF. Anterior cervical discectomy and interbody grafting provide excellent results in treating cervical radiculopathy. This prospective study compares the results of the technique obtaining autogenous bone from the cervical vertebrae for grafting to the modified Smith-Robinson technique using autogenous iliac crest graft. Seven levels in six patients were fused using the vertebral body autograft technique and 43 levels in 40 patients using the standard technique. All patients had radiculopathy and neck pain. Statistically significant differences in fusion rate (4/7 vertebral body autograft; 40/43 modified Smith-Robinson) (p = 0.029), disc height maintenance (p = 0.001), and neck pain improvement (p = 0.05) occurred between the techniques. We do not recommend vertebral body autograft over the modified Smith-Robinson technique for anterior cervical fusion following discectomy. A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal (TM) to the traditional Smith-Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. Trabecular Metal is a porous tantalum biomaterial with structure and mechanical properties similar to that of trabecular bone and with proven osteoconductivity. As much as 80 consecutive patients planned for ACDF were randomized for fusion with either TM or tricortical autograft from the iliac crest (SR) after discectomy and decompression. Digitized plain radiographic images of 78 (98%) patients were obtained preoperatively and at 2-year follow-up and were subsequently evaluated by two senior radiologists. Fusion/non-fusion was classified by visual evaluation of the A-P and lateral views in forced flexion/extension of the cervical spine and by measuring the mobility between the fused vertebrae. MRI of 20 TM cases at 2 years was successfully used to assess the decompression of the neural structures, but was not helpful in determining fusion/non-fusion. Pain intensity in the neck, arms and pelvis/hip were rated by patients on a visual analog scale (VAS) and neck function was rated using the Neck Disability Index (NDI) the day before surgery and 4, 12 and 24 months postoperatively. Follow-ups at 12 and 24 months were performed by an unbiased observer, when patients also assessed their global outcome. Fusion rate in the SR group was 92%, and in the TM group 69% (P < 0.05). The accuracy of the measurements was calculated to be 2.4 degrees . Operating time was shorter for fusion with TM compared with autograft; mean times were 100 min (SD 18) and 123 min (SD 23), respectively (P = 0.001). The patients' global assessments of their neck and arm symptoms 2 years postoperatively for the TM group were rated as 79% much better or better after fusion with TM and 75% using autograft. Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1 year for the TM group. There was no statistically significant difference in clinical outcomes between fusion techniques or between patients who appeared radiologically fused or non-fused. There was no difference in pelvic/hip pain between patients operated on with or without autograft. In our study, Trabecular Metal showed a lower fusion rate than the Smith-Robinson technique with autograft after single-level anterior cervical fusion without plating. There was no difference in clinical outcomes between the groups. The operative time was shorter with Trabecular Metal implants. A prospective randomized clinical study with a 2-year follow-up period was conducted.
                To analyze the effects of circumferential fusion using ALIF radiolucent carbon fiber cages and titanium posterior instrumentation on functional outcome, fusion rate, complications, and lumbar lordosis.
                Circumferential fusion has become a common procedure in lumbar spine fusion, both as a primary and salvage procedure. However, the claimed advantages of ALIF plus PLF over conventional PLF lack scientific documentation.
                From April 1996 through November 1999, a total of 148 patients with severe chronic low back pain were randomly selected for either posterolateral lumbar fusion with titanium CD-Horizon (posterolateral group) or circumferential fusion with a ALIF Brantigan cage plus posterior instrumentation. The Dallas Pain Questionnaire (DPQ), the Low Back Pain Rating Scale (LBPR), and a questionnaire concerning work status assessed their outcomes.
                Both groups showed highly significant improvement in all four categories of life quality (DPQ) as well as in the back pain and leg pain index (LBPR), as compared with preoperative status. There was a clear tendency toward better overall functional outcome for patients with the circumferential procedure ( < 0.08), and this patient group also showed significantly less leg pain at the 1-year follow-up evaluation ( < 0.03) and less peak back pain at 2 years ( < 0.04). Sagittal lordosis was restored and maintained in the circumferential group ( < 0.01). The circumferential fusion patients showed a higher posterolateral fusion rate (92%) than the posterolateral group (80%)( < 0.04). The repeat operation rate including implant removal was significantly lower in the circumferential group (7%) ( < 0.009) than in the posterolateral group (22%).
                Circumferential lumbar fusion restored lordosis, provided a higher union rate with significantly fewer repeat operations, showed a tendency toward better functional outcome, and resulted in less peak back pain and leg pain than instrumented posterolateral fusion. The clinical perspective of the current study implies a recommendation to favor circumferential fusion as a definitive surgical procedure in complex lumbar pathology involving major instability, flatback, and previous disc surgery in younger patients, as compared with posterolateral fusion with pedicle screws alone. A prospective randomized clinical study.
                To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage.
                Although an interbody fusion after anterior decompressive surgery for hard or soft disc herniation is widely accepted, there is no scientific evidence that convincingly demonstrates that insertion of graft material for interbody fusion is necessary after discectomy and decompression of the nervous elements have been performed. To date, no randomized studies have compared simple discectomy with discectomy followed by an interbody fusion with a titanium cage.
                Eighty-six patients with symptoms of nerve root compression at 1 level were randomly allocated to either discectomy followed by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery.
                There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain in the neck and arm. Two years after the operation, 86.1% of the patients treated with cage stated a good outcome versus 76.7% in the discectomy group (P = 0.44). The rate of fusion was 83.3% in the cage group versus 81.0% in the discectomy group (P = 0.30). Furthermore, after 2 years, also the rates of new adjacent disc degeneration or spondylosis were the same in both groups.
                This study showed no statistically significant difference between simple discectomy and discectomy followed by interbody fusion with a titanium cage in the surgical treatment of cervical radiculopathy caused by disc herniation. A prospective randomized controlled study was carried out.
                To determine the effectiveness and safety of a tantalum implant in achieving anterior cervical fusion following 1-level discectomy as treatment of degenerative cervical disc disease with radiculopathy.
                The gold standard for the treatment of degenerative cervical disc disease could not be already identified. The morbidity of autologous graft and plating, and the doubt about the mechanical efficacy of plate fixation and the clinical benefits in 1-level fusion have promoted the use of other constructs.
                Sixty-one patients were randomized to anterior cervical discectomy and fusion with interbody implant of tantalum (n = 28) or by means of autologous iliac bone graft and plating (n = 33). Fusion rate and segmental height and alignment were blind assessed by radiographs by 2 independent reviewers. Clinical status was evaluated using pain visual analogue scale, the Neck Disability Index, and the Zung Depression Scale. Patient's subjective satisfaction was recorded. Complications and operative parameters were also taken into account.
                With an endpoint of 24 months, radiologic and clinical outcomes were similar for both treatments without significant difference. The safety of fusion with tantalum implant was obvious, based on the analysis of complications. Complication rate was considerably higher for the autologous graft plus plating procedure than for implant tantalum (P < 0.005).
                The efficacy to achieve fusion after 1-level anterior cervical discectomy, with a good radiologic and clinical outcome, using tantalum implant is equivalent to that of autologous graft and anterior plate, being safer as avoids donor-site graft harvesting and plating complications. A prospective randomized trial with independent clinical and radiographic outcome review of patients receiving either hydroxyapatite or tricortical iliac crest graft for cervical interbody fusion was conducted.
                To determine whether coralline-derived hydroxyapatite is a suitable bone graft substitute in cervical interbody fusion.
                Tricortical iliac crest bone is the "gold standard" graft material for cervical interbody fusion. Various bone substitutes have been used for this procedure to avoid potential donor site morbidity. ProOsteon 200 is a coralline-derived hydroxyapatite product, the use of which remains unclear for cervical interbody fusion.
                In this study, 29 patients undergoing anterior cervical fusion and plating were randomized to receive either ProOsteon 200 or iliac crest grafts. The SF-36 and Oswestry Disability Index were used to measure clinical outcome. Postoperative radiographs were analyzed for graft fragmentation, loss of height, angular alignment, and hardware failure to assess structural integrity of the graft material. Plain radiographs and computed tomography scans were used to evaluate fusion.
                Both the ProOsteon 200 and iliac crest groups demonstrated significant improvement in clinical outcome scores. There was no significant difference in clinical outcome or fusion rates between the two groups. Graft fragmentation occurred in 89% of the hydroxyapatite grafts and 11% of the autografts (P = 0.001). Significant graft settling occurred in 50% of the hydroxyapatite grafts, as compared with 11% of the autografts (P = 0. 009). One patient in the ProOsteon 200 group required revision surgery for graft failure.
                ProOsteon 200 does not possess adequate structural integrity to resist axial loading and maintain disc height or segmental lordosis during cervical interbody fusion. Anterior cervical microdiscectomy (ACD) is commonly applied in the surgical treatment of cervical disc herniation. However, following discectomy procedure to perform a fusion process is still controversial. Therefore, a controlled, multicentric, prospective, randomized study was designed.
                Totally 20 patients were operated. Eleven patients were operated with applying simple anterior microdiscectomy technique. Nine patients were operated via ACD and fusion with a semirigid plate technique. Preoperative and postoperative [immediate; postoperative first day and postoperative 1 y (mean 13.95 mo)] computed tomography studies and plain x-rays were obtained. The cervical disc and bilateral neural foramen heights of the operated level and adjacent segments were calculated. Pain assessment was performed using visual analog pain scale. Mann-Whitney statistical analysis method was applied to compare the outcomes for both groups.
                Satisfactory result was achieved in both groups. The pain scores for major complaint (arm pain) were decreased significantly in all patients after surgery regardless of the type of technique applied. The improvement in neck pain scores was significant only in patients who were treated with fusion procedure. There were no significant changes in disc height and neural foramen height measurements for both groups in adjacent levels in immediate and 1-year postoperative periods. The patients who were operated with simple ACD technique showed no significant decrease at postoperative first day in disc height and neural foramen height. However, the 1-year postoperative radiologic studies showed a significant decrease in disc height and neural foramen dimensions compared with preoperative values. The patients who were treated with fusion process showed a significant increase in disc height and nonsignificant increase in neural foramen heights at immediate postoperative study. However, with time, all dimensions showed significant decrease compared with preoperative values.
                ACD technique offers satisfactory outcome regardless of whether fusion process is applied or not. Fusion with semirigid plate offers an advantage at operated level in immediate postoperative period in regard of disc height and neural foramen height. However, semirigid anterior plates by definition do not stop subsidence and the advantage that is offered by this technique is not persistent. On the other hand, to apply fusion process with semirigid plate system offers significantly less narrowing in disc height compared with simple ACD technique. This is a prospective randomized and controlled study, approved by the local ethical committee of Saarland (Germany).
                The aim of the current study was to analyze segmental motion following artificial disc replacement using disc prosthesis over 1 year. A second aim was to compare both segmental motion as well as clinical result to the current gold standard (anterior cervical discectomy and fusion [ACDF]).
                ACDF may be considered to be the gold standard for treatment of symptomatic degenerative disc disease within the cervical spine. However, fusion may result in progressive degeneration of the adjacent segments. Therefore, disc arthroplasty has been introduced. Among these, artificial disc replacement seems to be promising. However, segmental motion should be preserved. This, again, is very difficult to judge and has not yet been proven.
                A total of 49 patients with cervical disc herniation were enrolled and assigned to either study group (receiving a disc prosthesis) or control group (receiving ACDF, using a cage with bone graft and an anterior plate). Roentgen stereometric analysis (RSA) was used to quantify intervertebral motion immediately as well as 3, 6, 12, 24, and 52 weeks after surgery. Also, clinical results were judged using visual analog scale and neuro-examination at even RSA follow-up.
                Cervical spine segmental motion decreased over time in the presence of disc prosthesis or fusion device. However, the loss segmental motion is significantly higher in the fusion group, when looked at 3, 6, 12, 24, and 52 weeks after surgery. We observed significant pain reduction in neck and arm after surgery, without significant difference between both groups.
                Cervical spine disc prosthesis remains cervical spine segmental motion within the first 1 year after surgery. The clinical results are the same when compared with the early results following ACDF. The need for interbody fusion after anterior cervical discectomy for radiculopathy remains controversial. The purpose of this study was to assess clinical and radiographic outcomes in patients with cervical radiculopathy after discectomy without fusion (ACD), discectomy with intervertebral fusion (ACDF), and discectomy with intervertebral fusion and instrumentation (ACDFI).
                Forty-two consecutive patients with cervical radiculopathy who failed medical management were randomized to one of three treatment groups: ACD, ACDF, or ACDFI. Indices including symptoms, work status, Short Form-36, McGill pain scores, and anteroposterior/lateral flexion/extension x-rays were obtained preoperatively and during the follow-up period.
                There were no inter-group differences observed during the 2-year follow-up period with respect to neck pain, interscapular pain, or arm pain (P > 0.05). Short Form-36 scores demonstrated a dramatic postoperative improvement followed by further gradual improvement in both physical and mental components as well as other subscale scores in all groups during the follow-up period (P < 0.05). Fusion occurred in 67% of the ACD patients compared with 93% of the ACDF patients and 100% of the ACDFI patients (P < 0.05). Segmental kyphosis was noted in 75% of the ACD patients postoperatively compared with 17% preoperatively. There was no change in sagittal balance in the ACDF or ACDFI groups (P > 0.05).
                Patient selection and surgical decompression remain the key to achieving desirable clinical outcomes after cervical discectomy for radiculopathy. Within a 2-year follow-up period, the technique of reconstruction plays no role in clinical results. However, ACD alone results in segmental kyphosis compared with ACDF and ACDFI. A variety of bone graft substitutes, interbody cages, and anterior plates have been used in cervical interbody fusion, but no controlled study was conducted on the clinical performance of beta-tricalcium phosphate (beta-TCP) and the effect of supplemented anterior plate fixation. The objective of this prospective, randomized clinical study was to evaluate the effectiveness of implanting interbody fusion cage containing beta-TCP for the treatment of cervical radiculopathy and/or myelopathy, and the fusion rates and outcomes in patients with or without randomly assigned plate fixation. Sixty-two patients with cervical radiculopathy and/or myelopathy due to soft disc herniation or spondylosis were treated with one- or two-level discectomy and fusion with interbody cages containing beta-TCP. They were randomly assigned to receive supplemented anterior plate (n = 33) or not (n = 29). The patients were followed up for 2 years postoperatively. The radiological and clinical outcomes were assessed during a 2-year follow-up. The results showed that the fusion rate (75.0%) 3 months after surgery in patients treated without anterior cervical plating was significantly lower than that (97.9%) with plate fixation (P < 0.05), but successful bone fusion was achieved in all patients of both groups at 6-month follow-up assessment. Patients treated without anterior plate fixation had 11 of 52 (19.2%) cage subsidence at last follow-up. No difference (P > 0.05) was found regarding improvement in spinal curvature as well as neck and arm pain, and recovery rate of JOA score at all time intervals between the two groups. Based on the findings of this study, interbody fusion cage containing beta-TCP following one- or two-level discectomy proved to be an effective treatment for cervical spondylotic radiculopathy and/or myelopathy. Supplemented anterior plate fixation can promote interbody fusion and prevent cage subsidence but do not improve the 2-year outcome when compared with those treated without anterior plate fixation. The need for interbody fusion or stabilization after anterior cervical microdiscectomy is still debated. The objectives of this prospective randomized study were 1) to examine whether combined interbody fusion and stabilization is more beneficial than microdiscectomy only (MDO) and 2) if fusion is found to be more beneficial than MDO, to determine which is the best method of fusion by comparing the results achieved using autologous bone graft (ABG), polymethylmethacrylate (PMMA) interposition, and threaded titanium cage (TTC).
                A total of 125 patients with a single-level cervical disc disease were included in this prospective study. All patients were randomized and assigned to one of the four following groups: Group 1 (33 patients), MDO; Group 2 (30 patients), microdiscectomy followed by ABG; Group 3 (26 patients), microdiscectomy followed by injection of PMMA; and Group 4 (36 patients), microdiscectomy followed by placement of a TTC. Clinical outcome according to Odom criteria was summarized as 1) excellent and good or 2) satisfactory and poor. One-year follow-up examination was performed in 123 patients. Patients in the TTC group experienced a significantly better outcome 6 months after surgery (92% excellent and good results) compared with those in the MDO and ABG groups (72.7 and 66.6% excellent and good results, respectively). Twelve months after surgery there was still a significant difference in outcomes between the TTC group (94.4% excellent and good results) and the MDO group (75.5% excellent and good results). Outcome in patients treated with PMMA was comparable with that in those treated with TCC after 6 (91.6%) and 12 months (87.5%), but no segmental fusion was achieved. Differences compared with MDO and ABG were, however, not significant, which may be related to the smaller number of patients in the PMMA group.
                Interbody cage-assisted fusion yields a significantly better short- and intermediate-term outcome than MDO in terms of return to work, radicular pain, Odom criteria, and earlier fusion. In addition, the advantages of interbody cages over ABG fusion included better results in terms of return to work, Odom criteria, and earlier fusion after 6 months. These results suggest that interbody cage-assisted fusion is a promising therapeutic option in patients with single-level disc disease. Polymethylmethacrylate seems to be a good alternative to interbody cage fusion but is hindered by the absence of immediate fusion. A prospective, randomized, pilot clinical trial compared recombinant human bone morphogenetic protein-2 (rhBMP-2) with iliac crest autograft bone for the treatment of human cervical disc disease.
                To examine the safety and effectiveness of using INFUSE Bone Graft (rhBMP-2 applied to an absorbable collagen sponge), as compared with an autogenous iliac crest bone graft placed inside the CORNERSTONE-SR fibular allograft, in anterior cervical discectomy and interbody fusion.
                Recombinant human bone morphogenetic protein-2 is an osteoinductive protein that induces a reliable fusion in the lumbar spine, but it has not been studied in patients with degenerative cervical disc disease.
                For this study, 33 patients with degenerative cervical disc disease were randomly assigned to investigational or control groups. The investigational group received a fibular allograft (CORNERSTONE-SR Allograft Ring) with an rhBMP-2-laden collagen carrier inside the graft along with an ATLANTIS anterior cervical plate. The control group received a fibular allograft with cancellous iliac crest autograft placed inside it, along with an ATLANTIS anterior cervical plate. The patients underwent plain radiographs at 6 weeks, then at 3, 6, 12, and 24 months, and CT scans at 3 and 6 months after surgery. They also completed general health profiles and self-evaluation scales. Adverse events were evaluated for severity, duration, association with the implant, and the need for a second surgical procedure.
                All the patients evaluated had solid fusions 6, 12, and 24 months after surgery. There were no device-related adverse events. At 24 months, the investigational group had mean improvement superior to that of the control group in neck disability and arm pain scores (P < 0.03 each).
                This pilot study demonstrates the feasibility of using rhBMP-2 safely and effectively in the cervical spine. Intervertebral carbon fiber cages may reduce graft collapse and promote bony fusion. Their safety and efficacy in the cervical spine have been investigated; however, no study has compared the outcomes of anterior cervical decompression and placement of a carbon fiber cage with placement of allograft and plate.
                Forty consecutive patients who met inclusion criteria were enrolled and randomized to anterior cervical discectomy with carbon fiber cage alone (n=20) or with allograft with plating (n=20). Clinical and radiographic evaluations were performed at baseline and at 6 weeks, 3, 6, 12 and 24 months. Neck and arm pain as well as neck disability index (NDI) were assessed at every visit. The Short Form (SF)-36 was completed prior to operation and at 12-month intervals. Cervical radiographs were evaluated pre-op and at every follow-up for evidence of fusion and instability.
                No significant difference was found between the two randomized groups with respect to pre-operative age (mean 50 years), sex, employment status, duration of pain or cervical levels affected. The mean follow-up period was 14 months (range, 6-26 months). The clinical pain and disability improvements were similar for both treatments. Post-operative donor site pain was only present in the cage group, but not of significant long-term disability. At up to 24 months, NDI scores were significantly improved in both groups when compared with baseline. At 12 and 24 months, all SF-36 questionnaire responses were also improved in both the treatment groups. However, there was no statistically significant difference in outcomes between the two groups at any time. The fusion rate was 100% in both groups by 12 and 24 months, without evidence of instability. There were no differences in complications between both groups.
                The outcomes after cervical decompression and placement of a carbon fiber cage appear to be similar to cervical decompression with allograft and plating by the Smith-Robinson technique. The authors report the results of a prospective randomized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical degenerative disc disease (DDD).
                Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and randomly assigned to one of two treatment groups: 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System (Medtronic Sofamor Danek); 265 patients in the control group underwent decompressive ACDF. Eighty percent of the arthroplasty-treated patients (223 of 276) and 75% of the control patients (198 of 265) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery. Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group. The arthroplasty group also had a statistically significant higher rate of neurological success (p = 0.005) as well as a lower rate of secondary revision surgeries (p = 0.0277) and supplemental fixation (p = 0.0031). The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months, as was relief of neck pain. The patients in the investigational group returned to work 16 days sooner than those in the control group, and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well (p = 0.0492, log-rank test). The cervical disc implant maintained segmental sagittal angular motion averaging more than 7 degrees. In the investigational group, there were no cases of implant failure or migration.
                The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success, improved clinical outcomes, and a reduced rate of secondary surgeries compared with ACDF. Between February 1985 and March 1990 44 patients with degenerative spondylolisthesis underwent primary surgery for spinal stenosis (in all cases the decompression preserved the facets bilaterally without discectomy) and were studied prospectively. Forty-three patients have been followed for > or = 2 years and are the basis of this study. There were three treatment groups: group I, no fusion (nine patients); group II, transverse process fusion with autogenous iliac bone graft without instrumentation (11 initial patients, with one lost to follow-up for a total of 10); and group III, transverse process fusion with autogenous iliac crest bone graft and instrumentation (24 patients, 18 with one-level pedicle fixation and six with two-level fixation). A higher proportion of group III subjects had a successful fusion compared with group II (p = 0.002). There was significantly more spondylolisthesis progression in groups I and II than in group III (p = 0.001). A higher proportion of "spondylolisthesis unchanged subjects" reported they were helped by the surgery than those whose spondylolisthesis progressed postoperatively (p < 0.01). Nonautologous interbody fusion materials are utilised in increasing numbers after anterior cervical disc surgery to overcome the problem of donor site morbidity of autologous bone grafts. This study investigates the performance of two nonautologous materials, the bone cement Polymethylmethacrylate (PMMA) and titanium cages. This prospective randomised trial, with assessment of the results by an independent observer, evaluates whether a Polymethylmethacrylate (PMMA) spacer or a titanium cage provides a better fusion rate around the implant and a better clinical outcome.
                Between 2000 and 2002, 115 patients with monoradicular cervical nerve root compression syndrome caused by soft cervical disc herniation were eligible for this study. Myelopathy, excessive osteophyte formation, and adjacent level degeneration were exclusion criteria. A block-restricted randomisation was applied. The 2-year clinical outcome served as the primary endpoint of the study. Clinical outcome was assessed according to the Odom scale by an independent observer at the follow-up examination. Preoperative, postoperative, and follow-up radiographs were taken.
                The study was completed by 107 patients (53 with PMMA and 54 with titanium cage). No significant difference between the two groups could be established with respect to the clinical outcome. In each group, 26 patients scored excellent. Good results were found in 19 PMMA patients and 16 titanium cage patients; satisfactory results were found in 8 PMMA patients and 9 titanium cage patients; bad results were found in 3 titanium cage patients. In 47 titanium cage cases (87%), fusion occurred radiologically as bony bridging around the implant. The fusion rate was significantly lower (p=0.011) in the PMMA group, with 35 cases (66%) united at follow-up.
                The radiological result of the titanium cage is superior to that of PMMA with respect to the fusion rate. Although the titanium cage achieves a better fusion rate, there is no difference between titanium cages and PMMA with respect to the clinical outcome. The objective of our study was to assess the efficacy of Graf ligamentoplasty in comparison with rigid fixation and fusion with the Hartshill horseshoe cage for similar severity of disc degeneration. Although studies have been done on the Graf ligamentoplasty procedure and the Hartshill horseshoe cage, their efficacy has never been compared in any study. This study was done to decide whether retaining mobility and stabilizing the spine is best or stiffening the lumbar segment by fusion is preferable. Between 1995 and 1997, a prospective randomized study was performed comparing Graf ligament stabilization and anterior lumbar interbody fusion. Twenty-eight patients had single-level Graf ligaments inserted and 27 patients had single-level anterior lumbar interbody fusion (ALIF) with a Hartshill horseshoe cage and tricortical iliac crest autograft. The two groups were similar in age, sex, symptoms, severity of the disc degeneration, and duration of follow-up. The chi-square test and t-test were used to evaluate the outcome. At a minimum follow-up of 2.1 years, we found that 93% of patients who had undergone Graf ligamentoplasty had a satisfactory outcome (rated "excellent" or "better") compared to 77.8% of patients who had been treated with ALIF with Hartshill horseshoe cage stabilization and fusion, when measured on the Oswestry Disability Index ( P<0.05). Retaining mobility in the lumbar segments gives better results after stabilisation with Graf ligaments than rigid fixation and fusion with the Hartshill horseshoe cage in the short term. We will be watching this cohort of patients over the next few years. Cervical total disc replacement (CTDR) represents a relatively novel procedure intended to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. This prospective, randomized, multicenter study evaluates the safety and efficacy of a new metal-on-metal CTDR implant (Kineflex|C) by comparing it with ACDF in the treatment of single-level spondylosis with radiculopathy.
                The study was a prospective, randomized US FDA Investigational Device Exemption (IDE) pivotal trial conducted at 21 centers across the US. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) scores, and a composite measure of clinical success. Patients were randomized to CTDR using the Kineflex|C (SpinalMotion, Inc.) cervical artificial disc or ACDF using structural allograft and an anterior plate.
                A total of 269 patients were enrolled and randomly assigned to either CTDR (136 patients) or to ACDF (133 patients). There were no significant differences between the CTDR and ACDF groups when comparing operative time, blood loss, length of hospital stay, or the reoperation rate at the index level. The overall success rate was significantly greater in the CTDR group (85%) compared with the ACDF group (71%) (p = 0.05). In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 24-month follow-up (p < 0.0001). Similarly, the VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 24-month follow-up (p < 0.0001). The range of motion (ROM) in the CTDR group decreased at 3 months but was significantly greater than the preoperative mean at 12- and 24-month follow-up. The ROM in the ACDF group was significantly reduced by 3 months and remained so throughout the follow-up. Adjacent-level degeneration was also evaluated in both groups from preoperatively to 2-year follow-up and was classified as none, mild, moderate, or severe. Preoperatively, there were no significant differences between groups when evaluating the different levels of adjacent-level degeneration. At the 2-year follow-up, there were significantly more patients in the ACDF group with severe adjacent-level radiographic changes (p < 0.0001). However, there were no significant differences between groups in adjacent-level reoperation rate (7.6% for the Kineflex|C group and 6.1% for the ACDF group).
                Cervical total disc replacement allows for neural decompression and clinical results comparable to ACDF. Kineflex|C was associated with a significantly greater overall success rate than fusion while maintaining motion at the index level. Furthermore, there were significantly fewer Kineflex|C patients showing severe adjacent-level radiographic changes at the 2-year follow-up. These results from a prospective, randomized study support that Kineflex|C CTDR is a viable alternative to ACDF in select patients with cervical radiculopathy. Parallel design, prospective, double-blinded, randomized, controlled trial composed of 2 independent groups treated with a continuous infusion catheter (saline vs. Marcain) placed into the iliac crest bone graft site (ICBG).
                To determine the long-term effects of postoperative continuous local anesthetic agent infusion at the ICBG harvest site in reducing chronic pain, narcotic usage and improving long-term, postoperative function and satisfaction with the surgical procedure.
                Harvesting iliac crest bone has been shown to be a source of pain and morbidity. In our initial study, we reported that patients who received local anesthetic at the graft site noted a reduction in acute postoperative pain (VAS) and narcotic usage. METHODS.: Twenty-six patients underwent posterior iliac crest bone graft harvesting. Patients were randomly assigned to receive 96 mL (2 mL/h x 48 hours) of either 0.5% Marcain or normal saline delivered via a continuous infusion catheter placed at the ICBG harvest site. Postoperative pain scores, narcotic use/frequency, activity level, and length of stay (LOS) were recorded and reported previously. At a minimum of 4 years after surgery (mean, 4.7 years; range, 4.5-5.4 years), all patients completed a questionnaire documenting their current VAS pain score (iliac crest), frequency of pain (days per month), level of activity, chronic pain at the ICBG site, and overall satisfaction with the procedure.
                Nine of 11 patients (82%) in the treatment group and 10 of 14 patients (71%) in the control group were available at final follow-up (1 death occurred in the control group unrelated to the study). The treatment group had a statistically significant decrease in the graft site pain VAS score (1.4 vs. 4.8) and increased satisfaction with the procedure at a minimum of 4 years postprocedure (P < 0.05). Additionally, no patient in the treatment group developed chronic iliac crest dysesthesias (0 of 9) versus 7 of 10 patients (70%) in the control group (P < 0.05).
                Continuous infusion of 0.5% Marcain at the ICBG harvest site significantly reduced chronic dysesthesias. Overall satisfaction with the procedure, number of painful days per month, and VAS scores were significantly better in the treatment group at 4 years. No long-term complications were attributed to either the ICBG site or the catheter-infusion system. The use of continuous local anesthetic infusion at the iliac crest may help in alleviating graft-related pain beyond the perioperative phase. Conflicting views exist according to the individual philosophy about various plate designs that can be used in anterior cervical discectomy and fusion (ACDF) to achieve clinical and radiological improvement within shortest time period. No prospective randomized study has ever been conducted to clarify the relationship between clinical outcomes, fusion rates, and the choice of plate (static vs. dynamic design).
                To compare the clinical and radiological outcomes of patients treated with one-level or multiple levels ACDF using cervical plates of dynamic (slotted-holes) versus static (fixed-holes) design.
                Single masked, prospective, randomized study.
                Over a 4-year period, 66 patients (M:F=37:29) had ACDF using either dynamic (n=33) or static (n=33) plates for intractable radiculopathy as the result of degenerative cervical spine disease. Overall, 28 patients had single-level fusion and 38 had two or three levels fused.
                Visual Analogue Pain scores (VASs), Neck Disability Index (NDI), and radiological criteria of established fusion.
                The qualifying subjects were randomized to receive ACDF using either fixed-holes (static) or the slotted-holes (dynamic) anterior cervical plates. Clinical and radiographic data were collected and analyzed. Paired-sample t test was used to correlate clinical and radiological outcomes and General Linear Model Analysis of Variance (GLM ANOVA) with repeated measures was used to detect outcome differences between the two groups for single and multiple fusions.
                At a mean follow-up of 16 months (range, 12-24), 49 patients (73.7%) had clinical success and 56 (85%) showed radiological fusion. Although clinical success was a predictor of fusion (p=.043), the reverse was not true (p=.61). In single-level fusion, no statistical difference of outcome was observed between the two groups but multilevel fusions with dynamic plate showed significantly lower VAS and NDI than those with static plates (p=.050).
                Although clinical improvement is a good predictor of successful ACDF, radiological evidence of fusion alone is not reliable as a parameter of success. The design of plate does not affect the outcomes in single-level fusions but statistics indicate that multiple-level fusions may have better clinical outcome when a dynamic plate design is used. One hundred fifteen patients having symptomatic cervical disc disease were recruited prospectively for this study. They were allocated randomly for either autologous iliac bone graft or biocompatible osteoconductive polymer implants. Both groups were compared clinically and radiologically.
                Complications, long-term clinical and radiologic outcome, and hospital stay were compared to determine if biocompatible osteoconductive polymer was an improvement on iliac bone graft in terms of reduced donor site pain and shortened hospital stay.
                Donor site morbidity is a significant problem in anterior cervical fusion. Hospital stay is another factor in the recent era of cost consciousness. Biocompatible osteoconductive polymer has been used in many centers as a biodegradable implant to circumvent these problems.
                Smith-Robinson technique was used in 74 patients, and Cloward technique was used in 41 patients. Sixty-five patients had biocompatible osteoconductive polymer implants, and 50 patients had iliac bone graft. Patients were followed-up routinely in the outpatient clinic where pain visual analogue scale and Odom's criteria were used for outcome evaluation. Plain radiography, computed tomography scan, and magnetic resonance imaging were used for radiologic evaluation.
                The mean hospital stay was 4.8 days for those with iliac bone graft and 4.7 days for those with biocompatible osteoconductive polymer. Clinical outcome was identical in both groups. The incidence of partial graft protrusion and postoperative intersegmental kyphosis was statistically higher with iliac bone graft (P = 0.018 and P = 0.02, respectively). "Sclerosis" started to form around biocompatible osteoconductive polymer like a "halo" at 2 months. It increased with time, and sometimes was associated with new osteophyte formation; however, there was no biocompatible osteoconductive polymer incorporation or biodegradation
                Biocompatible osteoconductive polymer acts as a good "spacer" that reduces graft collapse and intersegmental kyphosis. However, it did not show any radiologic evidence of biodegradation or incorporation during the follow-up period of 24 months. Anterior cervical plate fixation is an approved surgical technique for cervical spine stabilization in the presence of anterior cervical instability. Rigid plate design with screws rigidly locked to the plate is widely used and is thought to provide a better fixation for the treated spinal segment than a dynamic design in which the screws may slide when the graft is settling. Recent biomechanical studies showed that dynamic anterior plates provide a better graft loading possibly leading to accelerated spinal fusion with a lower incidence of implant complications. This, however, was investigated in vitro and does not necessarily mean to be the case in vivo, as well. Thus, the two major aspects of this study were to compare the speed of bone fusion and the rate of implant complications using either rigid- or dynamic plates. The study design is prospective, randomized, controlled, and multi-centric, having been approved by respective ethic committees of all participating sites. One hundred and thirty-two patients were included in this study and randomly assigned to one of the two groups, both undergoing routine level-1- or level-2 anterior cervical discectomy with autograft fusion receiving either a dynamic plate with screws being locked in ap - position (ABC, Aesculap, Germany), or a rigid plate (CSLP, Synthes, Switzerland). Segmental mobility and implant complications were compared after 3- and 6 months, respectively. All measurements were performed by an independent radiologist. Mobility results after 6 months were available for 77 patients (43 ABC/34 CSLP). Mean segmental mobility for the ABC group was 1.7 mm at the time of discharge, 1.4 mm after 3 months, and 0.8 mm after 6 months. For the CSLP- group the measurements were 1.0, 1.8, and 1.7 mm, respectively. The differences of mean segmental mobility were statistically significant between both groups after 6 months (P = 0.02). Four patients of the CSLP-group demonstrated surgical hardware complications, whereas no implant complications were observed within the ABC-group (P = 0.0375). Dynamic plate designs provided a faster fusion of the cervical spine compared with rigid plate designs after prior spinal surgery. Moreover, the rate of implant complications was lower within the group of patients receiving a dynamic plate. These interim results refer to a follow-up period of 6 months after prior spinal surgery. Further investigations will be performed 2 years postoperatively. Randomized, controlled, multicenter, investigational device exemption trial.
                To investigate the safety and effectiveness of the first two-piece, metal-on-metal lumbar disc prosthesis for treating patients with single-level degenerative disc disease.
                For patients with degenerative disc disease unresponsive to conservative measures, lumbar disc arthroplasty provides an alternative to fusion designed to relieve persistent discogenic pain and maintain motion.
                After 2:1 randomization, 577 patients were treated in either the investigational group (405), receiving lumbar disc arthroplasty, or the control group (172), receiving anterior lumbar interbody fusion. Patients were evaluated preoperatively, at surgery/discharge, and at 1.5, 3, 6, 12, and 24 months after surgery. The primary study endpoint was overall success, a composite measure of safety and effectiveness as recommended by the Food and Drug Administration and defined in the protocol.
                Both treatment groups demonstrated significant improvements compared with preoperative status. The investigational group had statistically superior outcomes (P < 0.05) at all postoperative evaluations in Oswestry Disability Index, back pain, and Short Form-36 Physical Component Summary scores as well as patient satisfaction. Investigational patients had longer surgical times (P < 0.001) and greater blood loss (P < 0.001) than did control patients; however, hospitalization stays were similar for both groups. Investigational patients had fewer implant or implant/surgical procedure-related adverse events (P < 0.001). Return-to-work intervals were reduced for investigational patients. Disc height and segmental angular motion were maintained throughout the study in the investigational group. In the investigational group, overall success superiority was found when compared to the control group as defined by the Food and Drug Administration Investigational Device Exemption protocol.
                The investigational group consistently demonstrated statistical superiority versus fusion on key clinical outcomes including improved physical function, reduced pain, and earlier return to work. One hundred, twenty-four patients undergoing lumbar or lumbosacral fusion for degenerative conditions were entered into a prospective study. The patients were randomly assigned to one of three treatment groups. Group I underwent posterolateral fusion using autogenous bone graft. Group II had autogenous posterolateral fusions supplemented by a semi-rigid pedicle screw/plate fixation system (Luque II; Danek Medical, Memphis, Tennessee). Group III patients underwent posterolateral autogenous fusion with a rigid pedicle screw/rod fixation system (Texas Scottish Rite Hospital [TSRH]-Danek Medical, Memphis, Tennessee). All the patients were operated on by the same surgeon, identical bone grafting technique was used in all, and all were treated in an identical fashion postoperatively. Fusion status was determined from the anteroposterior, oblique, and flexion-extension radiographs obtained at 1 year. Clinical results were rated as excellent if the patients were pain-free and had returned to work; good if the patients had mild backache requiring non-narcotic analgesics and had returned to work; fair if continuing back pain prevented a return to work; or poor if the pain was worse than that which the patient experienced preoperatively or the patient required revision surgery. Nine patients who were originally assigned to Group II or Group III were placed in Group I intraoperatively. This change was due to the identification of severe osteopenia and the determination that pedicle screw purchase was poor. One patient was lost to follow-up. Thus, 51 patients were in Group I, 35 in Group II, and 37 in Group III. Follow-up ranged from 9 to 28 months, averaging 16 months.(ABSTRACT TRUNCATED AT 250 WORDS) A prospective, randomized, multicenter study of surgical treatment of cervical disc disease.
                To assess the safety and efficacy of cervical disc arthroplasty using a new arthroplasty device at 24-months follow-up.
                Cervical disc arthroplasty preserves motion in the cervical spine. It is an alternative to fusion after neurologic decompression, whereas anterior decompression and fusion provides a rigorous comparative benchmark of success.
                We conducted a randomized controlled multicenter clinical trial enrolling patients with cervical disc disease. Ultimately 242 received the investigational device (Bryan Cervical Disc), and 221 patients underwent a single-level anterior cervical discectomy and decompression and fusion as a control group. Patients completed clinical and radiographic follow-up examinations at regular intervals for 2 years after surgery.
                Analysis of 12- and 24-month postoperative data showed improvement in all clinical outcome measures for both groups; however, 24 months after surgery, the investigational group patients treated with the artificial disc had a statistically greater improvement in the primary outcome variables: Neck disability index score (P = 0.025) and overall success (P = 0.010). With regard to implant- or implant/surgical-procedure-associated serious adverse events, the investigational group had a rate of 1.7% and the control group, 3.2%. There was no statistical difference between the 2 groups with regard to the rate of secondary surgical procedures performed subsequent to the index procedure. Patients who received the artificial cervical disc returned to work nearly 2 weeks earlier than the fusion patients (P = 0.015).
                Two-year follow-up results indicate that cervical disc arthroplasty is a viable alternative to anterior cervical discectomy and fusion in patients with persistently symptomatic, single-level cervical disc disease.
When the working mechanism for pain relief and functional improvement is fusion of the motion segment, there is low quality evidence that iliac crest autograft appears to be the better technique. When ignoring fusion rates and looking at complication rates, a cage has a weak evidence base over iliac crest autograft, but not over discectomy alone. Future research should compare additional instrumentation such as screws, plates, and cages against discectomy with or without autograft.