A prospective, randomized study comparing the results of open discectomy with those of video-assisted arthroscopic microdiscectomy. Outcome after lumbar sequestrectomy compared with microdiscectomy: a prospective randomized study. Report of a controlled clinical trial comparing automated percutaneous lumbar discectomy and microdiscectomy in the treatment of contained lumbar disc herniation. Anterior cervical microdiscectomy with or without fusion. A prospective randomized trial of chemonucleolysis and conventional disc surgery in single level lumbar disc herniation. Safety and efficacy of chymopapain (Discase) in the treatment of sciatica due to a herniated nucleus pulposus. Results of a randomized, double-blind study. Percutaneous endoscopic discectomy: surgical technique and preliminary results compared to microsurgical discectomy. Discectomy versus discectomy with fusion versus discectomy with fusion and instrumentation: a prospective randomized study. Surgery versus chemonucleolysis for herniated lumbar discs. A prospective study with random assignment. Can exercise therapy improve the outcome of microdiscectomy? A controlled study of microsurgical versus standard lumbar discectomy. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. A comparison of surgery and chemonucleolysis in the treatment of sciatica. A prospective randomized trial. Discectomy strategies for lumbar disc herniation: results of the LAPDOG trial. The perioperative use of corticosteroids and bupivacaine in the management of lumbar disc disease. Chemonucleolysis and automated percutaneous discectomy--a prospective randomized comparison. Clinical trial of postoperative dynamic back exercises after first lumbar discectomy. Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. The value of accurate clinical assessment in the surgical management of the lumbar disc protrusion. Prevention of peridural fibrosis: current methodologies. ProDisc artificial total lumbar disc replacement: introduction and early results from the United States clinical trial. Full-endoscopic anterior decompression versus conventional anterior decompression and fusion in cervical disc herniations. [Comparative study of short-term results between total artificial disc prosthesis and anterior lumbar interbody fusion]. Efficacy of dynamic lumbar stabilization exercise in lumbar microdiscectomy. Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up. Anterior cervical discectomy (ACD) versus anterior cervical fusion (ACF), clinical and radiological outcome study. Chemonucleolysis versus discectomy: a randomized multicenter trial. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Lumbar micro disc surgery with and without autologous fat graft. A prospective randomized trial evaluated with reference to clinical and social factors. Double-blind evaluation of intradiscal chymopapain for herniated lumbar discs. Early results. Less systemic cytokine response in patients following microendoscopic versus open lumbar discectomy. Anterior cervical discectomy with or without fusion with acrylate. A randomized trial. A prospective randomized study of anterior single-level cervical disc operations with long-term follow-up: surgical fusion is unnecessary. Lumbar spine arthroplasty: early results using the ProDisc II: a prospective randomized trial of arthroplasty versus fusion. Rehabilitation after surgery for lumbar disc herniation: results of a randomized clinical trial. Intensive dynamic back exercises with or without hyperextension in chronic back pain after surgery for lumbar disc protrusion. A clinical trial.
The usefulness of video-assisted arthroscopic microdiscectomy for the treatment of a herniated lumbar disc has been studied previously. In the current prospective, randomized study, the results of this procedure were compared with those of conventional open laminotomy and discectomy.
                Sixty patients who had objective evidence of a single intracanalicular herniation of a lumbar disc caudad to the first lumbar vertebra were randomized into two groups consisting of thirty patients each; Group 1 was managed with open laminotomy and discectomy, and Group 2 was managed with video-assisted arthroscopic microdiscectomy. None of the patients had had a previous operation on the low back, and all had failed to respond to nonoperative measures. Analysis of the outcomes of both procedures was based on the patient's self-evaluation before and after the operation, the preoperative and postoperative clinical findings, and the patient's ability to return to a functional status. The patients were followed for nineteen to forty-two months postoperatively.
                On the basis of the patient's preoperative and postoperative self-evaluation, the findings on physical examination, and the patient's ability to return to work or to normal activity, twenty-eight patients (93 percent) in Group 1 and twenty-nine patients (97 percent) in Group 2 were considered to have had a satisfactory outcome. The mean duration of postoperative disability before the patients were able to return to work was considerably longer in Group 1 than in Group 2 (forty-nine compared with twenty-seven days). The patients in Group 1 used narcotics for a longer duration postoperatively. No neurovascular complications or infections were encountered in either group.
                Although the rate of satisfactory outcomes was approximately the same in both groups, the patients who had had an arthroscopic microdiscectomy had a shorter duration of postoperative disability and used narcotics for a shorter period. These findings suggest that arthroscopic microdiscectomy may be useful for the operative treatment of specific symptoms, including radiculopathy, that are caused by lumbar disc herniation, provided that patients are properly selected--that is, they must have a herniated disc at a single level as confirmed on imaging studies, have failed to respond to nonoperative management, have no evidence of spinal stenosis, and have a herniation not exceeding one-half of the anteroposterior diameter of the spinal canal. Moreover, the surgeon must be familiar with this technique and must have received training in its use. Microdiscectomy currently constitutes the standard treatment for herniated lumbar discs. Although limiting surgery to excision of fragments has occasionally been suggested, prospective data are lacking. Therefore, the objective of this study was to compare early outcome and recurrence rates after sequestrectomy and microdiscectomy.
                Eighty-four consecutive patients 60 years of age or younger who harbored free, subligamentary, or transanular herniated lumbar discs refractory to conservative treatment were randomized to one of two treatment groups. Intraoperative parameters and findings were documented as well as pre- and postoperative symptoms such as pain, Patient Satisfaction Index (PSI), Prolo Scale score, and Short Form (SF)-36 subscale results. Follow up of at least 12 months was available in 73 patients (87%). Preoperative intergroup symptoms did not differ significantly. Surgery was significantly shorter in the sequestrectomy-treated group. Overall, low-back pain and sciatica were drastically reduced in both groups and most sensorimotor deficits improved. At 4 to 6 months, SF-36 subscales and PSI scores showed a trend in favor of sequestrectomy, leaving 3% of patients unsatisfied compared with 18% of those treated with discectomy. Outcome according to the Prolo Scale was good or excellent in 76% of discectomy-treated patients and 92% of sequestrectomy-treated patients. Reherniation occurred in four patients after discectomy (10%) and two patients after sequestrectomy (5%) within 18 months.
                Sequestrectomy does not seem to entail a higher rate of early recurrences compared with microdiscectomy. Analysis of early outcome demonstrated a trend toward superior results when sequestrectomy is performed. Although long-term follow-up data are mandatory, sequestrectomy may be an advantageous alternative to standard microdiscectomy. The results of a randomized controlled trial comparing automated percutaneous lumbar discectomy (APLD) with lumbar microdiscectomy for the treatment of small contained lumbar discal herniations are reported. All patients gave full informed consent and were assessed by an independent observer. Seventy-one patients with radiologically confirmed small contained lumbar disc herniations were randomly assigned to undergo either APLD or lumbar microdiscectomy. All patients were formally assessed by the independent assessor using the Macnab outcome classification at 3 weeks, 2 months, and 6 months after the procedure with follow-up being continued for the duration of the study.
                The objective was to complete the first randomized and blinded study with sufficient numbers to provide a valid statistical evaluation of these procedures.
                No previous randomized controlled study comparing these methods has been previously reported.
                Each procedure was performed by the same surgeon using standard techniques. Statistical analysis was by the chi-square method.
                In the APLD group only 9 of 31 (29%) had satisfactory outcomes as compared to 32 of 40 (80%) for the microdiscectomy group. Of those patients in the APLD group who had an unsatisfactory outcome and who then opted to undergo surgery (20 of 22 patients), the final success rate was only 65%. Thus, the cumulative success rate of the group initially randomized to APLD including those undergoing either APLD alone or APLD and microdiscectomy after unsuccessful APLD was 22 of 31 (71%).
                In this group of patients, APLD is seen to be ineffective in the treatment of contained lumbar disc herniation. 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. The role of chemonucleolysis as an alternative to disc surgery is still disputed. The authors conducted a prospective randomized controlled trial of chemonucleolysis and conventional disc surgery involving 92 patients with L4-5 or L5-S1 disc herniation who failed to respond to conservative treatment. There were 46 patients in each group, matched for demographic, clinical characteristics, and co-interventions. Independent examiners assessed patients before treatment, at 6 weeks after, 3 months after, and 1 year after treatment. A comprehensive method of outcome assessment involving physiological outcome, functional outcome, cost outcome, and psychological outcome was employed. Nine chemonucleolysis patients and one disc surgery patient required additional surgery for failure of initial treatment (P less than 0.02). The outcomes at 6 weeks and at 3 months were better in the surgical group, but at 1 year the differences were not significant. The authors conclude that chemonucleolysis as a minimally invasive technique produces inferior short-term results and offers no advantage over conventional discectomy. A prospective, multiinstitutional, double-blind trial comparing the effect of chymopapain (Discase) vs. placebo (cysteine-edetate-iothalamate: CEI) for lumbar intervertebral disc rupture with sciatica was carried out on 173 patients, the largest such study reported to date. Patients were matched with respect to age, sex, physical habitus, and level of injection. The procedure was carried out under local anaesthesia. The success rate was superior in the chymopapain group regardless of the method used to assess outcome or the time over the first 6 months at which the two groups were compared: 71% vs. 45% if code breaks were analyzed at 6 months, and 67% vs. 44% if code breaks were defined as lost to follow-up. A single case of anaphylaxis and one case of septic discitis were the only serious complications noted. This study supports the role of chymopapain in the treatment of lumbar disc rupture with sciatica. Percutaneous endoscopic discectomy is a new technique for removing "contained" lumbar disc herniations (those in which the outer border of the anulus fibrosus is intact) and small "noncontained" lumbar disc herniations (those at the level of the disc space and occupying less than one-third of the sagittal diameter of the spinal canal) through a posterolateral approach with the aid of specially developed instruments. The technique combines rigid straight, angled, and flexible forceps with automated high-power suction shaver and cutter systems. Access can thus be gained to the dorsal parts of the intervertebral space where the disc herniation is located. Percutaneous endoscopic discectomy is monitored using an endoscope angled to 70 degrees coupled with a television and video unit and is performed with the patient under local anesthesia and an anesthesiologist available if needed. Its indication is restricted to discogenic root compression with a minor neurological deficit. Two groups of patients with contained or small noncontained disc herniations were treated by either percutaneous endoscopic discectomy (20 cases) or microdiscectomy (20 cases). Both groups were investigated in a prospective randomized study in order to compare the efficacy of the two methods. The disc herniations were located at L2-3 (one patient), L3-4 (two patients), or L4-5 (37 patients). There were no significant differences between the two groups concerning age and sex distribution, preoperative evolution of complaints, prior conservative therapy, patient's occupation, preoperative disability, and clinical symptomatology. Two years after percutaneous endoscopic discectomy, sciatica had disappeared in 80% (16 of 20 patients), low-back pain in 47% (nine of 19 patients), sensory deficits in 92.3% (12 of 13 patients), and motor deficits in the one patient affected. Two years after microdiscectomy, sciatica had disappeared in 65% (13 of 20 patients), low-back pain in 25% (five of 20 patients), sensory deficits in 68.8% (11 of 16 patients), and motor deficits in all patients so affected. Only 72.2% of the patients in the microdiscectomy group had returned to their previous occupation versus 95% in the percutaneous endoscopic discectomy group. Percutaneous endoscopic discectomy appears to offer an alternative to microdiscectomy for patients with "contained" and small subligamentous lumbar disc herniations. 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. The results of removal of a disc hernia at the L4/L5 level were compared with those obtained by the injection of 4000 IU (2 ml) of chymopapain (Discase) in 29 consecutive patients randomly selected for either treatment. All exhibited severe incapacitating sciatica, and all had a myelogram demonstrating a definite disc hernia. The two groups of patients did not differ significantly with regard to age, sex, or length of history. The total time of general anesthesia was significantly shorter for the injected patients by 20 minutes (p less than 0.01), as was the length of hospitalization, by three days (p less than 0.05). Within five months, eight of the patients receiving chymopapain injections had to be operated on because of unrelieved symptoms. All had definite disc herniae, and in four, a free fragment was found. All patients were seen at the time of dismissal from the hospital and at six and 12 months after operation by an independent observer. Comparisons made at these intervals, following either surgery or chymopapain injection with or without subsequent surgery, did not reveal any significant differences, but the short-term results following either treatment alone significantly (p less than 0.01) favored the surgical approach. A prospective randomized controlled trial of exercise therapy in patients who underwent microdiscectomy for prolapsed lumbar intervertebral disc. Results of a pilot study are presented.
                To determine the effects of a postoperative exercise program on pain, disability, psychological status, and spinal function.
                Microdiscectomy is often used successfully to treat prolapsed lumbar intervertebral disc. However, some patients do not have a good outcome and many continue to have low back pain. The reasons for this are unclear but impairment of back muscle function due to months of inactivity before surgery may be a contributing factor. A postoperative exercise program may improve outcome in such patients.
                Twenty patients who underwent lumbar microdiscectomy were randomized into EXERCISE and CONTROL groups. After surgery, all patients received normal postoperative care that included advice from a physiotherapist about exercise and a return to normal activities. Six weeks after surgery, patients in the EXERCISE group undertook a 4-week exercise program that concentrated on improving strength and endurance of the back and abdominal muscles and mobility of the spine and hips. Assessments of spinal function were performed in all patients during the week before surgery and at 6, 10, 26, and 52 weeks after. The assessment included measures of posture, hip and lumbar mobility, back muscle endurance capacity and electromyographic measures of back muscle fatigue. On each occasion, patients completed questionnaires inquiring about pain, disability and psychological status.
                Surgery improved pain, disability, back muscle endurance capacity and hip and lumbar mobility in both groups of patients. After the exercise program, the EXERCISE group showed further improvements in these measures and also in electromyographic measures of back muscle fatigability. All these improvements were maintained 12 months after surgery. The only further improvement showed by the CONTROL group between 6 and 52 weeks was an increase in back muscle endurance capacity.
                A 4-week postoperative exercise program can improve pain, disability, and spinal function inpatients who undergo microdiscectomy. [Key words: electromyogram median frequency, exercise therapy, intervertebral disc prolapse, microdiscectomy, randomized controlled trial, spinal function. The purpose of the study was to evaluate whether a microsurgical discectomy (MS), compared with a standard lumbar discectomy (SD), could reduce the stay at the hospital or the postoperative morbidity. The study was prospective and of 79 patients with "virgin' lumbar radiculopathy from only one nerve root, 39 were randomized to MS and 40 to SD. All patients had positive myelography or CT findings. The fascia incision was 31 and 70 mm (p < 0.0001), respectively, but the skin incision was of the same length in both groups to blind the study. For the MS and SD group of patients, the median operation time was 48 and 35 min (p < 0.0001), and the stay at the hospital was 5.2 and 4.6 days, respectively. The two groups were not different in sex, age, localization or type of herniated discs. Use of analgesic medicine and the presence of pain in the back or legs pre- and postoperative was the same. We conclude that in a controlled and prospective study, reducing the fascia incision and the muscular dissection from a median of 70-31 mm, does not shorten the length of a stay at a hospital and it has no influence on postoperative morbidity. Single blind randomized study.
                To compare the effectiveness of lumbar instrumented fusion with cognitive intervention and exercises in patients with chronic low back pain and disc degeneration.
                To the authors' best knowledge, only one randomized study has evaluated the effectiveness of lumbar fusion. The Swedish Lumbar Spine Study reported that lumbar fusion was better than continuing physiotherapy and care by the family physician.
                Sixty-four patients aged 25-60 years with low back pain lasting longer than 1 year and evidence of disc degeneration at L4-L5 and/or L5-S1 at radiographic examination were randomized to either lumbar fusion with posterior transpedicular screws and postoperative physiotherapy, or cognitive intervention and exercises. The cognitive intervention consisted of a lecture to give the patient an understanding that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it. This was reinforced by three daily physical exercise sessions for 3 weeks. The main outcome measure was the Oswestry Disability Index.
                At the 1-year follow-up visit, 97% of the patients, including 6 patients who had either not attended treatment or changed groups, were examined. The Oswestry Disability Index was significantly reduced from 41 to 26 after surgery, compared with 42 to 30 after cognitive intervention and exercises. The mean difference between groups was 2.3 (-6.7 to 11.4) (P = 0.33). Improvements inback pain, use of analgesics, emotional distress, life satisfaction, and return to work were not different. Fear-avoidance beliefs and fingertip-floor distance were reduced more after nonoperative treatment, and lower limb pain was reduced more after surgery. The success rate according to an independent observer was 70% after surgery and 76% after cognitive intervention and exercises. The early complication rate in the surgical group was 18%.
                The main outcome measure showed equal improvement in patients with chronic low back pain and disc degeneration randomized to cognitive intervention and exercises, or lumbar fusion. Fifty-two patients with unilateral sciatica caused by intervertebral disc herniation were selected on strict clinical and radiological criteria. All patients had failed to respond to conservative measures. Patients in this trial group randomly were allocated surgery or Chymopapain. During the same period, a further 71 patients, who were put forward for the trial, and did not fulfill the trial criteria, were offered Chymopapain as an alternative to surgery. Both groups were assessed at one month, three months, and one year--progress being recorded by clinical examination and visual analogs. The failure rate in the two Chymopapain groups were comparable, with 52% and 47%, but were significantly higher than the surgical group (11%). Surgery in the failed Chymopapain group frequently was delayed and unrewarding. Failures can be predicted at one month posttreatment, and early surgery may be indicated to prevent chronic scarring. Since its introduction in the 1970s percutaneous treatment of lumbar disc herniation has been an attractive concept that has been the object of technical development and clinical application throughout the world. Little scientific evaluation of the efficacy and effectiveness of the procedure has been done. To estimate the success rates of automated percutaneous and conventional discectomy in comparable patients and to document the resource consumption of patients treated in these ways, a multicenter randomized clinical trial designed to compare both treatment efficacy and cost-effectiveness of automated percutaneous discectomy and conventional discectomy in adult patients with no prior lumbar spinal surgery, no coexistent lumbar spinal disease, unilateral single level lumbar radiculopathy with images confirming disc herniation at the appropriate level. In the course of the trial important technical advances allowing epidural extraction of free-fragment disc herniation was incorporated into the trial. It was not possible to enroll the required number of patients to complete the trial. Of 5735 screened patients, 95 were eligible and 36 were enrolled. Two elected watchful waiting and did not have any surgical procedure. Eight patients were lost to follow-up. Among the 27 evaluable patients, 41% of the percutaneous discectomy patients and 40% of the conventional discectomy patients were assessed as achieving "success" on the primary outcome measure. No clinical trial of any percutaneous discectomy technique provides definitive evidence supporting the efficacy or effectiveness of the procedure. Such evidence should be required by patients to whom such procedures are proposed and those who are asked to pay for them.
                Copyright 2002 Elsevier Science Ltd. The introduction of microdiscectomy to lumbar spine surgery has resulted in a significant decrease in postoperative pain and length of hospital stay. Intraoperative application of long-acting local anesthetic agents has been used for many general and neurosurgical procedures for the management of postoperative pain. In addition, many surgeons routinely use intraoperative corticosteroids during lumbar discectomy to reduce traumatic nerve root inflammation. However, the efficacy of intraoperative long-acting local anesthetic agents and corticosteroids for reduction of postoperative discomfort has not been reported for lumbar discectomy. This study evaluated 32 patients at a university-based Veterans Administration hospital undergoing lumbar microdiscectomy. All 32 patients presented with radicular symptoms and had radiographic confirmation of a herniated nucleus pulposus. These patients were divided into three groups. Group 1 (12 patients) received 160 mg intramuscular Depo-Medrol (methylprednisolone acetate) and 250 mg intravenous Solu-Medrol (methyl-prednisolone sodium succinate) at the start of the operation. A macerated fat graft soaked in 80 mg Depo-Medrol was placed over the affected nerve root following discectomy. In addition, 30 ml of 0.25% bupivacaine was infiltrated into the paraspinal musculature at skin incision and during closure. Group 2 (10 patients) received 30 ml of 0.25% bupivacaine infiltrated into the paraspinal musculature at skin incision and at closure. In this group of patients, a saline-soaked fat graft was placed over the affected nerve root. Group 3 (10 patients) acted as a control group, undergoing lumbar microdiscectomy without corticosteroids or bupivacaine. Patients receiving bupivacaine and corticosteroids (Group 1) had a statistically significantly shorter hospital stay (1.4 days) compared to the control group (4.0 days) (p = 0.0004, Mann-Whitney U-test). Patients in Group 1 required less postoperative narcotic analgesia than the other groups. Finally, a larger percentage of patients in Group 1 reported complete relief of back and radicular pain on postoperative Day 1 compared to other groups. Postoperative complications and functional outcome were not different between the groups. These results indicate that the combination of long-acting anesthetic agents and corticosteroids can reduce postoperative discomfort and subsequently the length of postoperative hospital stay. In this prospective study 22 patients with painful disc herniations were randomized either to chemonucleolysis (CN) or automated percutaneous discectomy (APD) Preoperatively the Oswestry score was 44 points in the CN group and 41 points in the APD group. Except for a longer duration of preoperative leg pain in the APD group, clinical data were approximately the similar same in the two groups. In the APD group there was one intra-operative complication. Open revision surgery in the same segment was performed once in the CN group and twice in the APD group. Improvement of neurologic deficits and of Owestry score was significant in both groups. At 2 years after surgery the CN treated patients were significantly better with respect to Oswestry score, back pain and leg pain recurrence. Ninety-six patients who had undergone first-time discectomy for herniated lumbar intervertebral discs were consecutively randomized to two physical rehabilitation programs: a program of high-intensity, dynamic back extension and abdominal exercises with occurrence of low back pain being the limiting factor or a traditional program of mild, generally mobility-improving exercises within pain limits. Both groups underwent 14 hours of treatment during a 6-week period 5 weeks after surgery. At 26 weeks' follow-up, results indicated that patients who did the high-intensity exercises experienced greater success with regard to the patient disability-index and work capabilities. After 1 year, a trend that favored the use of intensive exercises could be observed. No differences were found in pain or objective measurements. A rehabilitation program of intensive exercises with occurrence of back pain being the limiting factor appears to increase patient behavioral support, resulting in work capacity improvements and patient self-rated disability levels. The results indicate that a 6-wk, 14-hr postoperative rehabilitation program is inadequate if objective postoperative deficit improvements are the desired goal. A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial.
                To evaluate the safety and effectiveness of the ProDisc-L (Synthes Spine, West Chester, PA) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1.
                As part of the Investigational Device Exemption clinical trial, favorable single center results of lumbar total disc replacement with the ProDisc-L have been reported previously.
                Two hundred eighty-six (286) patients were treated on protocol. Patients were evaluated before and after surgery, at 6 weeks, 3, 6, 12, 18, and 24 months. Evaluation at each visit included patient self-assessments, physical and neurologic examinations, and radiographic evaluation.
                Safety of ProDisc-L implantation was demonstrated with 0% major complications. At 24 months, 91.8% of investigational and 84.5% of control patients reported improvement in the Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index [ODI]) from preoperative levels, and 77.2% of investigational and 64.8% of control patients met the > or =15% Oswestry Disability Index improvement criteria. Overall neurologic success in the investigational group was superior to the control group (91.2% investigational and 81.4% control; P = 0.0341). At 6 weeks and 3 months follow-up time points, the ProDisc-L patients recorded SF-36 Health Survey scores significantly higher than the control group (P = 0.018, P = 0.0036, respectively). The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment (P < 0.0001). Visual analog scale patient satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group (P = 0.015). Radiographic range of motion was maintained within a normal functional range in 93.7% of investigational patients and averaged 7.7 degrees.
                ProDisc-L has been found to be safe and efficacious. In properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion by multiple clinical criteria. One hundred patients with lumbar disc protrusions were studied. Thirty six "control" patients were admitted in the same time period with low back pain and sciatica but with subsequently "normal" myelograms and no surgery. The aim of this paper was to relate history and clinical signs to the myelograms and surgical findings. Ninety nine per cent of our patients presented with sciatica (controls 94%). The most frequently found sign in patients with a disc protrusion was reduction of ipsilateral straight leg raising (98%). However, 55% of controls also showed this sign. There were three signs that, when present, particularly indicated a disc protrusion; "crossed straight leg raising" (pain on contralateral straight leg raising), measured calf wasting and impaired ankle reflex: the latter being especially indicative of an L5-S1 disc protrusion. There were two further important signs, weakness of dorsiflexion of the foot and scoliosis of the lumbar spine. However, such signs occurred in about half the patients and so clinical diagnosis in the remaining half depended on obtaining a good history of sciatica, and paying due regard to severity of the pain, the mobility of the patient, the ability and desire to work and the overall personality. Satisfactory results of surgery simply depend on finding and removing a definite disc protrusion. Using these methods of selection, 98% have returned to their original employment, 86% within 3 months of the operation. For a patient with no abnormal signs and a normal myelogram, surgical treatment should not be advised. Lumbar discectomy is a common surgical procedure with a physician-reported 'good' outcome of 85%-95% for successfully relieving pre-operative sciatic pain. Up to 40% of patients post-operatively, however, have persistent limitations in activity. Peridural fibrosis is a natural consequence of the normal post-operative healing that can cause symptoms by tethering the nerve roots. ADCON-L was developed to decrease the peridural fibrosis reaction. Cell culture analysis demonstrated that ADCON-L blocked the ingrowth of fibroblasts, and animal laminectomy models demonstrated a major decrease in the amount of peridural fibrosis. ADCON-L has been studied in two prospective randomized multicenter trials, one in Europe with 298 patients and the other in the United States with 223 patients at the interim analysis. Noting the differences in the quantity of peridural scar on post-operative MRI and in clinical outcome between the two groups assessed the effect of the addition of ADCON-L to the surgical procedure. Both studies had statistically significant positive beneficial effects in both the radiologic index and the clinical outcome scores. These two studies provide the evidence for the clinical use of ADCON-L to improve outcomes after lumbar discectomy. Multicenter prospective randomized study of artificial disc replacement (ProDisc) versus circumferential fusion (standard of care) for one- and two-level degenerative disc disease. This is an interim analysis on patients seen at the Spine Institute Saint John's Health Center, Santa Monica, California.
                To evaluate early pain and functional outcomes of patients treated with disc replacement or fusion and to assess the capacity of this intervertebral disc replacement for preserving motion in the lumbar spine.
                Disc replacement is intended to reduce pain via removal of the diseased disc while restoring physiologic motion and height at the affected level. The long-term physiologic advantage of disc replacement to fusion is that preservation of motion may prevent additional degeneration at adjacent levels.
                Patients meeting inclusion criteria were consented for study. Randomization was performed using a 2 to 1 ratio of disc replacement procedure to a fusion procedure. Patients rated their pain on the Visual Analogue Scale and completed the Oswestry Disability Index questionnaire. Radiographs were taken. Assessments were made before surgery and after surgery at 6 weeks, 3 months, 6 months, and 1 year (ongoing). Changes from preoperative pain, disability, or motion were separately evaluated as a function of treatment using repeated measures mixed design analysis of variance.
                This analysis includes data up to 6 months from the first 53 randomized patients. There were 35 patients who underwent disc replacements, and 18 patients had fusion procedures. Disc replacement patients had a significant reduction in pain and disability at earlier evaluations. By 6 months, the relative improvement on both the Visual Analogue Scale and Oswestry (both, P < 0.05) were similar for disc replacement and fusion patients. Greater motion was found at L4-L5 for disc replacement patients (P < 0.05) than fusion patients. A similar trend was noted at L5-S1 (P was not significant).
                Disc replacement patients reported significantly less pain (Visual Analogue Scale) and disability (Oswestry) in the early period following surgery compared to fusion patients. This difference disappeared by 6 months. When compared to fusion, the disc replacement allowed preservation of motion at L4-L5 with a similar trend at L5-S1. Anterior cervical decompression and fusion (ACDF) is the standard for cervical discectomies. With the full-endoscopic anterior cervical discectomy (FACD) a minimally invasive procedure is available. The objective of this prospective, randomised, controlled study was to compare the results of FACD with those of ACDF in mediolateral soft disc herniations. A total of 103 patients with ACDF or FACD were followed up for two years. In addition to general parameters specific measuring instruments were used. Postoperatively 85.9% of the patients no longer had arm pain, and 10.1% had occasional pain. There were no significant clinical differences between the decompression with or without fusion. The full-endoscopic technique afforded advantages in operation technique, rehabilitation and soft tissue injury. The recorded results show that FACD is a sufficient and safe alternative to conventional procedures when the indication criteria are fulfilled. At the same time, it offers the advantages of a minimally invasive intervention. The purpose of this study was to examine short-term clinical results with a lumbar disc prosthesis in comparison with anterior interbody fusion for the treatment of chronic low-back pain resulting from disc degeneration.
                This was a consecutive series of 32 patients who underwent surgery between 2002 and 2005 performed by the same surgeon. Patients were randomly assigned to one of two treatment arms: a Charité (Depuy) disc prosthesis was implanted in group 1; an intersomatic KLA cage (Scient'x) was implanted in group 2. All patients presented primary or postdiscectomy discopathy: Modic 1 or 2 on MRI and one level (L4-L5 or L5-S1) positive on discography. A visual analog scale (VAS) and the Oswestry test were noted preoperatively, at six months and at last follow-up and compared with Student's t test. The quantitative analysis was based on the rate of excellent results (60% gain on the VAS and 50% gain on the Oswestry), rate of return to work at three months and level of patient satisfaction.
                Patient follow-up ranged from one to three years. Mean age was 39 years in group 1 and 44 in group 2. The quantitative analysis showed an improvement in the VAS in both groups: 75% in group 1 and 67% in group 2. The difference was not statistically significant. For the Oswestry score, the gain in function was improved 51% in group 1 and 37% in group 2, with a statistically significant difference in favor of the prosthesis group (p=0.125). The qualitative analysis demonstrated that patient satisfaction (87 and 88%) was similar in the two groups, but with a clear difference for return to work at three months, with a better rate in the prosthesis group (61.5%) than the fusion group (42.8%). The rate of excellent outcome was greater in group 1 (77%) than in group 2 (55%).
                There is only one study in the literature, which can be compared with ours. Using the same methodology, that study observed less favorable results for the disc prosthesis than with anterior lumbar fusion.
                The lumbar disc prosthesis offers a possible alternative to lumbar arthrodesis for the treatment of severe disc degeneration at one level in the young subject. It has been found to enable more rapid and superior functional results. The aim of this study was to determine the efficacy of dynamic lumbar stabilization exercises in patients with lumbar microdiscectomy.
                A prospective, randomized, controlled study.
                Forty-two patients who were diagnosed as having lumbar disc herniation and had been operated on using the microdiscectomy method were divided randomly into 3 groups.
                Dynamic lumbar stabilization exercises were set for the first group and a home exercise programme for the second. The third group given no exercises was considered as a control group. All patients were examined twice, once before the exercise programme and once 8 weeks later.
                Improvement in the first group was highly significant after the treatment (p < 0.0001). The second group improved significantly more in some parameters (pain, functional disability, lumbar Schober, progressive isoinertial lifting evaluation (neck), trunk endurance (flexion-extension)) than did the third group. The third group of patients showed some improvement in fingertip-floor distance, functional disability, modified lumbar Schober and left rotation in 8 weeks, but there were no significant improvements in the other parameters.
                Dynamic lumbar stabilization exercises are an efficient and useful technique in the rehabilitation of patients who have undergone microdiscectomy. They relieve pain, improve functional parameters and strengthen trunk, abdominal and low back muscles. The study design includes a prospective, randomised controlled study comparing total disc replacement (TDR) with posterior fusion. The main objective of this study is to compare TDR with lumbar spinal fusion, in terms of clinical outcome, in patients referred to a spine clinic for surgical evaluation. Fusion is effective for treating chronic low back pain (LBP), but has drawbacks, such as stiffness and possibly adjacent level degradation. Motion-preserving options have emerged, of which TDR is frequently used because of these drawbacks. How the results of TDR compare to fusion, however, is uncertain. One hundred and fifty-two patients with a mean age of 40 years (21-55) were included: 90 were women, and 80 underwent TDR. The patients had not responded to a conservative treatment programme and suffered from predominantly LBP, with varying degrees of leg pain. Diagnosis was based on clinical examination, radiographs, MRI, and in unclear cases, diagnostic injections. Outcome measures were global assessment (GA), VAS for back and leg pain, Oswestry Disability Index, SF36 and EQ5D at 1 and 2 years. Follow-up rate was 100%, at both 1 and 2 years. All outcome variables improved in both groups between preoperative and follow-up assessment. The primary outcome measure, GA, revealed that 30% in the TDR group and 15% in the fusion group were totally pain-free at 2 years (P = 0.031). TDR patients had reached maximum recovery in virtually all variables at 1 year, with significant differences compared to the fusion group. The fusion patients continued to improve and at 2 years had results similar to TDR patients apart from numbers of pain-free. Complications and reoperations were similar in both groups, but pedicle screw removal as additive surgery, was frequent in the fusion group. One year after surgery, TDR was superior to spinal fusion in clinical outcome, but this difference had diminished by 2 years, apart from (VAS for back pain and) numbers of pain-free. The long-term benefits have yet to be examined. This study was conducted on 90 patients with symptomatic cervical disc disease with one or two-level disc pathology. Clinical and radiological outcome was compared to determine which technique was advantageous for patients with disc disease. Problems related to donor site as well as those related to fusion bed and grafts have stimulated investigators to avoid fusion. Patients were allocated at random for either the ACF (n=50) or the ACD (n=40) procedures. The standard Smith-Robinson technique was performed on all patients in this study. Patients were followed-up clinically and radiologically according to the study protocol. The clinical long-term outcome was comparable in both groups, though those who had ACF were more satisfied. There was significant incidence of kyphosis in the ACD group (P=0.02). Osseous union was slow and less satisfactory with ACD (64%) than with ACF (94%). Pain at the donor site was not a significant problem in the long-term. Hospital stay and operative time was shortened in ACD patients though not significantly. Spondylotic patients were less satisfied with ACD though not significantly. Conclusions. The issue of whether to fuse or not to fuse has not come to an end yet. The technique is still in need of more refinement of disc excision and graft harvesting and shaping, as well as more adequately controlled studies. Until that, ACD has to be limited to those patients with a soft single disc without spondylosis. A randomized clinical trial was carried out to compare the results of open discectomy with those of chemonucleolysis in 151 patients suffering from a disc herniation at L4-5 or L5-S1. All patients fulfilled strict entry criteria; 78 patients underwent open discectomy and 73 were subjected to chemonucleolysis. An increase in radicular pain immediately after treatment was encountered in 16 patients (22%) in the chemonucleolysis group, as compared to none in the discectomy group. The efficacy of discectomy appeared to be definitely superior to that of chemonucleolysis. Within a follow-up period of 1 year, 18 patients (25%) required open discectomy following failed chemonucleolysis; two patients (3%) in the discectomy group needed a second operation. Open discectomy following previous chemonucleolysis was successful in only 44% of cases. Comparison of the final results of the two modes of treatment 12 months after the last intervention (including second treatment) did not reveal any significant differences. The duration of the preoperative symptoms, the level of disc herniation, and the leakage of contrast medium out of the disc appeared to be of no relevance to the final outcome. The complication rates in both treatment groups were low. A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial.
                The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement, using the CHARITE artificial disc (DePuy Spine, Raynham, MA), with anterior lumbar interbody fusion, for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment.
                Reported results of lumbar total disc replacement have been favorable, but studies have been limited to retrospective case series and/or small sample sizes.
                Three hundred four (304) patients were enrolled in the study at 14 centers across the United States and randomized in a 2:1 ratio to treatment with the CHARITE artificial disc or the control group, instrumented anterior lumbar interbody fusion. Data were collected pre- and perioperatively at 6 weeks and at 3, 6, 12, and 24 months following surgery. The key clinical outcome measures were a Visual Analog Scale assessing back pain, the Oswestry Disability Index questionnaire, and the SF-36 Health Survey.
                Patients in both groups improved significantly following surgery. Patients in the CHARITE artificial disc group recovered faster than patients in the control group. Patients in the CHARITE artificial disc group had lower levels of disability at every time interval from 6 weeks to 24 months, compared with the control group, with statistically lower pain and disability scores at all but the 24 month follow-up (P < 0.05). At the 24-month follow-up period, a significantly greater percentage of patients in the CHARITE artificial disc group expressed satisfaction with their treatment and would have the same treatment again, compared with the fusion group (P < 0.05). The hospital stay was significantly shorter in the CHARITE artificial disc group (P < 0.05). The complication rate was similar between both groups.
                This prospective, randomized, multicenter study demonstrated that quantitative clinical outcome measures following lumbar total disc replacement with the CHARITE artificial disc are at least equivalent to clinical outcomes with anterior lumbar interbody fusion. These results support earlier reports in the literature that total disc replacement with the CHARITE artificial disc is a safe and effective alternative to fusion for the surgical treatment of symptomatic disc degeneration in properly indicated patients. The CHARITE artificial disc group demonstrated statistically significant superiority in two major economic areas, a 1-day shorter hospitalization, and a lower rate of reoperations (5.4% compared with 9.1%). At 24 months, the investigational group had a significantly higher rate of satisfaction (73.7%) than the 53.1% rate of satisfaction in the control group (P = 0.0011). This prospective randomized multicenter study also demonstrated an increase in employment of 9.1% in the investigational group and 7.2% in the control group. Epidural scarring is one of the possible complications after lumbar disc surgery. Perineural scar tissue has been considered responsible for recurrent neurological symptoms in patients operated on for disc herniation and leads to a high rate of unsatisfactory results. In addition, postoperative scars may increase the technical difficulty and risk of subsequent procedures. Various materials have been used in animal studies to try to affect the degree of epidural scar tissue with controversial results. In particular, free fat transplantation has been described to reduce the degree of intraspinal scar tissue. We therefore performed a prospective, double-blind, randomized study comparing clinical and social factors of patients being operated on for the first time for lumbar disc herniation. A total of 92 patients received an implantation of autologous fat graft, 94 did not. After a median of 24.2 months after their surgery, an objective examinator compared various clinical parameters and the social situation of patients in both groups without knowing the operation method used. We found no significant differences between the fat-graft group and the control group regarding either the clinical outcome or the social aspects. The authors report 66 patients with signs, symptoms, and a myelographic abnormality of herniated lumbar disc, who were not responsive to conservative treatment. The discs were injected at random with either chymopapain or a placebo. Neither patient nor surgeon knew which agent was used until after the results had been tabulated. Unless early laminectomy was necessary for intractable pain, all patients were followed for 2 months or more. There was no statistically significant difference in incidence or quality of improvement between the two groups: chymopapain was successful in 58% while placebo was successful in 49% (p = 0.15). Early results from this study indicate that most, if not all, of the putative effectiveness of chemonucleolysis probably derives from a placebo effect. The magnitude of the tissue damage from surgery impacts the trauma response. This response is proportional to the severity of surgical stress. Systemic cytokines are recognized as markers of postoperative tissue trauma. Microendoscopic discectomy (MED) recently has become popular for treating lumbar disc herniations, and is associated with favorable clinical outcomes compared with open discectomy (OD). This study postulates that MED is a less traumatic procedure, and therefore has a lower surgical stress response compared to OD. In this study, a quantitative comparison of the overall effects of surgical trauma resulting from MED and OD was performed through analyzing patient systemic cytokines response. From April, 2002 to June, 2003, 22 consecutive patients who had symptomatic lumbar disc herniations were prospectively randomized to undergo either intracanalicular MED (N=10) or OD (N=12). In this study, the Vertebroscope System (Zeppelin, Pullach, Germany) was used to perform the endoscopic discectomy procedure in all MED patients. Serum levels of tumor necrosis factor-alpha (TNF-alpha), Interleukin-1beta (IL-1beta), Interleukin-6 (IL-6), and Interleukin-8 (IL-8) were measured before surgery and at 1, 2, 4, 8 and 24h after surgery using an enzyme-linked immunosorbent assay. Serum C-reactive protein (CRP) was measured at the same time interval. The results showed the MED patients had shorter postoperative hospital stay (mean, 3.57+/-0.98 vs. 5.92+/-2.39 days, p=0.025) and less intraoperative blood loss (mean, 87.5+/-69.4 vs. 190+/-115 ml, p=0.042). The operating length, including the set-up time, was longer in the MED group (mean, 109+/-35.9 vs. 72.1+/-17.8 min, p=0.01). The mean size of skin incision made for the MED patients was 1.86+/-0.13 cm (range 1.7-2.0 cm); and 6.3+/-0.98 cm for the OD patients (range 5.5-8 cm), p=0.001. The patients' pain severity of the involved limbs on 10-point Visual Analog Scale before operation in MED group was 7.5+/-0.3 (range 6-9) and 8+/-0.2 (range 7-9) in OD group, p=0.17; and after surgery, 1.5+/-0.2 (range 1-2) in MED group and 1.4+/-0.1 (range 1-3) in OD group, p=0.91. CRP levels peaked at 24h in both groups, and OD patients displayed a significantly greater postoperative rise in serum CRP (mean, 27.78+/-15.02 vs. 13.84+/-6.25mg/l, p=0.026). Concentrations of TNF-alpha, IL-1beta, and IL-8 were detected only sporadically. Serum IL-6 increased less significantly following MED than after OD. In the MED group, IL-6 level peaked 8h after surgery, with the response statistically less than in the open group (mean, 6.27+/-5.96 vs. 17.18+/-11.60 pg/ml, p=0.025). A statistically significant correlation was identified between IL-6 and CRP values (r=0.79). Using the modified MacNab criteria, the clinical outcomes were 90% satisfactory (9/10) in MED patients and 91.6% satisfactory (11/12) in OD patients at a mean 18.9 months (range 10-25) follow-up. Based on the current data, surgical trauma, as reflected by systemic IL-6 and CRP response, was significantly less following MED than following OD. The difference in the systemic cytokine response may support that the MED procedure is less traumatic. Moreover, our MED patients had achieved satisfactory clinical outcomes as the OD patients at a mean 18.9 months follow-up after surgery. A prospective randomized trial with assessment of treatment results by an independent observer and by patient questionnaire.
                This study evaluated whether implantation of polymethylmethacrylate after anterior cervical discectomy improved clinical results and whether polymethylmethacrylate provided a solid bony union with preservation of anatomical relations of the cervical spine.
                Discectomy without fusion disturbs anatomical relations of the cervical spine. Use of an autologous bone graft frequently causes donor-site complications. Therefore, synthetic materials such as polymethylmethacrylate have been used instead of bone to obtain spinal fusion. Whether these implants improve the clinical results of anterior discectomy is unknown. In addition, the radiological follow-up of discectomy with polymethylmethacrylate has hardly been investigated.
                Between April, 1986, and April, 1990, all patients with radiologically proven cervical disc pathology and a radicular syndrome were eligible for this study. The primary endpoint of the study was the clinical result after 2 years. Assessment of the result was rated both by an independent observer using Odom's criteria and by the patient using a written questionnaire. Before surgery and during follow-up, radiographs were obtained.
                Two patients died during follow up. A good result was obtained in 28 of 42 patients (70%) treated with polymethylmethacrylate and in 30 of 39 patients (77%) of patients treated with discectomy only. Pre-operative neck pain subsided earlier if polymethylmethacrylate was used, but the difference was temporary and clinically insignificant. The use of polymethylmethacrylate resulted in a significant lower bony union rate. Polymethylmethacrylate frequently migrated into adjacent vertebrae.
                No relevant clinical differences between treatments were found. The radiological results of anterior discectomy with polymethylmethacrylate were inferior to those of discectomy only. Based on these results, the use of polymethylmethacrylate to obtain fusion after anterior discectomy is not recommended. After 40 years of experience with anterior cervical operations, whether to fuse is still controversial. This study seeks to answer this question.
                In this prospective randomized study, we operated on 91 patients with single-level cervical root compression using three different methods: 1) discectomy without fusion, 2) fusion with autologous bone graft, and 3) fusion with autologous bone graft plus plating.
                After 4 years of follow-up, the radiological results indicated that complete bony union was achieved in almost all cases. A slight kyphosis developed in 62.5% of the patients who had undergone discectomy, 40% of the patients who had undergone fusion, and 44% of the patients who had undergone fusion plus plating (not significant). The clinical outcomes were good for 76% of the patients who had undergone discectomy, 82% who had undergone fusion, and 73% who had undergone fusion plus plating. The outcomes were poor in 0, 4, and 4%, respectively (not significant).
                According to this study, satisfactory results can be achieved by performing simple discectomy to treat single-level cervical root compressive disease. This study represents the first 39 patients with at least 6-month follow-up enrolled in a prospective randomized Food and Drug Administration study evaluating the safety and efficacy of the ProDisc II versus the control, a 360 degrees lumbar spinal fusion. Data were collected preoperatively and at 6 weeks, 3 months, and 6 months postoperatively. Visual Analog Scale (VAS), Oswestry Low Back Pain Disability Questionnaire (ODQ), and patient satisfaction rates were evaluated at these intervals, as well as range of motion, return to work, and recreational and ambulatory status. There were 28 ProDisc patients and 11 who underwent fusion. Six patients had two-level surgery. Estimated blood loss (ProDisc = 69 mL versus fusion = 175 mL) and operative time (ProDisc = 75 minutes versus fusion = 219 minutes) were significantly different (P < 0.01). Hospital stays were shorter (ProDisc = 2.1 days versus fusion = 3.5 days [P < 0.01]) for ProDisc patients. There was a significantly greater reduction in the ODQ scores at 3 months in the ProDisc group compared with the fusion group (P < 0.05). No difference was noted in VAS. A trend was identified at 6 months in patient satisfaction rates favoring ProDisc versus fusion (P = 0.08), and motion was significantly improved in ProDisc patients compared with the fusion group (P = 0.02). Ambulatory status as well as recreational activity improved faster in the ProDisc group. The data suggest that total disc arthroplasty may be an attractive option as opposed to lumbar fusion for the surgical treatment of disabling mechanical low back pain secondary to lumbar disc disease. The aim of this prospective study was to examine the one-year postoperative results in patients operated on for lumbar disc herniation randomized in two groups: one with comprehensive rehabilitation and the other taken care of by normal care facilities. A total of 212 patients without any previous spinal operations comprised the final study group. The physiatrist, the surgeon, the social worker, and the psychologist performed the handicap evaluation according to the occupation handicap scales of the WHO. The handicap was evaluated for two phases: before the onset of acute sciatica leading to operation and one year after operation. No significant differences in handicap distribution between the intervention and normal care groups were seen. The postoperative handicap correlated highly significantly with preoperative handicap for both groups. More than half (57%) of all the patients returned to work within two months of the operation. The amount of sick leaves did not differ significantly between the intervention and normal care groups. A total of 15 persons (7%) retired during the postoperative year. Sixty-two patients with chronic low back pain occurring 14-60 months after undergoing discectomy for the first time were randomized to two physical treatment groups: 24 sessions of intensive dynamic back exercises with hyperextension or 24 sessions of intensive dynamic back exercises without hyperextension. At the conclusion of therapy and at one-year follow-up, no difference was seen between the randomized groups, with regard to the combined assessments of pain, disability and objective measurements. A difference for back exercises without hyperextension to be superior to the other treatment regimen was statistically significant at the three-month follow-up. In the patient's qualitative assessment of treatment outcome there were seen no significant differences between back exercises with or without hyperextension. There was a similar and significant improvement of the isometric endurance of back muscles in both groups, but the flexibility of the spine was significantly improved only in the group using hyperextension exercises. The overall response rate of an earlier published investigation was reproduced. It is concluded that chronic back patients after first time discectomy may benefit from an intensive rehabilitation protocol including intensive exercises. The added use of hyperextension exercises does not confer any independent benefit. Furthermore, the training had to continue for more than 2-3 months before a statistical significant decrease in back pain was reported in the patient pain diary.
Surgical discectomy for carefully selected patients with sciatica due to lumbar disc prolapse provides faster relief from the acute attack than conservative management, although any positive or negative effects on the lifetime natural history of the underlying disc disease are still unclear. Microdiscectomy gives broadly comparable results to open discectomy. The evidence on other minimally invasive techniques remains unclear (with the exception of chemonucleolysis using chymopapain, which is no longer widely available).