A prospective, randomized study comparing the results of open discectomy with those of video-assisted arthroscopic microdiscectomy. [Multicenter randomized double-blind study of triamcinolone hexacetonide versus chymopapain in the treatment of disk lumbosciatica. Initial results at 6 months]. Report of a controlled clinical trial comparing automated percutaneous lumbar discectomy and microdiscectomy in the treatment of contained lumbar disc herniation. Chemonucleolysis versus discectomy: a randomized multicenter trial. A randomized, double-blind study to compare low-dose with standard-dose chymopapain in the treatment of herniated lumbar intervertebral discs. The effect of interposition membrane on the outcome of lumbar laminectomy and discectomy. First-time operation for lumbar disc herniation with or without free fat transplantation. Prospective triple-blind randomized study with reference to clinical factors and enhanced computed tomographic scan 1 year after operation. Percutaneous endoscopic discectomy: surgical technique and preliminary results compared to microsurgical discectomy. Outcome after lumbar sequestrectomy compared with microdiscectomy: a prospective randomized study. Lumbar disc herniation. A controlled, prospective study with ten years of observation. Surgery versus chemonucleolysis for herniated lumbar discs. A prospective study with random assignment. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. [Comparative study of surgery and chemonucleolysis in the treatment of sciatica caused by a herniated disk]. Prevention of peridural fibrosis: current methodologies. Prevention of recurrent radicular pain after lumbar disc surgery: a prospective study. Safety and efficacy of chymopapain (Discase) in the treatment of sciatica due to a herniated nucleus pulposus. Results of a randomized, double-blind study. Discectomy strategies for lumbar disc herniation: results of the LAPDOG trial. Chemonucleolysis and automated percutaneous discectomy--a prospective randomized comparison. [Comparative study of disk surgery with or without microscopy. A prospective study of 80 cases]. Results of applying ADCON-L gel after lumbar discectomy: the German ADCON-L study. A prospective randomized trial of chemonucleolysis and conventional disc surgery in single level lumbar disc herniation. Treatment of lumbar disc herniation: epidural steroid injection compared with discectomy. A prospective, randomized study. [Clinical study of prevention of epidural scar and adhesion with polylactic acid membrane]. Less systemic cytokine response in patients following microendoscopic versus open lumbar discectomy. A controlled study of microsurgical versus standard lumbar discectomy. Double-blind evaluation of intradiscal chymopapain for herniated lumbar discs. Early results. Chymopapain for the treatment of intervertebral disc herniation. A preliminary report of a double-blind study. Lumbar micro disc surgery with and without autologous fat graft. A prospective randomized trial evaluated with reference to clinical and social factors. Does microscopic removal of lumbar disc herniation lead to better results than the standard procedure? Results of a one-year randomized study. Double-blind evaluation of collagenase injections for herniated lumbar discs. A comparison of surgery and chemonucleolysis in the treatment of sciatica. A prospective randomized trial. Five-year results from chemonucleolysis with chymopapain or collagenase: a prospective randomized study. [Double-blind study of the treatment of disc lumbosciatica by chemonucleolysis]. Reduction of leg pain and lower-extremity weakness for 1 year with Oxiplex/SP gel following laminectomy, laminotomy, and discectomy. [Treatment of lumbar disk hernia by intra-disk injection of chymopapain or triamcinolone hexacetonide. Comparative study of 80 cases]. Safety and efficacy of chymopapain (Chymodiactin) in herniated nucleus pulposus with sciatica. Results of a randomized, double-blind study.
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. nan 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. 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. Postoperative low-back pain and spasm are the main drawbacks of chymopapain chemonucleolysis. To investigate if low-dose chymopapain could reduce this adverse reaction, without modifying the efficacy, 118 patients with persistent low-back and radicular pain due to a lumbar disc herniation underwent chemonucleolysis. 60 patients were randomly selected to receive 2 mL of standard-dose chymopapain (4,000 units) and 58 to receive 2 mL of low dose (2,000 units). The clinical outcome was assessed on study days 1, 30, and 60, and after 1 year by physicians who were unaware of the treatment, and on the basis of the patients' self evaluation. At day 60, Chemonucleolysis was rated as successful in 81% of the cases by the investigator and in 80% by the patient's self assessment. The percentage of good results was remarkably similar in the two treatment groups and this finding was confirmed after 1 year. There was some evidence that the low-dose treatment resulted in less frequent postoperative back pain but the difference was not statistically significant. Moreover, a comparable incidence of acute low-back pain and spasm was observed in the two treatment groups. Low-dose chemonucleolysis appears to be as effective as the standard dose, but the use of 2,000 units does not significantly lower the postoperative back pain. This study evaluated clinical and magnetic resonance imaging differences of patients treated surgically for lumbar disc herniation. Clinical follow-up and magnetic resonance imaging evaluation of epidural fibrosis were used to assess patient outcome.
                The purpose of this study was to evaluate the difference in clinical outcome with either free-fat graft, Gelfoam, or no interposition membrane placed in the laminectomy defect after nerve root decompression.
                Epidural fibrosis has been considered a cause of recurrent symptoms after lumbar laminectomy, and numerous materials have been evaluated for prophylaxis of the "laminectomy membrane." These have been mainly histologic and animal studies with no data correlating clinical symptoms and postoperative epidural scar formation.
                One hundred fifty-six patients who were treated surgically for lumbar disc herniation were randomly assigned to one of three groups and followed prospectively for at least 1 year. Thirty-three of these patients were received magnetic resonance imaging evaluations after 6 months by an independent radiologist who graded the amount of epidural scar formation. The patients were assessed at 1 year and given a rating of excellent, good, fair, or poor, and the scar was graded as none, minimal, or moderate.
                Although 97% of all patients improved, 83% were rated excellent or good. There were no statistical differences between the three groups clinically and radiographically. Patients with workers compensation had a statistically significant lower success rate (P < 0.001).
                Clinical outcome after lumbar disc surgery does not correlate with the use or type of interposition membrane used to prevent epidural fibrosis. This prospective triple-blind randomized study of 99 patients concerned the use of free fat transplantation for operation for lumbar disc herniation.
                To subsequently examine the patients after median 376 days who were subjected to enhanced computed tomographic scan.
                In studies on experiments with animals, the degree of intraspinal scar tissue has shown to be reduced in connection with free fat transplantation. Scar tissue is seen frequently after operation for lumbar disc herniation, but it is uncertain whether the scar tissue can lead to symptoms.
                The clinical outcome was scored using the Low Back Pain Rating Scale. Enhanced computed tomographic scan was assessed regarding the degree of scar tissue and survival of fat transplant.
                There was no different in the clinical outcome between the two groups. Significantly fewer patients had dural scarring in the group who had a fat transplantation, but there was no difference regarding the degree of radicular scarring. The transplant was shown on computed tomographic scan at the follow-up examination in 66% of the patients who had a fat transplantation.
                Free fat transplantation can reduced the degree of dural scar tissue after operation for lumbar disc herniation but does not result in a clinically better outcome. 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. 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. Two hundred eighty patients with herniated lumbar discs, verified by radiculography, were divided into three groups. One group, which mainly will be dealt with in this paper, consisted of 126 patients with uncertain indication for surgical treatment, who had their therapy decided by randomization which permitted comparison between the results of surgical and conservative treatment. Another group comprising 67 patients had symptoms and signs that beyond doubt, required surgical therapy. The third group of 87 patients was treated conservatively because there was no indication for operative intervention. Follow-up examinations in the first group were performed after one, four, and ten years. The controlled trial showed a statistically significant better result in the surgically treated group at the one-year follow-up examination. After four years the operated patients still showed better results, but the difference was no longer statistically significant. Only minor changes took place during the last six years of observation. 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. For patients with lumbar disk herniation, the Spine Patient Outcomes Research Trial (SPORT) randomized trial intent-to-treat analysis showed small but not statistically significant differences in favor of diskectomy compared with usual care. However, the large numbers of patients who crossed over between assigned groups precluded any conclusions about the comparative effectiveness of operative therapy vs usual care.
                To compare the treatment effects of diskectomy and usual care.
                Prospective observational cohort of surgical candidates with imaging-confirmed lumbar intervertebral disk herniation who were treated at 13 spine clinics in 11 US states and who met the SPORT eligibility criteria but declined randomization between March 2000 and March 2003.
                Standard open diskectomy vs usual nonoperative care.
                Changes from baseline in the Medical Outcomes Study Short-Form Health Survey (SF-36) bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons/MODEMS version).
                Of the 743 patients enrolled in the observational cohort, 528 patients received surgery and 191 received usual nonoperative care. At 3 months, patients who chose surgery had greater improvement in the primary outcome measures of bodily pain (mean change: surgery, 40.9 vs nonoperative care, 26.0; treatment effect, 14.8; 95% confidence interval, 10.8-18.9), physical function (mean change: surgery, 40.7 vs nonoperative care, 25.3; treatment effect, 15.4; 95% CI, 11.6-19.2), and Oswestry Disability Index (mean change: surgery, -36.1 vs nonoperative care, -20.9; treatment effect, -15.2; 95% CI, -18.5. to -11.8). These differences narrowed somewhat at 2 years: bodily pain (mean change: surgery, 42.6 vs nonoperative care, 32.4; treatment effect, 10.2; 95% CI, 5.9-14.5), physical function (mean change: surgery, 43.9 vs nonoperavtive care 31.9; treatment effect, 12.0; 95% CI; 7.9-16.1), and Oswestry Disability Index (mean change: surgery -37.6 vs nonoperative care -24.2; treatment effect, -13.4; 95% CI, -17.0 to -9.7).
                Patients with persistent sciatica from lumbar disk herniation improved in both operated and usual care groups. Those who chose operative intervention reported greater improvements than patients who elected nonoperative care. However, nonrandomized comparisons of self-reported outcomes are subject to potential confounding and must be interpreted cautiously.
                clinicaltrials.gov Identifier: NCT00000410. nan 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. Postoperative epidural fibrosis is a major causative factor of low-back pain even if microsurgical techniques are adopted to reduce this phenomenon. To prevent the recurrent radicular pain caused by this problem, we utilized adipose tissue drawn from the same patient; at the end of surgical procedure, the fat was placed around the spinal root or the dural sac. This procedure was evaluated by a prospective, randomised study.
                From 180 patients operated on for lumbar discectomy between January 2000 to December 2001, 74 were enclosed in the study. In 37 patients, the spinal root was covered by autologous fat (group A), in the other 37 (control group, B), this procedure was not adopted. One year after surgery, all the patients were evaluated with clinical and radiological (Magnetic Resonance Imaging) follow-up. Only two patients were lost to follow-up.
                71% of the patients in group A had 100% of clinical and radiological post-operative outcome score; this result was obtained only in 35% of the patients in group B. A clinical score evaluating pain syndrome (from grade 0 to 5) and a radiological score evaluating postoperative fibrosis (from grade 0 to 4) was adopted. Therefore, group A had best outcome as compared to control group.
                The authors found a positive effect in the reconstruction of epidural fat with autograft of adipose tissue to prevent postoperative scarring and failed-back syndrome related to postoperative fibrosis. 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. 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. 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. The authors report a randomized prospective study of 80 patients operated for lumbar disc herniation. In one group of patients, the operator used a microscopic discectomy, in the other group, the surgery was performed through an interlaminar approach without microscopic magnification. All patients were operated on by the same surgeon. The results have been evaluated by a blind neurosurgeon after 12 to 18 months. 90% patients of the two groups have an excellent or a good outcome following the criteria of Mac Nab. There is no difference, regarding the outcome, between microscopic and non-microscopic removal of disc herniation. Using the microscope does not influence the operating time, the post operative inpatient stay and the time off-work. The authors conclude that the use of the microscope, can facilitate the operation and give a better visual comfort, but does not improve the final results. Failed-back syndrome is still an unsolved problem. Use of ADCON-L gel, already commercially available, has been proven to reduce postoperative scarring in animal experiments. The authors of two controlled clinical studies have also shown positive results when applying the gel. They did not, however, establish patient-oriented endpoints. The authors report a study of ADCON-L in which they focus on patient-oriented endpoints.
                Patients with lumbar disc herniation were randomized to an ADCON-L-treated or control group. Therapeutic success was evaluated using the validated Hannover Questionnaire on Activities of Daily Living (FFbH) 6 months after surgery. The study took place between November 14. 1996, and April 20, 1998, in eight neurosurgical centers in Germany. A total of 398 patients was recruited; 41 patients dropped out during follow up. The mean functional FFbH score (100 points = all activities are possible without problem; 0 points = no activity is possible) was 78.5 points in the ADCON-L-treated group compared with 80 points in the control group. Furthermore, in terms of secondary outcome variables, the ADCON-L group did not have an advantage over the control group. Only the mean magnetic resonance imaging score showed a slight advantage of ADCON-L over the control group.
                The authors found no positive effect of treatment with ADCON-L gel in patients in whom one-level lumbar microdiscectomy was performed. Because of its rather large sample size and its homogeneity, the study had sufficient power to detect even small differences between the two groups. 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. Epidural steroid injection is a low-risk alternative to surgical intervention in the treatment of lumbar disc herniation. The objective of this study was to determine the efficacy of epidural steroid injection in the treatment of patients with a large, symptomatic lumbar herniated nucleus pulposus who are surgical candidates.
                One hundred and sixty-nine patients with a large herniation of the lumbar nucleus pulposus (a herniation of >25% of the cross-sectional area of the spinal canal) were followed over a three-year period. One hundred patients who had no improvement after a minimum of six weeks of noninvasive treatment were enrolled in a prospective, non-blinded study and were randomly assigned to receive either epidural steroid injection or discectomy. Evaluation was performed with the use of outcomes scales and neurological examination.
                Patients who had undergone discectomy had the most rapid decrease in symptoms, with 92% to 98% of the patients reporting that the treatment had been successful over the various follow-up periods. Only 42% to 56% of the fifty patients who had undergone the epidural steroid injection reported that the treatment had been effective. Those who did not obtain relief from the injection had a subsequent discectomy, and their outcomes did not appear to have been adversely affected by the delay in surgery resulting from the trial of epidural steroid injection.
                Epidural steroid injection was not as effective as discectomy with regard to reducing symptoms and disability associated with a large herniation of the lumbar disc. However, epidural steroid injection did have a role: it was found to be effective for up to three years by nearly one-half of the patients who had not had improvement with six or more weeks of noninvasive care. To investigate the clinical effect of polylactic acid membrane in prevention of epidural scar and adhesion.
                From July 1998 to April 2000, 62 patients with lumbar disc herniation were randomly assigned into two groups. All were treated surgically with discectomy by fenestration or laminectomy. One group were placed with a thin of polylactic acid membrane covering the interlaminar space(n = 32). The thickness of the film was 0.1 mm. The other group was blank control(n = 30). After 2 weeks of operation, we observed the local and systemic reactions. After 6 months clinical symptoms were revaluated and the degrees of epidural scar and adhesion were determined by CT scans.
                After 2 weeks, we found no adverse systemic reactions in all patients. Wound healing was excellent. No abnormalities of hepatic and renal functions as well as blood for routine were found. Temperature after operation was normal. After 6 months, the curative effects were as follows in experimental group and in control group: excellent in 27 patients and in 24 patients, good in 4 patients and in 4 patients, fair in 1 patient and in 1 patient, and poor in 0 patient and in 1 patient, respectively. There are no significant difference between two groups. The CT scans showed no adhesion between the epidural scar and the dural sac in all patients of experimental group. There existed various extents of adhesion in control group.
                The results demonstrate that the polylactic acid membrane can effectively prevent the epidural scar adhesion with a good biocompatibility and no toxity. Its clinical application was promising. 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. 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. 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. Sixty patients with unilateral sciatica resulting from lumbar intervertebral disc herniation were entered into a double-blind study. All patients had failed to respond to conservative management, and the diagnosis had been confirmed by metrizamide myelography. Following a randomized schedule, 30 patients had intradiscal injections of chymopapain and 30 patients had intradiscal injections of an equivalent volume of normal saline solution. Complete relief of sciatica was obtained in 63% of patients treated with chymopapain, compared with 27% of saline-injected patients. Six weeks after the injection, 73% of patients treated with chymopapain and 37% of patients treated with saline solution considered that the treatment was successful. The success rate at six months was 80% for patients treated with chymopapain and 57% for saline-injected patients. From the preliminary results of this study, chymopapain is recommended for the treatment of sciatica from intervertebral disc herniation when conservative measures have failed and before disc fragment excision is considered. 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. Sixty patients with single-level lumbar disc herniation confirmed by computerized tomography were studied in a randomized prospective study. The aim was to see if there was any difference between the microscopic removal of a disc herniation and the standard procedure. All patients were operated on by the same surgeon by either method. They were all followed up by an impartial observer at 3 weeks, 2 months, 6 months, and 1 year. There were no differences between the groups regarding perioperative bleeding, complications, inpatient stay, time off work, or end result. The authors concluded that the decision to use the operating microscope may be left to the surgeon, because it had no effect on the short-term results or those at 1 year. A randomized clinical trial of 30 patients with refractory lumbar disc disease with evidence of a herniation at a single intervertebral space on the myelogram is presented. Collagenase or a saline placebo was injected into the affected disc. Lack of pain reduction or lack of functional improvement was considered a therapeutic failure. Patients who failed to respond to the placebo could subsequently receive a collagenase injection. Thirty-three percent (33%) of the 15 patients who received a placebo and 80% of the 15 patients who received collagenase were rated successful 8 weeks after injection. The study demonstrates a statistically significant effectiveness of collagenase in the treatment of herniated lumbar disc disease. 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. A 5-year clinical follow-up assessment of a prospective randomized study of chemonucleolysis using chymopapain (4000 IU) or collagenase (400 ABC units) was performed.
                Intradiscal therapy can be performed for patients with contained discs by chemonucleolysis, percutaneous discectomy, or laser ablation. The oldest intradiscal therapy is chemonucleolysis with chymopapain.
                The purpose of this study was to compare prospectively the efficacy of chymopapain and collagenase for intradiscal injection.
                In this study, 100 patients with indication for intradiscal therapy were prospectively randomized to treatment with either chymopapain or collagenase. All the injections were performed by the double-needle technique with the patient under general anesthesia. The mean age of the patients was 35.5 years in the chymopapain group and 38 years in the collagenase group. An equal number of injections was performed at L4-L5 and L5-S1.
                After 5 years, good and excellent results were observed in 72% of the chymopapain group and 52% of the collagenase group when the surgically treated and lost patients were graded as poor. Using a scale of 0 (no pain) to 10 (intractable pain), the pain level dropped from 8.5 to 0.7 in the chymopapain group and from 8.6 to 0.9 in the collagenase group. Microdiscectomy at the injected level was required for 23 patients (14 in the collagenase group and 9 in the chymopapain group).
                After 5 years, no deterioration had occurred, as compared with the 1-year follow-up assessment. Chymopapain has proved to be safe, with one minor anaphylactic reaction, and effective even over the long term. Collagenase may need further study and cannot be recommended at this time. A randomized, double-blind study was made of 39 patients with discolumbar hernias that were unresponsive to medical treatment. They were treated either by nucleolysis with chymopapain (4 000 U of discase), or by discography followed by injection of distilled water as a placebo. After one month, treatment was found to be successful in 55% of cases undergoing nucleolysis and in 26% of cases receiving the placebo. The results after 3 months were 65% and 42%. respectively. After one month, the intensity of lumbar pain decreased by 44% on average in the group treated by chymopapain, and by 0% in the placebo group. Radicular pain decreased by 53% in the first group and by 26% in the placebo group, and improvement in Lasègue's sign was 51% and 20%, respectively. Analgesic treatment was reduced in patients treated by chymopapain: 65% of patients in the first group report some or much improvement in their sciatica, whereas this figure was 26% in the placebo group (p less than 0.02). Contralateral sciatica was observed in 3 patients of the placebo group. The average give in the disc one month after nucleolysis was 34% in the chymopapain group and 27% in the placebo group, without correlation with the clinical result. On average, patients were monitored for one year after nucleolysis, and during this year 6 patients from the chymopapain group were operated upon, compared with 10 patients from the placebo group. Although these results are at the limit of statistical significance because of the number of patients studied, they confirm the innocuousness and effectiveness of chymopapain in the treatment of discolumbar hernias. Although good surgical technique is effective in reducing postoperative epidural fibrosis, compression or tethering of the nerve root may cause recurrent radicular pain and physical impairment. The implantation of a bioresorbable gel on the dura may further decrease the amount of scar formation after surgery and thus improve the patient's ability to perform activities of daily living (ADL). This study is a 12-month evaluation of the safety and effectiveness of Oxiplex/SP Gel (FzioMed, Inc., San Luis Obispo, CA) in the reduction of pain and radiculopathy after lumbar discectomy.
                A pilot randomized single-blind multicenter clinical trial was conducted to evaluate the performance of Oxiplex/SP Gel in patients who underwent surgery for unilateral herniation of the lumbar disc at L4-5 or L5-S1. Eighteen patients with severe leg pain and lower-extremity weakness (11 women and seven men) were randomly assigned intraoperatively to receive the gel at the conclusion of surgery (treatment group) or to undergo surgery alone (control group). Self-assessment questionnaires (Lumbar Spine Outcomes Questionnaire) to assess pain, symptoms, and ADL were completed preoperatively and at scheduled postoperative intervals (30 days, 90 days, 6 months, and 12 months). The authors examined the spine and lower extremities of patients scheduled for discectomy to assess neurological function and pain. Treated patients received sufficient Oxiplex/SP Gel (1-3 ml) to coat the nerve root and fill the epidural space. Postoperative clinical evaluations were performed at 30 and 90 days. Patients completed the self-assessment questionnaires at baseline and were contacted by telephone or mail for the completion of the postoperative self-assessment questionnaires. Surgical procedures were well tolerated; no device-related adverse events and no clinically significant laboratory results were reported. The 11 patients with severe leg pain and lower-extremity weakness who were treated with Oxiplex/SP Gel had a reduction in those symptoms at 30 days, 90 days, 6 months, and 12 months after discectomy, compared with the seven control patients who underwent surgery only.
                Oxiplex/SP Gel was easy to use and safe in patients who underwent unilateral discectomy. A greater benefit in clinical outcome measures was seen over the 12-month follow-up period in gel-treated patients. nan A double-blind, randomized trial was conducted to compare the efficacy of intradiskal injection of chymopapain (Chymodiactin) with injection of placebo in patients with a herniated lumbar disk. Patients were randomly assigned to either placebo or drug regimens and followed up for six months. The primary measure of performance was agreement by patient and surgeon that further intervention was not necessary. At any time that patient and investigator agreed that treatment had failed, the patient was classified as a failure and the treatment code was broken. Of 53 placebo-treated patients, 31 failed by this criterion. Of 55 drug-treated patients, 15 failed. Placebo-treated patients who failed were allowed to receive drug treatment, and 29 (91%) of 32 were treated successfully. This study demonstrates that chymopapain is more effective than placebo for treatment of patients with a herniated lumbar disk.
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).