BACKGROUND: Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials.
METHODS: Surgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolisthesis (as confirmed on imaging) were enrolled in either a randomized cohort or an observational cohort at 13 U.S. spine clinics. Treatment was decompressive surgery or usual nonsurgical care. The primary outcomes were measures of bodily pain and physical function on the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36) and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and 1 and 2 years.
RESULTS: A total of 289 patients were enrolled in the randomized cohort, and 365 patients were enrolled in the observational cohort. At 2 years, 67% of patients who were randomly assigned to surgery had undergone surgery, whereas 43% of those who were randomly assigned to receive nonsurgical care had also undergone surgery. Despite the high level of nonadherence, the intention-to-treat analysis of the randomized cohort showed a significant treatment effect favoring surgery on the SF-36 scale for bodily pain, with a mean difference in change from baseline of 7.8 (95% confidence interval, 1.5 to 14.1); however, there was no significant difference in scores on physical function or on the Oswestry Disability Index. The as-treated analysis, which combined both cohorts and was adjusted for potential confounders, showed a significant advantage for surgery by 3 months for all primary outcomes; these changes remained significant at 2 years.
CONCLUSIONS: In the combined as-treated analysis, patients who underwent surgery showed significantly more improvement in all primary outcomes than did patients who were treated nonsurgically. (ClinicalTrials.gov number, NCT00000411 [ClinicalTrials.gov].).
STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis. METHODS: Four university hospitals agreed on the classification of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles, nonoperative treatment options, and follow-up protocols. A total of 94 patients were randomized into a surgical or nonoperative treatment group: 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (scale, 0-100). Data on the intensity of leg and back pain (scales, 0-10), as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6, 12, and 24 months. RESULTS: Both treatment groups showed improvement during follow-up. At 1 year, the mean difference in favor of surgery was 11.3 in disability (95% confidence interval [CI], 4.3-18.4), 1.7 in leg pain (95% CI, 0.4-3.0), and 2.3(95% CI, 1.1-3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI, 0.8-14.9) 1.5 in leg pain (95% CI, 0.3-2.8), and 2.1 in back pain (95% CI, 1.0-3.3). Walking ability, either reported or measured, did not differ between the two treatment groups. CONCLUSIONS: Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these differences persist.
BACKGROUND: Management of degenerative spondylolisthesis with spinal stenosis is controversial. Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials.
METHODS: Surgical candidates from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a randomized cohort or an observational cohort. Treatment was standard decompressive laminectomy (with or without fusion) or usual nonsurgical care. The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) bodily pain and physical function scores (100-point scales, with higher scores indicating less severe symptoms) and the modified Oswestry Disability Index (100-point scale, with lower scores indicating less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years.
RESULTS: We enrolled 304 patients in the randomized cohort and 303 in the observational cohort. The baseline characteristics of the two cohorts were similar. The one-year crossover rates were high in the randomized cohort (approximately 40% in each direction) but moderate in the observational cohort (17% crossover to surgery and 3% crossover to nonsurgical care). The intention-to-treat analysis for the randomized cohort showed no statistically significant effects for the primary outcomes. The as-treated analysis for both cohorts combined showed a significant advantage for surgery at 3 months that increased at 1 year and diminished only slightly at 2 years. The treatment effects at 2 years were 18.1 for bodily pain (95% confidence interval [CI], 14.5 to 21.7), 18.3 for physical function (95% CI, 14.6 to 21.9), and -16.7 for the Oswestry Disability Index (95% CI, -19.5 to -13.9). There was little evidence of harm from either treatment.
CONCLUSIONS: In nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically. (ClinicalTrials.gov number, NCT00000409 [ClinicalTrials.gov].).
OBJECT: Interspinous process decompression (IPD) theoretically relieves narrowing of the spinal canal and neural foramen in extension and thus reduces the symptoms of neurogenic intermittent claudication (NIC). The purpose of this study was to compare the efficacy of IPD with nonoperative treatment in patients with NIC secondary to degenerative spondylolisthesis.
METHODS: The authors conducted a randomized controlled study in patients with NIC; they compared the results obtained in patients treated with the X STOP IPD device with those acquired in patients treated nonoperatively. The X STOP implant is a titanium alloy device that is placed between the spinous processes to reduce the canal and foraminal narrowing that occurs in extension. In a cohort of 75 patients with degenerative spondylolisthesis, 42 underwent surgical treatment in which the X STOP IPD device was placed and 33 control individuals were treated nonoperatively. Patients underwent serial follow-up evaluations. The Zurich Claudication Questionnaire (ZCQ), 36-Item Short Form Health Survey (SF-36), and radiographic assessment were used to determine outcomes. Two-year follow-up data were obtained in 70 of 75 patients. Statistically significant improvement in ZCQ and SF-36 scores was seen in X STOP device-treated patients but not in the nonoperative control patients at all postoperative intervals. Overall clinical success occurred in 63.4% of X STOP device-treated patients and only 12.9% of controls. Spondylolisthesis and kyphosis were unaltered.
CONCLUSIONS: The X STOP device was more effective than nonoperative treatment in the management of NIC secondary to degenerative lumbar spondylolisthesis.
OBJECT: This study was conducted to compare the quality of life (QOL) in patients with neurogenic intermittent claudication (NIC) secondary to lumbar spinal stenosis (LSS). Using the 36-Item Short Form (SF-36) questionnaire, the authors compared the results obtained in patients treated with the X STOP Interspinous Process Decompression (IPD) System with those obtained in patients who underwent nonoperative therapies.
METHODS: Patients with LSS were enrolled in a prospective 2-year multicenter study and randomized either to the X STOP or nonoperative group. The SF-36 survey was used to assess the QOL before treatment and at 6 weeks, 6 months, 1 year, and 2 years posttreatment. An analysis of variance was used to compare individual pre- and posttreatment mean SF-36 domain scores between the two groups and within each treatment group. At all posttreatment time points, the authors observed the following: (1) mean domain scores in X STOP-treated patients were significantly greater than those in patients treated nonoperatively, with the exception of the mean General Health (GH), Role Emotional, and Mental Component Summary scores at 2 years; and (2) mean posttreatment domain scores documented in X STOP-treated patients were significantly greater than mean pretreatment scores, with the exception of mean GH scores at 6, 12, and 24 months.
CONCLUSIONS: The results of this study demonstrate that the X STOP device is significantly more effective than nonoperative therapy in improving the QOL in patients with LSS. The results are comparable with those reported in other studies involving traditional decompressive techniques for LSS and suggest that the X STOP implant can provide an effective treatment compared with nonoperative and conventional surgical therapies.
STUDY DESIGN: A randomized, controlled, prospective multicenter trial comparing the outcomes of neurogenic intermittent claudication (NIC) patients treated with the interspinous process decompression system (X STOP) with patients treated nonoperatively.
OBJECTIVE: To determine the safety and efficacy of the X STOP interspinous implant.
SUMMARY OF BACKGROUND DATA: Patients suffering from NIC secondary to lumbar spinal stenosis have been limited to a choice between nonoperative therapies and decompressive surgical procedures, with or without fusion. The X STOP was developed to provide an alternative therapeutic treatment. METHODS.: 191 patients were treated, 100 in the X STOP group and 91 in the control group. The primary outcomes measure was the Zurich Claudication Questionnaire, a patient-completed, validated instrument for NIC.
RESULTS: At every follow-up visit, X STOP patients had significantly better outcomes in each domain of the Zurich Claudication Questionnaire. At 2 years, the X STOP patients improved by 45.4% over the mean baseline Symptom Severity score compared with 7.4% in the control group; the mean improvement in the Physical Function domain was 44.3% in the X STOP group and -0.4% in the control group. In the X STOP group, 73.1% patients were satisfied with their treatment compared with 35.9% of control patients.
CONCLUSIONS: The X STOP provides a conservative yet effective treatment for patients suffering from lumbar spinal stenosis. In the continuum of treatment options, the X STOP offers an attractive alternative to both conservative care and decompressive surgery.
Journal»European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
Patients suffering from neurogenic intermittent claudication secondary to lumbar spinal stenosis have historically been limited to a choice between a decompressive laminectomy with or without fusion or a regimen of non-operative therapies. The X STOP Interspinous Process Distraction System (St. Francis Medical Technologies, Concord, Calif.), a new interspinous implant for patients whose symptoms are exacerbated in extension and relieved in flexion, has been available in Europe since June 2002. This study reports the results from a prospective, randomized trial of the X STOP conducted at nine centers in the U.S. Two hundred patients were enrolled in the study and 191 were treated; 100 received the X STOP and 91 received non-operative therapy (NON OP) as a control. The Zurich Claudication Questionnaire (ZCQ) was the primary outcomes measurement. Validated for lumbar spinal stenosis patients, the ZCQ measures physical function, symptom severity, and patient satisfaction. Patients completed the ZCQ upon enrollment and at follow-up periods of 6 weeks, 6 months, and 1 year. Using the ZCQ criteria, at 6 weeks the success rate was 52% for X STOP patients and 10% for NON OP patients. At 6 months, the success rates were 52 and 9%, respectively, and at 1 year, 59 and 12%. The results of this prospective study indicate that the X STOP offers a significant improvement over non-operative therapies at 1 year with a success rate comparable to published reports for decompressive laminectomy, but with considerably lower morbidity.
SUMMARY OF BACKGROUND DATA: The Spine Patient Outcomes Research Trial (SPORT) was designed to assess the relative efficacy and cost-effectiveness of surgical and nonsurgical approaches to the treatment of common conditions associated with low back and leg pain.
OBJECTIVES: To describe the rationale and design of the SPORT project and to discuss its strengths and limitations.
STUDY DESIGN: Descriptive.
METHODS: First, the authors explain the rationale for embarking on SPORT, i.e., deficiencies in the existing scientific knowledge base for treatment of these conditions. Second, the authors describe the design of SPORT, including topics such as specific aims, participating sites, study population, recruitment and enrollment, study interventions, follow-up, outcomes, statistical analysis, and study governance and organization. Finally, issues that complicate the performance of randomized trials in surgery as they relate to the design and conduct of SPORT are discussed.
RESULTS: The SPORT project is being conducted at 11 clinical centers around the United States. It involves the simultaneous conduct of three multicenter, randomized, controlled clinical trials. The study includes patients with the three most common diagnoses for which spine surgery is performed: intervertebral disc herniation, spinal stenosis, and degenerative spondylolisthesis, and it compares the most commonly used standard surgical and nonsurgical treatments for patients with these diagnoses. By the end of enrollment the authors anticipate a total of 500 patients with intervertebral disc herniation, 370 patients with spinal stenosis, and 300 patients with degenerative spondylolisthesis in the randomized trials. Patients who meet the eligibility criteria but decline to be randomized are invited to participate in an observational cohort study. Patients are being followed for a minimum of 24 months with visits scheduled at 6 weeks and at 3, 6, 12, and 24 months.
CONCLUSIONS: The results of this study will provide high-quality scientific evidence to aid clinical decision-making and improve treatment outcomes for these common, costly, and, in some instances, debilitating conditions.
<b>STUDY DESIGN: </b>A cohort of 100 patients with symptomatic lumbar spinal stenosis, characterized in a previous article, were given surgical or conservative treatment and followed for 10 years.<b>OBJECTIVES: </b>To identify the short- and long-term results after surgical and conservative treatment, and to determine whether clinical or radiologic predictors for the treatment result can be defined.<b>Summary Of Background Data: </b>Surgical decompression has been considered the rational treatment. However, clinical experience indicates that many patients do well with conservative treatment.<b>METHODS: </b>In this study, 19 patients with severe symptoms were selected for surgical treatment and 50 patients with moderate symptoms for conservative treatment, whereas 31 patients were randomized between the conservative (n = 18) and surgical (n = 13) treatment groups. Pain was decisive for the choice of treatment group. All patients were observed for 10 years by clinical evaluation and questionnaires. The results, evaluated by patient and physician, were rated as excellent, fair, unchanged, or worse.<b>RESULTS: </b>After a period of 3 months, relief of pain had occurred in most patients. Some had relief earlier, whereas for others it took 1 year. After a period of 4 years, excellent or fair results were found in half of the patients selected for conservative treatment, and in four fifths of the patients selected for surgery. Patients with an unsatisfactory result from conservative treatment were offered delayed surgery after 3 to 27 months (median, 3.5 months). The treatment result of delayed surgery was essentially similar to that of the initial group. The treatment result for the patients randomized for surgical treatment was considerably better than for the patients randomized for conservative treatment. Clinically significant deterioration of symptoms during the final 6 years of the follow-up period was not observed. Patients with multilevel afflictions, surgically treated or not, did not have a poorer outcome than those with single-level afflictions. Clinical or radiologic predictors for the final outcome were not found. There were no dropouts, except for 14 deaths.<b>CONCLUSIONS: </b>The outcome was most favorable for surgical treatment. However, an initial conservative approach seems advisable for many patients because those with an unsatisfactory result can be treated surgically later with a good outcome.
