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.
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: Retrospective subgroup analysis of prospectively collected data according to treatment received.
OBJECTIVE: The purpose of this study is to determine whether the duration of symptoms affects outcomes after the treatment of spinal stenosis (SS) or degenerative spondylolisthesis (DS).
SUMMARY OF BACKGROUND DATA: The Spine Outcomes Research Trial (SPORT) study was designed to provide scientific evidence on the effectiveness of spinal surgery versus a variety of nonoperative treatments.
METHODS: An as-treated analysis was performed on the patients enrolled in SPORT for the treatment of SS or DS. A comparison was made between patients with SS with 12 or fewer months' (n = 405) and those with more than 12 months' (n = 227) duration of symptoms. A comparison was also made between patients with DS with 12 or fewer months' (n = 397) and those with more than 12 months' (n = 204) duration of symptoms. Baseline patient characteristics were documented. Primary and secondary outcomes were measured at baseline and at regular follow-up time intervals up to 4 years. The difference in improvement among patients whose surgical or nonsurgical treatment began less than or greater than 12 months after the onset of symptoms was measured. In addition, the difference in improvement with surgical versus nonsurgical treatment (treatment effect) was determined at each follow-up period for each group.
RESULTS: At final follow-up, there was significantly less improvement in primary outcome measures in SS patients with more than 12 months' symptom duration. Primary and secondary outcome measures within the DS group did not differ according to symptom duration. There were no statistically significant differences in the treatment effect of surgery in SS or DS patients.
CONCLUSION: Patients with SS with fewer than 12 months of symptoms experienced significantly better outcomes with surgical and nonsurgical treatment relative to those with symptom duration greater than 12 months. There was no difference in the outcome of patients with degenerative spondylolisthesis according to symptom duration.
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.
