Spine Patient Outcomes Research Trial (SPORT): Degenerative Spondylolisthesis With Spinal Stenosis
This study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commonly prescribed treatments (surgery and nonsurgical therapy) works better for specific types of low back pain.
In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) caused by degenerative spondylolisthesis (a condition in which one vertebra, or spinal bone, slips forward on another) with either surgery or nonsurgical methods. This study does not cover the cost of treatment.
Low Back Pain
Procedure: Decompressive laminectomy
Other: Non-surgical treatments
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Degenerative Spondylolisthesis (DS) With Spinal Stenosis (SpS) at L4/L5 Level.|
- Changes in health-related quality of life as measured by the SF-36 health status questionnaire [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ] [ Designated as safety issue: No ]
- Patient satisfaction with treatment [ Time Frame: Baseline, 6 wks, 3 mos, Annually thereafter ] [ Designated as safety issue: No ]
- utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness [ Time Frame: Baseline, 1 yr, 4 yr ] [ Designated as safety issue: No ]
- resource utilization [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ] [ Designated as safety issue: No ]
- cost [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ] [ Designated as safety issue: No ]
|Study Start Date:||March 2000|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Surgery
Decompressive Laminectomy Fusion-Instrumented Fusion-Non-instrumented
Procedure: Decompressive laminectomy
Removal of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosisOther: Non-surgical treatments
Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated. Any non-operative therapies other than these are accepted and collected as data.Procedure: Fusion--Instrumented
In addition to decompressive laminectomy, additional bilateral non-instrumented or instrumented, i.e., posterior pedicle fixation, posterolateral fusion with autogenous bone grafting (utilizing iliac crest harvested from between the tables and/or local bone) will be performed between the transverse processes and the lateral portion of the superior facets of the involved levels.Procedure: Fusion-Non-instrumented
additional bilateral non-instrumented or instrumented, i.e., posterior pedicle fixation, posterolateral fusion with autogenous bone grafting (utilizing iliac crest harvested from between the tables and/or local bone) will be performed between the transverse processes and the lateral portion of the superior facets of the involved levels.
Active Comparator: Non-surgical intervention
Other. Non-surgical treatments
Other: Non-surgical treatments
Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated. Any non-operative therapies other than these are accepted and collected as data.
Low back pain is considered one of the most widely experienced health problems in the U.S. and the world. It is the second most frequent condition, after the common cold, for which patients see a physician or lose days from work. Estimated costs to those who are severely disabled from low back pain range from $30-70 billion annually. Rates of spinal surgery in the U.S. have increased sharply over time, and researchers have documented 15-fold geographic variation in rates of these surgeries. In many cases, where one lives and who one sees for the condition appear to determine the rates of surgery. Despite these trends, there is little evidence proving the effectiveness of these therapies over nonsurgical management.
This study will use the National Spine Network to conduct a multicenter, randomized, controlled trial for the three most common diagnostic groups for which spine surgery is performed: lumbar intervertebral disc herniation (IDH), spinal stenosis (SpS), and spinal stenosis secondary to degenerative spondylolisthesis (DS). This arm of the trial will deal with patients from the third diagnostic group. The study will compare the most commonly used standard surgical treatments to the most commonly used standard nonsurgical treatments. We will conduct the study at 12 sites throughout the United States.
The primary endpoint of the study will be changes in health-related quality of life as measured by the SF-36 health status questionnaire. Secondary endpoints will include patient satisfaction with treatment, utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost-effectiveness, resource use, and cost.
We will follow patients at 6 weeks and 3, 6, 12, and 24 months to determine their health status, function, satisfaction, and health care use. We anticipate that we will enroll and randomly allocate a total of 300 study participants in this arm of the trial. We will track an additional observational cohort to assess health and resource outcomes. Enrollment in the Observational cohort has been completed as of February 2003.
We will integrate data from the trial and observational cohorts to formally estimate the cost-effectiveness of surgical versus nonsurgical interventions for IDH, SpS, and DS. The results of this trial will provide, for the first time, scientific evidence as to the relative effectiveness of surgical versus nonsurgical treatment for these three most commonly diagnosed lumbar spine conditions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000409
|United States, California|
|Kaiser Permanente Spine Care Program|
|Oakland, California, United States, 94612|
|University of California, San Francisco (UCSF)|
|San Francisco, California, United States, 94143-0728|
|United States, Georgia|
|Emory University, The Emory Clinic|
|Decatur, Georgia, United States, 30033|
|United States, Illinois|
|Rush-Presbyterian, St. Luke's Medical Center|
|Chicago, Illinois, United States, 60612-3833|
|United States, Maine|
|Maine Spine & Rehabilitation|
|Scarborough, Maine, United States, 04074|
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073-9952|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|United States, Nebraska|
|Nebraska Foundation for Spinal Research|
|Omaha, Nebraska, United States, 68154-4438|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center - Spine Center|
|Lebanon, New Hampshire, United States, 03756|
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|New York University, The Hospital for Joint Diseases|
|New York, New York, United States, 10003|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|United States, Pennsylvania|
|Rothman Institute at Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107-4216|
|Principal Investigator:||James N. Weinstein, DO, MS||Dartmouth-Hitchcock Medical Center|