Spine Patient Outcomes Research Trial (SPORT): Degenerative Spondylolisthesis With Spinal Stenosis (SPORT)
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| ClinicalTrials.gov Identifier: NCT00000409 |
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Recruitment Status :
Completed
First Posted : November 4, 1999
Last Update Posted : August 4, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spondylolisthesis Spinal Stenosis Low Back Pain | Procedure: Decompressive laminectomy Other: Non-surgical treatments Procedure: Fusion--Instrumented Procedure: Fusion-Non-instrumented | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 304 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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. |
| Study Start Date : | March 2000 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | April 2015 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Surgery
Decompressive Laminectomy Fusion-Instrumented Fusion-Non-instrumented
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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 stenosis 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. 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. |
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Active Comparator: Non-surgical intervention
Other. Non-surgical treatments
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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. |
- 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 ]
- Patient satisfaction with treatment [ Time Frame: Baseline, 6 wks, 3 mos, Annually thereafter ]
- 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 ]
- resource utilization [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ]
- cost [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Duration of Symptoms: 12 or more weeks.
- Treatments Tried: Nonsteroidal. anti-inflammatory medical therapy and physical therapy.
- Surgical Screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms.
- Tests: MRI to confirm diagnosis and level(s).
Exclusion Criteria:
- Previous lumbar spine surgery.
- Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months.
- Possible pregnancy.
- Active malignancy: Patients with a history of any invasive malignancy (except nonmelanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years.
- Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
- Age less than 18 years.
- Cauda equina syndrome or progressive neurologic deficit (usually requiring urgent surgery).
- Unavailability for followup (planning to move, no telephone, etc.) or inability to complete data surveys.
- Symptoms less than 12 weeks.
- Patient currently enrolled in any experimental "spine related" study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
| Washington University | |
| 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 | |
| New York University, The Hospital for Joint Diseases | |
| New York, New York, United States, 10003 | |
| Hospital for Special Surgery | |
| New York, New York, United States, 10021 | |
| 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 |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT00000409 |
| Other Study ID Numbers: |
U01 AR45444 NIAMS-004A U01AR045444 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 4, 1999 Key Record Dates |
| Last Update Posted: | August 4, 2015 |
| Last Verified: | August 2015 |
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Intervertebral disc herniation (IDH) Degenerative spondylolisthesis (DS) Spinal stenosis (SpS) Low back pain (LBP) Leg pain |
Surgical therapy Randomized study Multicenter MRI Nonsurgical therapy |
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Spinal Stenosis Spondylolisthesis Back Pain Low Back Pain Constriction, Pathologic Pain Neurologic Manifestations |
Pathological Conditions, Anatomical Spinal Diseases Bone Diseases Musculoskeletal Diseases Spondylolysis Spondylosis |