Spine Patient Outcomes Research Trial (SPORT): Degenerative Spondylolisthesis With Spinal Stenosis
NCT ID: NCT00000409
Last Updated: 2015-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
304 participants
INTERVENTIONAL
2000-03-31
2015-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgery
Decompressive Laminectomy Fusion-Instrumented Fusion-Non-instrumented
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
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.
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.
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.
Non-surgical intervention
Other. Non-surgical treatments
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.
Interventions
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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
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
National Institute for Occupational Safety and Health (NIOSH/CDC)
FED
Office of Research on Women's Health (ORWH)
NIH
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Principal Investigators
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James N. Weinstein, DO, MS
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Kaiser Permanente Spine Care Program
Oakland, California, United States
University of California, San Francisco (UCSF)
San Francisco, California, United States
Emory University, The Emory Clinic
Decatur, Georgia, United States
Rush-Presbyterian, St. Luke's Medical Center
Chicago, Illinois, United States
Maine Spine & Rehabilitation
Scarborough, Maine, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Washington University
St Louis, Missouri, United States
Nebraska Foundation for Spinal Research
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center - Spine Center
Lebanon, New Hampshire, United States
New York University, The Hospital for Joint Diseases
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
Case Western Reserve University
Cleveland, Ohio, United States
Rothman Institute at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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References
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Birkmeyer NJ, Weinstein JN, Tosteson AN, Tosteson TD, Skinner JS, Lurie JD, Deyo R, Wennberg JE. Design of the Spine Patient outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2002 Jun 15;27(12):1361-72. doi: 10.1097/00007632-200206150-00020.
Weinstein JN, Brown PW, Hanscom B, Walsh T, Nelson EC. Designing an ambulatory clinical practice for outcomes improvement: from vision to reality--the Spine Center at Dartmouth-Hitchcock, year one. Qual Manag Health Care. 2000 Winter;8(2):1-20. doi: 10.1097/00019514-200008020-00003.
Fanciullo GJ, Hanscom B, Weinstein JN, Chawarski MC, Jamison RN, Baird JC. Cluster analysis classification of SF-36 profiles for patients with spinal pain. Spine (Phila Pa 1976). 2003 Oct 1;28(19):2276-82. doi: 10.1097/01.BRS.0000084880.33281.EB.
Lurie JD, Birkmeyer NJ, Weinstein JN. Rates of advanced spinal imaging and spine surgery. Spine (Phila Pa 1976). 2003 Mar 15;28(6):616-20. doi: 10.1097/01.BRS.0000049927.37696.DC.
Walsh TL, Hanscom B, Lurie JD, Weinstein JN. Is a condition-specific instrument for patients with low back pain/leg symptoms really necessary? The responsiveness of the Oswestry Disability Index, MODEMS, and the SF-36. Spine (Phila Pa 1976). 2003 Mar 15;28(6):607-15. doi: 10.1097/01.BRS.0000050654.97387.DF.
Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.
Weinstein JN, Lurie JD, Tosteson TD, Zhao W, Blood EA, Tosteson AN, Birkmeyer N, Herkowitz H, Longley M, Lenke L, Emery S, Hu SS. Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. J Bone Joint Surg Am. 2009 Jun;91(6):1295-304. doi: 10.2106/JBJS.H.00913.
Tosteson AN, Tosteson TD, Lurie JD, Abdu W, Herkowitz H, Andersson G, Albert T, Bridwell K, Zhao W, Grove MR, Weinstein MC, Weinstein JN. Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2061-8. doi: 10.1097/BRS.0b013e318235457b.
Abdu WA, Lurie JD, Spratt KF, Tosteson AN, Zhao W, Tosteson TD, Herkowitz H, Longely M, Boden SD, Emery S, Weinstein JN. Degenerative spondylolisthesis: does fusion method influence outcome? Four-year results of the spine patient outcomes research trial. Spine (Phila Pa 1976). 2009 Oct 1;34(21):2351-60. doi: 10.1097/BRS.0b013e3181b8a829.
Other Identifiers
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U01 AR45444 NIAMS-004A
Identifier Type: -
Identifier Source: org_study_id
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