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Royal Oak, Michigan 48073


Purpose:

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.


Study summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

U01 AR45444 NIAMS-004A


NCT ID:

NCT00000409


Secondary ID:

U01AR045444


Study Acronym:

SPORT


Brief Title:

Spine Patient Outcomes Research Trial (SPORT): Degenerative Spondylolisthesis With Spinal Stenosis


Official Title:

Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Degenerative Spondylolisthesis (DS) With Spinal Stenosis (SpS) at L4/L5 Level.


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dartmouth-Hitchcock Medical Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

304


Enrollment Type:

Actual


Overall Contact Information

Official Name:James N. Weinstein, DO, MS
Principal Investigator
Dartmouth-Hitchcock Medical Center

Study Dates

Start Date:March 2000
Completion Date:April 2015
Completion Type:Actual
Primary Completion Date:April 2015
Primary Completion Type:Actual
Verification Date:August 2015
Last Changed Date:August 3, 2015
First Received Date:November 3, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient satisfaction with treatment
Time Frame:Baseline, 6 wks, 3 mos, Annually thereafter
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:resource utilization
Time Frame:Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:cost
Time Frame:Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Decompressive laminectomy
Description: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
Arm Name:Surgery
Intervention Type:Other
Name:Non-surgical treatments
Description: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.
Arm Name:Surgery
Intervention Type:Procedure
Name:Fusion--Instrumented
Description: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.
Arm Name:Surgery
Intervention Type:Procedure
Name:Fusion-Non-instrumented
Description: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.
Arm Name:Surgery

Study Arms

Study Arm Type:Active Comparator
Arm Name:Surgery
Description:Decompressive Laminectomy Fusion-Instrumented Fusion-Non-instrumented
Study Arm Type:Active Comparator
Arm Name:Non-surgical intervention
Description:Other. Non-surgical treatments

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dartmouth-Hitchcock Medical Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:22048651
Reference Type:Results Reference
Citation: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.
PMID:19487505
Reference Type:Results Reference
Citation: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.
PMID:17538085
Reference Type:Reference
Citation: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.
PMID:12642770
Reference Type:Reference
Citation: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.
PMID:12642771
Reference Type:Reference
Citation: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.
PMID:14520044
Reference Type:Reference
Citation: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. Review.
PMID:10787504
Reference Type:Reference
Citation: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.
PMID:12065987

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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