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

Low Back Pain Clinical Trial

— SPORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000409
• Other study ID #: U01 AR45444 NIAMS-004A
• Secondary ID: U01AR045444
• Status: Completed
• Phase: Phase 4
• First received: November 3, 1999
• Last updated: August 3, 2015
• Start date: March 2000
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Low Back Pain
• Spinal Stenosis
• Spondylolisthesis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rush-Presbyterian, St. Luke's Medical Center	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Emory University, The Emory Clinic	Decatur	Georgia
United States	Dartmouth-Hitchcock Medical Center - Spine Center	Lebanon	New Hampshire
United States	Hospital for Special Surgery	New York	New York
United States	New York University, The Hospital for Joint Diseases	New York	New York
United States	Kaiser Permanente Spine Care Program	Oakland	California
United States	Nebraska Foundation for Spinal Research	Omaha	Nebraska
United States	Rothman Institute at Thomas Jefferson University	Philadelphia	Pennsylvania
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University of California, San Francisco (UCSF)	San Francisco	California
United States	Maine Spine & Rehabilitation	Scarborough	Maine
United States	Washington University	St. Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute for Occupational Safety and Health (NIOSH/CDC), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Research on Women's Health (ORWH)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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 — View 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. — View 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. — View 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 — View 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 Patie — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in health-related quality of life as measured by the SF-36 health status questionnaire		Baseline, 6 wks, 3 and 6 mos, Annually thereafter	No
Secondary	Patient satisfaction with treatment		Baseline, 6 wks, 3 mos, Annually thereafter	No
Secondary	utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness		Baseline, 1 yr, 4 yr	No
Secondary	resource utilization		Baseline, 6 wks, 3 and 6 mos, Annually thereafter	No
Secondary	cost		Baseline, 6 wks, 3 and 6 mos, Annually thereafter	No

External Links

•   Click here to view the Spine Patient Outcomes Research Trial (SPORT) Web site.