Clinical trial NCT00000409: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spondylolisthesis
Spinal Stenosis
Low Back Pain
Keywords: Intervertebral disc herniation (IDH)
Degenerative spondylolisthesis (DS)
Spinal stenosis (SpS)
Low back pain (LBP)
Leg pain
Surgical therapy
Randomized study
Multicenter
MRI
Nonsurgical therapy
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Institute for Occupational Safety and Health (NIOSH/CDC)
name: Office of Research on Women's Health (ORWH)
First posted: 1999-11-04
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Changes in health-related quality of life as measured by the SF-36 health status questionnaire
timeFrame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Secondary outcomes:
measure: Patient satisfaction with treatment
timeFrame: Baseline, 6 wks, 3 mos, Annually thereafter
measure: utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness
timeFrame: Baseline, 1 yr, 4 yr
measure: resource utilization
timeFrame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
measure: cost
timeFrame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Spine Care Program
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
city: Decatur
country: United States
facility: Emory University, The Emory Clinic
state: Georgia
city: Chicago
country: United States
facility: Rush-Presbyterian, St. Luke's Medical Center
state: Illinois
city: Scarborough
country: United States
facility: Maine Spine & Rehabilitation
state: Maine
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: Nebraska Foundation for Spinal Research
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center - Spine Center
state: New Hampshire
city: New York
country: United States
facility: New York University, The Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Philadelphia
country: United States
facility: Rothman Institute at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: James N. Weinstein, DO, MS
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/00007632-200206150-00020.
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. doi: 10.1097/00019514-200008020-00003.
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. doi: 10.1097/01.BRS.0000084880.33281.EB.
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. doi: 10.1097/01.BRS.0000049927.37696.DC.
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. doi: 10.1097/01.BRS.0000050654.97387.DF.
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. doi: 10.1056/NEJMoa070302.
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.
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.
citation: 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.