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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00000409
First received: November 3, 1999
Last updated: August 18, 2014
Last verified: August 2014
  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.


Condition Intervention Phase
Spondylolisthesis
Spinal Stenosis
Low Back Pain
Procedure: Decompressive laminectomy
Other: Non-surgical treatments
Procedure: Fusion--Instrumented
Procedure: Fusion-Non-instrumented
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction with treatment [ Time Frame: Baseline, 6 wks, 3 mos, Annually thereafter ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • resource utilization [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ] [ Designated as safety issue: No ]
  • cost [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ] [ Designated as safety issue: No ]

Enrollment: 304
Study Start Date: March 2000
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgery
Decompressive Laminectomy Fusion-Instrumented Fusion-Non-instrumented
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.
Active Comparator: Non-surgical intervention
Other. Non-surgical treatments
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000409

Locations
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
Hospital for Special Surgery
New York, New York, United States, 10021
New York University, The Hospital for Joint Diseases
New York, New York, United States, 10003
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
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: James N. Weinstein, DO, MS Dartmouth-Hitchcock Medical Center
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00000409     History of Changes
Other Study ID Numbers: U01 AR45444 NIAMS-004A, U01AR045444
Study First Received: November 3, 1999
Last Updated: August 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Dartmouth-Hitchcock Medical Center:
Intervertebral disc herniation (IDH)
Degenerative spondylolisthesis (DS)
Spinal stenosis (SpS)
Low back pain (LBP)
Leg pain
Surgical therapy
Randomized study
Multicenter
MRI
Nonsurgical therapy

Additional relevant MeSH terms:
Back Pain
Constriction, Pathologic
Low Back Pain
Spinal Stenosis
Spondylolisthesis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on August 28, 2014