Completed

Phase 4
Age: 18Years +
All Genders
ID00000409

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

Led by Dartmouth-Hitchcock Medical Center · Updated on 2015-08-04

304

Participants Needed

13

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Dartmouth-Hitchcock Medical Center

Lead Sponsor

N

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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).
Not Eligible

You will not qualify if you...

  • 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.

Trial Site Locations

Total: 13 locations

1

Kaiser Permanente Spine Care Program

Oakland, California, United States, 94612

Status Unknown

2

University of California, San Francisco (UCSF)

San Francisco, California, United States, 94143-0728

Status Unknown

3

Emory University, The Emory Clinic

Decatur, Georgia, United States, 30033

Status Unknown

4

Rush-Presbyterian, St. Luke's Medical Center

Chicago, Illinois, United States, 60612-3833

Status Unknown

5

Maine Spine & Rehabilitation

Scarborough, Maine, United States, 04074

Status Unknown

6

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073-9952

Status Unknown

7

Washington University

St Louis, Missouri, United States, 63110

Status Unknown

8

Nebraska Foundation for Spinal Research

Omaha, Nebraska, United States, 68154-4438

Status Unknown

9

Dartmouth-Hitchcock Medical Center - Spine Center

Lebanon, New Hampshire, United States, 03756

Status Unknown

10

New York University, The Hospital for Joint Diseases

New York, New York, United States, 10003

Status Unknown

11

Hospital for Special Surgery

New York, New York, United States, 10021

Status Unknown

12

Case Western Reserve University

Cleveland, Ohio, United States, 44106

Status Unknown

13

Rothman Institute at Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107-4216

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Designing an ambulatory clinical practice for outcomes improvement: from vision to reality--the Spine Center at Dartmouth-Hitchcock, year one.

J N Weinstein, P W Brown, B Hanscom...

https://pubmed.ncbi.nlm.nih.gov/10787504

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.

Thomas L Walsh, Brett Hanscom, Jon D Lurie...

https://pubmed.ncbi.nlm.nih.gov/12642770

Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts.

James N Weinstein, Jon D Lurie, Tor D Tosteson...

https://pubmed.ncbi.nlm.nih.gov/19487505

Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation.

Anna N A Tosteson, Tor D Tosteson, Jon D Lurie...

https://pubmed.ncbi.nlm.nih.gov/22048651

Degenerative spondylolisthesis: does fusion method influence outcome? Four-year results of the spine patient outcomes research trial.

William A Abdu, Jon D Lurie, Kevin F Spratt...

https://pubmed.ncbi.nlm.nih.gov/19755935