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

NCT00000409 | Completed Phase 4 DMC

• 2 other identifiers: U01 AR45444 NIAMS-004AU01AR045444
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Patient satisfaction with treatment

  Baseline, 6 wks, 3 mos, Annually thereafter

• utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness

  Baseline, 1 yr, 4 yr

• resource utilization

  Baseline, 6 wks, 3 and 6 mos, Annually thereafter

• cost

  Baseline, 6 wks, 3 and 6 mos, Annually thereafter

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Decompressive Laminectomy Fusion-Instrumented Fusion-Non-instrumented

Procedure: Decompressive laminectomy; Other: Non-surgical treatments; Procedure: Fusion--Instrumented; Procedure: Fusion-Non-instrumented

Non-surgical intervention

ACTIVE COMPARATOR

Other. Non-surgical treatments

Other: Non-surgical treatments

Interventions

Decompressive laminectomy PROCEDURE

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

Surgery

Non-surgical treatments OTHER

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.

Non-surgical intervention; Surgery

Fusion--Instrumented PROCEDURE

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.

Surgery

Fusion-Non-instrumented PROCEDURE

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.

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator
• Office of Research on Women's Health (ORWH): collaborator

Study Sites (13)

Kaiser Permanente Spine Care Program

Oakland, California, 94612, United States

Location

University of California, San Francisco (UCSF)

San Francisco, California, 94143-0728, United States

Location

Emory University, The Emory Clinic

Decatur, Georgia, 30033, United States

Location

Rush-Presbyterian, St. Luke's Medical Center

Chicago, Illinois, 60612-3833, United States

Location

Maine Spine & Rehabilitation

Scarborough, Maine, 04074, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073-9952, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Nebraska Foundation for Spinal Research

Omaha, Nebraska, 68154-4438, United States

Location

Dartmouth-Hitchcock Medical Center - Spine Center

Lebanon, New Hampshire, 03756, United States

Location

New York University, The Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Rothman Institute at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-4216, United States

Location

Related Publications (9)

• 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.

  PMID: 12065987 BACKGROUND

• 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.

  PMID: 10787504 BACKGROUND

• 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.

  PMID: 14520044 BACKGROUND

• 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.

  PMID: 12642771 BACKGROUND

• 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.

  PMID: 12642770 BACKGROUND

• 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.

  PMID: 17538085 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 19755935 DERIVED

MeSH Terms

Conditions

Spondylolisthesis; Spinal Stenosis; Low Back Pain; Intervertebral Disc Displacement

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• James N. Weinstein, DO, MS

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: March 1, 2000
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

US (13)