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

PHASE4CompletedINTERVENTIONAL
Enrollment

304

Participants

Timeline

Start Date

March 31, 2000

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
SpondylolisthesisSpinal StenosisLow Back Pain
Interventions
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.

Trial Locations (13)

10003

New York University, The Hospital for Joint Diseases, New York

10021

Hospital for Special Surgery, New York

30033

Emory University, The Emory Clinic, Decatur

44106

Case Western Reserve University, Cleveland

63110

Washington University, St Louis

94612

Kaiser Permanente Spine Care Program, Oakland

94143-0728

University of California, San Francisco (UCSF), San Francisco

60612-3833

Rush-Presbyterian, St. Luke's Medical Center, Chicago

04074

Maine Spine & Rehabilitation, Scarborough

48073-9952

William Beaumont Hospital, Royal Oak

68154-4438

Nebraska Foundation for Spinal Research, Omaha

03756

Dartmouth-Hitchcock Medical Center - Spine Center, Lebanon

19107-4216

Rothman Institute at Thomas Jefferson University, Philadelphia

All Listed Sponsors
collaborator

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

NIH

collaborator

National Institute for Occupational Safety and Health (NIOSH/CDC)

FED

collaborator

Office of Research on Women's Health (ORWH)

NIH

lead

Dartmouth-Hitchcock Medical Center

OTHER

NCT00000409 - Spine Patient Outcomes Research Trial (SPORT): Degenerative Spondylolisthesis With Spinal Stenosis | Biotech Hunter | Biotech Hunter