Greenwich Lumbar Stenosis SLIP Study

NCT00109213 | Completed Phase 3 DMC

• 1 other identifier: GH-SLIP-384
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). There are two types of operations that surgeons perform for this problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.

Conditions

Spinal Stenosis; Spondylolisthesis

Keywords

Spinal Stenosis; Lumbar Spine; Decompression; Fusion; Spondylolisthesis; Prospective, randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• SF-36 (physical component summary score)

  2 year

Secondary Outcomes (2)

• Oswestry Disability Index

  2 year, 3 year, 4 year

• Major Complication rate

  30 days

Study Arms (2)

1

ACTIVE COMPARATOR

Lumbar Laminectomy without Fusion

Procedure: Lumbar Laminectomy

2

ACTIVE COMPARATOR

Lumbar Laminectomy with Pedicle Screw Instrumented Fusion

Procedure: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion

Interventions

Lumbar Laminectomy with Instrumented Pedicle Screw Fusion PROCEDURE

Removal of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine

2

Lumbar Laminectomy PROCEDURE

Removal of bone to decompress spinal nerves

1

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic lumbar spinal stenosis and single level grade I spondylolisthesis (3-14 mm)

You may not qualify if:

• History of previous lumbar spinal surgery in region of stenosis
• Gross spinal instability (defined as greater than 3 mm motion on flexion/extension studies)
• Serious medical illness (ASA Class III or higher)
• Spondylolisthesis greater than 14 mm or associated with spondylolysis

Sponsors & Collaborators

• Greenwich Hospital: lead

Study Sites (5)

Greenwich Hospital

Greenwich, Connecticut, 06830, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Cleveland Clinic Spine Institute

Cleveland, Ohio, 44195, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (6)

• Ghogawala Z, Benzel EC, Amin-Hanjani S, Barker FG 2nd, Harrington JF, Magge SN, Strugar J, Coumans JV, Borges LF. Prospective outcomes evaluation after decompression with or without instrumented fusion for lumbar stenosis and degenerative Grade I spondylolisthesis. J Neurosurg Spine. 2004 Oct;1(3):267-72. doi: 10.3171/spi.2004.1.3.0267.

  PMID: 15478364 BACKGROUND

• Fischgrund JS, Mackay M, Herkowitz HN, Brower R, Montgomery DM, Kurz LT. 1997 Volvo Award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2807-12. doi: 10.1097/00007632-199712150-00003.

  PMID: 9431616 BACKGROUND

• Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.

  PMID: 2071615 BACKGROUND

• Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.

  PMID: 27074067 DERIVED

• Ghogawala Z, Schwartz JS, Benzel EC, Magge SN, Coumans JV, Harrington JF, Gelbs JC, Whitmore RG, Butler WE, Barker FG 2nd. Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel. Ann Surg. 2016 Jul;264(1):81-6. doi: 10.1097/SLA.0000000000001483.

  PMID: 26501698 DERIVED

• Blumenthal C, Curran J, Benzel EC, Potter R, Magge SN, Harrington JF Jr, Coumans JV, Ghogawala Z. Radiographic predictors of delayed instability following decompression without fusion for degenerative grade I lumbar spondylolisthesis. J Neurosurg Spine. 2013 Apr;18(4):340-6. doi: 10.3171/2013.1.SPINE12537. Epub 2013 Feb 1.

  PMID: 23373567 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Zoher Ghogawala, MD

  Yale University School of Medicine (Greenwich Hospital)

  STUDY DIRECTOR

• Edward C Benzel, MD

  Cleveland Clinic Spine Institute (Cleveland Clinic Foundation)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2005
• First Posted: April 26, 2005
• Study Start: May 1, 2002
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2014
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (5)