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Greenwich Lumbar Stenosis SLIP Study

NCT ID: NCT00109213

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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There is considerable debate among spinal surgeons regarding the optimal surgical procedure for lumbar spinal stenosis with a grade I spondylolisthesis. The major question is whether or not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy is performed to relieve neural compression. This multi-center, randomized, prospective clinical study aims to address this question by testing the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long-term patient outcomes.

Conditions

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Spinal Stenosis Spondylolisthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Lumbar Laminectomy without Fusion

Group Type ACTIVE_COMPARATOR

Lumbar Laminectomy

Intervention Type PROCEDURE

Removal of bone to decompress spinal nerves

2

Lumbar Laminectomy with Pedicle Screw Instrumented Fusion

Group Type ACTIVE_COMPARATOR

Lumbar Laminectomy with Instrumented Pedicle Screw Fusion

Intervention Type PROCEDURE

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

Interventions

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Lumbar Laminectomy with Instrumented Pedicle Screw Fusion

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

Intervention Type PROCEDURE

Lumbar Laminectomy

Removal of bone to decompress spinal nerves

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Greenwich Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zoher Ghogawala, MD

Role: STUDY_DIRECTOR

Yale University School of Medicine (Greenwich Hospital)

Edward C Benzel, MD

Role: STUDY_DIRECTOR

Cleveland Clinic Spine Institute (Cleveland Clinic Foundation)

Locations

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Greenwich Hospital

Greenwich, Connecticut, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Lahey Clinic

Burlington, Massachusetts, United States

Site Status

Cleveland Clinic Spine Institute

Cleveland, Ohio, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15478364 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9431616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2071615 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27074067 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26501698 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23373567 (View on PubMed)

Other Identifiers

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GH-SLIP-384

Identifier Type: -

Identifier Source: org_study_id