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Greenwich Lumbar Stenosis SLIP Study

NCT00109213 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2015-12-03

No results posted yet for this study

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

Interventions

PROCEDURE

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

PROCEDURE

Lumbar Laminectomy

Removal of bone to decompress spinal nerves

Sponsors & Collaborators

  • Greenwich Hospital

    lead OTHER

Principal Investigators

  • Zoher Ghogawala, MD · Yale University School of Medicine (Greenwich Hospital)

  • Edward C Benzel, MD · Cleveland Clinic Spine Institute (Cleveland Clinic Foundation)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2009-09-30
Completion
2014-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00109213 on ClinicalTrials.gov