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NCT00109213 · ClinicalTrials.gov registry record · Phase 3

Greenwich Lumbar Stenosis SLIP Study

A Phase 3 study of Spondylolisthesis and Spinal Stenosis, sponsored by Greenwich Hospital.

Completed
Registry status
Phase 3
Development phase
66
Enrollment target
5
Study locations

NCT00109213 is a Phase 3 study of Spondylolisthesis and Spinal Stenosis that has completed, run by Greenwich Hospital. The registered enrollment target is 66 participants, below the 149-participant average among 18 other Spondylolisthesis trials with a reported enrollment target (56% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT00109213, a Phase 3 study of Spondylolisthesis and Spinal Stenosis, has completed, sponsored by Greenwich Hospital.

COMPLETED
Registry status
Phase 3
Development phase
66 participants
Enrollment target
5
Study locations

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.

Interventions

  • PROCEDURE Lumbar Laminectomy with Instrumented Pedicle Screw Fusion
  • PROCEDURE Lumbar Laminectomy

Study Locations (5)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Lahey Clinic - Burlington

Connecticut

  • Greenwich Hospital - Greenwich

Ohio

  • Cleveland Clinic Spine Institute - Cleveland

Rhode Island

  • Rhode Island Hospital - Providence

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2002-05
Est. Completion 2014-10
Phase Phase 3

Sponsor

Greenwich Hospital

3 total trials

What the Registry Record Tells You About NCT00109213

The ClinicalTrials.gov registry entry for NCT00109213 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 149-participant average among 18 other Spondylolisthesis trials with a reported enrollment target (56% lower). The listed sponsor is Greenwich Hospital, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Spondylolisthesis appearing as the primary indexed condition, and to 2 interventions - of which Lumbar Laminectomy with Instrumented Pedicle Screw Fusion is the first listed.

NCT00109213 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Massachusetts, Connecticut, Ohio.

Frequently Asked Questions

What is clinical trial NCT00109213 about?

NCT00109213 is a clinical study titled "Greenwich Lumbar Stenosis SLIP Study". 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 ar...

What is the current status of trial NCT00109213?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 2002-05. Estimated completion is 2014-10.

What conditions does trial NCT00109213 study?

This clinical trial studies the following conditions: Spondylolisthesis, Spinal Stenosis.

What interventions are being tested in trial NCT00109213?

The interventions under investigation include: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion (PROCEDURE), Lumbar Laminectomy (PROCEDURE).

Who is sponsoring clinical trial NCT00109213?

This trial is sponsored by Greenwich Hospital, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00109213 being conducted?

This trial has 5 study locations across Connecticut, Massachusetts, Ohio, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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