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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: Completed Phase 3 study of Spondylolisthesis and Spinal Stenosis, sponsored by Greenwich Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2002-05 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT00109213 record still lists
NCT00109213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 149-participant average among 18 other Spondylolisthesis trials with a reported enrollment target (56% lower).
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 lists 5 locations in 4 states (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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66 11th of 18 higher than 8 of 18 other Spondylolisthesis trials
participants (enrollment target), bucketed by value
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