CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 66 enrolled
Drug / intervention
Lumbar Laminectomy with Instrumented Pedicle Screw Fusion +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00109213
NCT00109213Phase 3Completed

Greenwich Lumbar Stenosis SLIP Study: A Multi-center, Randomized, Prospective Clinical Trial Comparing Spinal Laminectomy to Laminectomy With Instrumented Pedicle Screw Fusion for Lumbar Stenosis With Grade I Spondylolisthesis

Greenwich Hospital·interventional·Posted Apr 26, 2005·Updated Dec 3, 2015

In Brief

A Phase 3 clinical trial evaluating Lumbar Laminectomy with Instrumented Pedicle Screw Fusion and Lumbar Laminectomy for Spinal Stenosis and Spondylolisthesis. Completed, enrolled 66 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 26, 2005
Enrollment StartMay 1, 2002
Primary CompletionSep 1, 2009
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 21.2 years ago

Interventions

Lumbar Laminectomy with Instrumented Pedicle Screw Fusionprocedure

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

Lumbar Laminectomyprocedure

Removal of bone to decompress spinal nerves