At a glance
ClinicalIndex Comparison RecordN/ACompleted· 322 enrolled
Drug / intervention
Decompression +2 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.
Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients
In Brief
A clinical study evaluating Decompression, Posterolateral Fusion and Implantation of Pedicle Screws, and 1 other intervention for Spinal Stenosis. Completed, enrolled 322 participants.
Detailed Summary
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Stenosis
Countries--
CollaboratorsMCRA
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2007
Enrollment StartOct 2012
Primary CompletionDec 2015
TodayJul 2026
First PostedSep 24, 2007
Enrollment StartOct 1, 2012
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.8 years ago
Interventions
Decompressionprocedure
Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain
Posterolateral Fusion and Implantation of Pedicle Screwsdevice
Implantation of coflex Interlaminar Technologydevice