At a glance
ClinicalIndex Comparison RecordN/ACompleted· 246 enrolled
Drug / intervention
Implantation of coflex™ after surgical decompression +1 moredevice
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.
Comparative Evaluation of Clinical Outcome in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With and Without Additional Stabilization Using the Coflex™ Interlaminar Technology
In Brief
A clinical study evaluating Implantation of coflex™ after surgical decompression and Surgical decompression for Spinal Stenosis. Completed, enrolled 246 participants across 8 sites.
Detailed Summary
A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar Technology
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Stenosis
CountriesGermany
CollaboratorsMDT Medical Device Testing GmbH, MCRA
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedMar 2011
Primary CompletionAug 2014
TodayJul 2026
First PostedMar 16, 2011
Enrollment StartJan 1, 2008
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 15.3 years ago
Interventions
Implantation of coflex™ after surgical decompressiondevice
The device will be implanted after surgical decompression in patients with spinal stenosis.
Surgical decompressionprocedure
Surgical decompression in patients with spinal stenosis without stabilization by an additional implant