Trials / Completed
CompletedNCT01316211
Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 246 (actual)
- Sponsor
- Paradigm Spine · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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
Detailed description
The coflex® implant for interlaminar stabilization has been in clinical use for more than 10 years and is CE-certified according to the standards and approved in the United States. This was a randomized multicenter study to collect prospective data for potential improvement in the therapy of low back pain during the treatment of spinal stenosis. The study was conducted in Germany.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantation of coflex™ after surgical decompression | The device will be implanted after surgical decompression in patients with spinal stenosis. |
| PROCEDURE | Surgical decompression | Surgical decompression in patients with spinal stenosis without stabilization by an additional implant |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2014-08-01
- Completion
- 2014-08-01
- First posted
- 2011-03-16
- Last updated
- 2020-06-09
- Results posted
- 2020-06-02
Locations
8 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01316211. Inclusion in this directory is not an endorsement.