Trials / Recruiting
RecruitingNCT02555280
Coflex PS3 Actual Conditions for Use Study
A 2 and 5 Year Evaluation of Clinical Outcomes in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With Additional Stabilization Using the Coflex® Interlaminar Technology for FDA Actual Conditions for Use Study.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Xtant Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.
Detailed description
A prospective, multi center, concurrently enrolled, propensity score controlled through Month 60. The purpose is to fully characterize safety and efficacy then the coflex device is used in the intended subject population under actual conditions of use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | coflex® Interlaminar Technology | Decompression plus coflex® Interlaminar Technology |
| PROCEDURE | Decompression | Decompression alone |
Timeline
- Start date
- 2019-09-09
- Primary completion
- 2024-09-01
- Completion
- 2027-11-01
- First posted
- 2015-09-21
- Last updated
- 2024-01-05
Locations
19 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02555280. Inclusion in this directory is not an endorsement.