Trials / Not Yet Recruiting
Not Yet RecruitingNCT06106061
Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- Sponsor
- SC Medica · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant. The main objective is to evaluate the effectiveness of spinal decompression associated with FFX® implants compared to spinal decompression alone in treating lumbar spinal stenosis after 2 years of treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Decompression + FFX® | Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression associated with the use of FFX® implant |
| PROCEDURE | Decompression alone | Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression alone |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2023-10-30
- Last updated
- 2023-10-30
Source: ClinicalTrials.gov record NCT06106061. Inclusion in this directory is not an endorsement.