Trials / Completed
CompletedNCT03761563
Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease
Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease (FORTE)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (actual)
- Sponsor
- Xtant Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology.
Detailed description
This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology. There will be 3 arms in the study, one for each configuration of the Fortilink IBF system (Fortilink-C, Fortilink-TS and Fortilink-L). Up to 50 subjects will be enrolled in each study arm for a total of up to 150 subjects at up to 20 sites in the United States (US) and European Union (EU).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Fortilink IBF System with TETRAfuse Technology | Cervical and lumbar fusion |
Timeline
- Start date
- 2019-02-13
- Primary completion
- 2023-06-30
- Completion
- 2023-12-30
- First posted
- 2018-12-03
- Last updated
- 2024-03-15
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03761563. Inclusion in this directory is not an endorsement.