Trials / Completed
CompletedNCT03699891
Evaluation of the Fortilink IBF System With TETRAfuse Technology
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 119 (actual)
- Sponsor
- RTI Surgical · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System.
Detailed description
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System. The study will include up to 110 patients at up to 8 US sites. All patients implanted with the Fortilink System at a site will be included in the data collection. The goal is to collect data for at least 100 subjects, but the sample size will be capped at 110 to ensure that all patients at a given site are included in the analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Fortilink IBF System with TETRAfuse Technology | Cervical and lumbar fusion |
Timeline
- Start date
- 2018-11-06
- Primary completion
- 2019-01-15
- Completion
- 2019-01-15
- First posted
- 2018-10-09
- Last updated
- 2019-10-02
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03699891. Inclusion in this directory is not an endorsement.