Trials / Active Not Recruiting
Active Not RecruitingNCT04944576
Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®
Observational Multicenter Prospective Clinical Study on the Total Ankle Prosthesis, EasyMove®, Evaluating Safety and Performance up to 5 Years of Follow-up
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 82 (actual)
- Sponsor
- FH ORTHO · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a post-market clinical follow-up conducted in order to collect long-term data on safety and performance of the EasyMove prosthesis, which is intended to be implanted in case of total ankle replacement, when used in real life conditions according to the instructions for use.
Detailed description
The primary objective is to evaluate the safety of the total ankle prosthesis, EasyMove, up to five years of follow-up. The secondary objectives are to evaluate both the safety and the performance of the total ankle prosthesis, EasyMove, up to five years of follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Total Ankle Prosthesis, EasyMove® | Patients who will be implanted with a total ankle prosthesis, EasyMove. |
Timeline
- Start date
- 2021-09-14
- Primary completion
- 2029-09-13
- Completion
- 2029-09-13
- First posted
- 2021-06-29
- Last updated
- 2024-05-31
Locations
6 sites across 2 countries: France, Switzerland
Source: ClinicalTrials.gov record NCT04944576. Inclusion in this directory is not an endorsement.