Trials / Completed
CompletedNCT01284972
HINTEGRA Total Ankle Prosthesis Follow-up
Short to Mid Term Follow-up of Patient Implanted With the HINTEGRA® Total Ankle Prosthesis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 225 (actual)
- Sponsor
- Integra LifeSciences Services · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The Hintegra® Total Ankle Prosthesis is a non constrained, three-component prosthesis that consists of a flat tibial component, an anatomically-shaped talar component, and a high-density polyethylene inlay. The Hintegra ankle was specifically developed as an attempt to address the needs of minimal bone resection, extended bone support, proper ligament balancing, and minimal contact stressed within and around the prosthesis. The objective of this study is to evaluate the safety and efficacy of the HINTEGRA® Total Ankle prosthesis at short and mid term follow up.
Conditions
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2011-01-27
- Last updated
- 2012-10-10
Locations
6 sites across 6 countries: Austria, Canada, France, Germany, South Korea, Spain
Source: ClinicalTrials.gov record NCT01284972. Inclusion in this directory is not an endorsement.