HINTEGRA Total Ankle Prosthesis Follow-up

Completed

• Conditions: Total Ankle Prosthesis

• Registration Number: NCT01284972
• Lead Sponsor: Integra LifeSciences Services

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-09
• Last Update Posted: 2012-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• Patient implanted with an Hintegra® Total Ankle Prosthesis (only prosthesis designed with pegs) in primary ankle surgery since a minimum of 2 years
• Age ≥ 18 years
• Have willingness to give his/her data transfer authorisation

Exclusion Criteria

• History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of device related complications at the follow up after 2 years of implantation	more than 2 years after the implantation

Secondary Outcome Measures

Name	Time	Method
AOFAS Ankle-Hindfoot Scale score (American Orthopaedic Foot and Ankle Society).	more than 2 years after the implantation

Trial Locations

Locations (6)

AukammKlinik; 🇩🇪 Wiesbaden, Germany

Medical University of Innsbruck; 🇦🇹 Innsbruck, Austria

CHU d'Amiens - Hopital Nord; 🇫🇷 Amiens, France

Hopital San Rafael; 🇪🇸 Barcelona, Spain

St. Michael's Hospital; 🇨🇦 Toronto, Canada

Severance Hospital - Yonsei University; 🇰🇷 Seoul, Korea, Republic of