HINTEGRA Total Ankle Prosthesis Follow-up

Integra LifeSciences Services225 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

225

Conditions

Total Ankle Prosthesis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Medical University of Innsbruck

Innsbruck, Austria

St. Michael's Hospital

Toronto, Canada

CHU d'Amiens - Hopital Nord

Amiens, France

AukammKlinik

Wiesbaden, Germany

Outcomes

Primary Outcomes

rate of device related complications at the follow up after 2 years of implantation

Time frame: more than 2 years after the implantation

Secondary Outcomes

AOFAS Ankle-Hindfoot Scale score (American Orthopaedic Foot and Ankle Society).

Time frame: more than 2 years after the implantation

Data from ClinicalTrials.gov

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