HINTEGRA Total Ankle Prosthesis Follow-up

Integra LifeSciences

Status: Completed

Conditions: Total Ankle Prosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT01284972

RECON-EMEA-02

Details and patient eligibility

About

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.

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

225 participants in 1 patient group

HINTEGRA

Description:

Patient Implanted with the HINTEGRA Total Ankle Prosthesis more than 2 years ago