HINTEGRA Total Ankle Prosthesis Follow-up

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Ankle Prosthesis

Study Design

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Observational Model Type

CASE_ONLY

Study Groups

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HINTEGRA

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

No interventions assigned to this group

Eligibility Criteria

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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