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HINTEGRA Total Ankle Prosthesis Follow-up

NCT ID: NCT01284972

Last Updated: 2012-10-10

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.

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Integra LifeSciences Services

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of Innsbruck

Innsbruck, , Austria

Site Status

St. Michael's Hospital

Toronto, , Canada

Site Status

CHU d'Amiens - Hopital Nord

Amiens, , France

Site Status

AukammKlinik

Wiesbaden, , Germany

Site Status

Severance Hospital - Yonsei University

Seoul, , South Korea

Site Status

Hopital San Rafael

Barcelona, , Spain

Site Status

Countries

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Austria Canada France Germany South Korea Spain

Other Identifiers

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RECON-EMEA-02

Identifier Type: -

Identifier Source: org_study_id