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OpenTrials
Completed

NCT Number: NCT01284972

HINTEGRA Total Ankle Prosthesis Follow-up

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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Key information

Conditions

Total Ankle Prosthesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Innsbruck, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

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

    Time frame: more than 2 years after the implantation

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Services

Industry

Registry information

Official study title

Short to Mid Term Follow-up of Patient Implanted With the HINTEGRA® Total Ankle Prosthesis

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 27, 2011
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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