HINTEGRA Total Ankle Prosthesis Follow-up

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01284972

Enrollment

225

Registered

2011-01-27

Start date

2009-02-28

Completion date

2010-12-31

Last updated

2012-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Ankle Prosthesis

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
rate of device related complications at the follow up after 2 years of implantation	more than 2 years after the implantation

Secondary

Measure	Time frame
AOFAS Ankle-Hindfoot Scale score (American Orthopaedic Foot and Ankle Society).	more than 2 years after the implantation

Countries

Austria, Canada, France, Germany, South Korea, Spain

Outcome results