HINTEGRA Total Ankle Prosthesis Follow-up

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

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.

Study Overview

• Status: Completed
• Conditions: Total Ankle Prosthesis

• Study Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, A-6020
    • Medical University of Innsbruck
• Canada
  • Toronto, Canada, M5C 1R6
    • St. Michael's Hospital
• France
  • Amiens, France, 80054
    • CHU d'Amiens - Hôpital Nord
• Germany
  • Wiesbaden, Germany, 65191
    • AukammKlinik
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital - Yonsei University
• Spain
  • Barcelona, Spain, 08035
    • Hopital San Rafael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient implanted with an Hintegra® Total Ankle Prosthesis (only prosthesis designed with pegs) in primary ankle surgery since a minimum of 2 years

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HINTEGRA; Patient Implanted with the HINTEGRA Total Ankle Prosthesis more than 2 years ago

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Integra LifeSciences Services

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 26, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): October 10, 2012
• Last Update Submitted That Met QC Criteria: October 9, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: RECON-EMEA-02