HINTEGRA Total Ankle Prosthesis Follow-up

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services
ClinicalTrials.gov Identifier:
NCT01284972
First received: January 26, 2011
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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.


Condition
Total Ankle Prosthesis

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Short to Mid Term Follow-up of Patient Implanted With the HINTEGRA® Total Ankle Prosthesis

Further study details as provided by Integra LifeSciences Services:

Primary Outcome Measures:
  • rate of device related complications at the follow up after 2 years of implantation [ Time Frame: more than 2 years after the implantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • AOFAS Ankle-Hindfoot Scale score (American Orthopaedic Foot and Ankle Society). [ Time Frame: more than 2 years after the implantation ] [ Designated as safety issue: No ]

Enrollment: 225
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
HINTEGRA
Patient Implanted with the HINTEGRA Total Ankle Prosthesis more than 2 years ago

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284972

Locations
Austria
Medical University of Innsbruck
Innsbruck, Austria, A-6020
Canada
St. Michael's Hospital
Toronto, Canada, M5C 1R6
France
CHU d'Amiens - Hopital Nord
Amiens, France, 80054
Germany
AukammKlinik
Wiesbaden, Germany, 65191
Korea, Republic of
Severance Hospital - Yonsei University
Seoul, Korea, Republic of
Spain
Hopital San Rafael
Barcelona, Spain, 08035
Sponsors and Collaborators
Integra LifeSciences Services
  More Information

No publications provided

Responsible Party: Integra LifeSciences Services
ClinicalTrials.gov Identifier: NCT01284972     History of Changes
Other Study ID Numbers: RECON-EMEA-02
Study First Received: January 26, 2011
Last Updated: October 9, 2012
Health Authority: Canada: Ethics Review Committee
Austria: Ethikkommission
Germany: Ethics Commission
Spain: Comité Ético de Investigación Clínica
France: Institutional Ethical Committee

ClinicalTrials.gov processed this record on October 23, 2014