ClinicalTrials.gov
ClinicalTrials.gov Menu

HINTEGRA Total Ankle Prosthesis Follow-up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01284972
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : October 10, 2012
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services

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.


Condition or disease
Total Ankle Prosthesis

Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Case-Only
Official Title: Short to Mid Term Follow-up of Patient Implanted With the HINTEGRA® Total Ankle Prosthesis
Study Start Date : February 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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



Primary Outcome Measures :
  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 Outcome Measures :
  1. AOFAS Ankle-Hindfoot Scale score (American Orthopaedic Foot and Ankle Society). [ Time Frame: more than 2 years after the implantation ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Integra LifeSciences Services
ClinicalTrials.gov Identifier: NCT01284972     History of Changes
Other Study ID Numbers: RECON-EMEA-02
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012