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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 26, 2011
Last Updated Date	October 9, 2012
Start Date ^ICMJE	February 2009
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 26, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01284972 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 26, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	HINTEGRA Total Ankle Prosthesis Follow-up
Official Title ^ICMJE	Short to Mid Term Follow-up of Patient Implanted With the HINTEGRA® 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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
Condition ^ICMJE	Total Ankle Prosthesis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	HINTEGRA Patient Implanted with the HINTEGRA Total Ankle Prosthesis more than 2 years ago
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	225
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria, Canada, France, Germany, Korea, Republic of, Spain

Administrative Information
NCT Number ^ICMJE	NCT01284972
Other Study ID Numbers ^ICMJE	RECON-EMEA-02
Has Data Monitoring Committee	No
Responsible Party	Integra LifeSciences Services
Study Sponsor ^ICMJE	Integra LifeSciences Services
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Integra LifeSciences Services
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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