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

January 26, 2011
October 9, 2012
February 2009
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01284972 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case-Only
Not Provided
Not Provided
Non-Probability Sample

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

Total Ankle Prosthesis
Not Provided
HINTEGRA
Patient Implanted with the HINTEGRA Total Ankle Prosthesis more than 2 years ago
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Canada,   France,   Germany,   Korea, Republic of,   Spain
 
NCT01284972
RECON-EMEA-02
No
Integra LifeSciences Services
Integra LifeSciences Services
Not Provided
Not Provided
Integra LifeSciences Services
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP