HINTEGRA Total Ankle Prosthesis Follow-up

Total Ankle Prosthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284972
• Other study ID #: RECON-EMEA-02
• Status: Completed
• Phase: N/A
• First received: January 26, 2011
• Last updated: October 9, 2012
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2012
• Source: Integra LifeSciences Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeAustria: EthikkommissionGermany: Ethics CommissionSpain: Comité Ético de Investigación ClínicaFrance: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Total Ankle Prosthesis

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
Canada	St. Michael's Hospital	Toronto
France	CHU d'Amiens - Hopital Nord	Amiens
Germany	AukammKlinik	Wiesbaden
Korea, Republic of	Severance Hospital - Yonsei University	Seoul
Spain	Hopital San Rafael	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Services

Countries where clinical trial is conducted

Austria,  Canada,  France,  Germany,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of device related complications at the follow up after 2 years of implantation		more than 2 years after the implantation	Yes
Secondary	AOFAS Ankle-Hindfoot Scale score (American Orthopaedic Foot and Ankle Society).		more than 2 years after the implantation	No