NCT01284972

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
6 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

January 26, 2011

Last Update Submit

October 9, 2012

Conditions

Total Ankle Prosthesis

Outcome Measures

Primary Outcomes (1)

  • rate of device related complications at the follow up after 2 years of implantation

    more than 2 years after the implantation

Secondary Outcomes (1)

  • AOFAS Ankle-Hindfoot Scale score (American Orthopaedic Foot and Ankle Society).

    more than 2 years after the implantation

Study Arms (1)

HINTEGRA

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medical University of Innsbruck

Innsbruck, A-6020, Austria

Location

St. Michael's Hospital

Toronto, M5C 1R6, Canada

Location

CHU d'Amiens - Hopital Nord

Amiens, 80054, France

Location

AukammKlinik

Wiesbaden, 65191, Germany

Location

Severance Hospital - Yonsei University

Seoul, South Korea

Location

Hopital San Rafael

Barcelona, 08035, Spain

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

February 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

ES(1)CA(1)FR(1)AU(1)DE(1)KR(1)