Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

Integra LifeSciences Services8 sites in 7 countriesJanuary 1, 2014

ConditionsArthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arthritis
Sponsor: Integra LifeSciences Services
Locations: 8
Primary Endpoint: proportion of reoperations in the total ankle replacement arm and in the tibiotalar arthrodesis arm
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is the better solution for end stage ankle arthritis.

The purpose of the present study is to analyze patient's outcome after each type of ankle surgery and to describe the decision making process.

Registry

clinicaltrials.gov

Start Date

January 1, 2014

End Date

January 2026

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Integra LifeSciences Services

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient with isolated symptomatic end-stage ankle arthritis who needs a tibiotalar arthrodesis or a mobile-bearing total ankle arthroplasty
•Patient receiving CE marked medical devices and planned to be operated in compliance with their respective Instructions for Use
•Patient aged between 40 and 75 years old

Exclusion Criteria

•Patient who already had before his inclusion in this study a tibiotalar arthrodesis or a total ankle arthroplasty in the same ankle
•Patient with planned or existing arthrodesis of adjacent joints (subtalar, talonavicular and calcaneaocuboid joint)
•Patient with ankle deformity \> 20° (weight bearing X-rays)
•Patient with history of infection of the ankle joint (positive culture) or current infection of the ankle joint (positive culture)
•Patient with neuropathy or with a history of diabetes mellitus for more than 15 years
•Patient with avascular necrosis of the talus \>25%
•Patient already included in the study for the other ankle

Outcomes

Primary Outcomes

proportion of reoperations in the total ankle replacement arm and in the tibiotalar arthrodesis arm

Time Frame: after 5 years of follow-up

Reoperation will be defined as any secondary surgery related to the operated ankle or adjacent joints (subtalar, talonavicular and calcaneocuboid joints), excluding wound healing problems.

Secondary Outcomes

The evolution and clinical outcomes(1, 2, 5, 7 and 10 years)
Proportion of reoperation in the tibiotalar arthrodesis arm and in the total ankle replacement arm(1, 2, 7 and 10 years)
proportion of revision for the whole study period in the tibiotalar arthrodesis arm and in the total ankle replacement arm(1, 2, 5, 7 and 10 years)
the decision criteria for choosing the surgical technique use(inclusion)