Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

Integra LifeSciences

Status: Withdrawn

Conditions: Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02025946

RECON-EMEA-12

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Total Ankle Arthroplasty

Tibiotalar Arthrodesis