Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

Withdrawn

• Conditions: Arthritis

• Registration Number: NCT02025946
• Lead Sponsor: Integra LifeSciences Services

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-31
• Study First Submitted QC: 2013-12-31
• Study First Posted: 2014-01-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13
• Primary Completion: 2021-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of reoperations in the total ankle replacement arm and in the tibiotalar arthrodesis arm	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 Outcome Measures

Name	Time	Method
The evolution and clinical outcomes	1, 2, 5, 7 and 10 years	* Pain measured using a Visual Analog Scale (VAS); * Ankle function measured using the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale; * Level of activity measured using the University of California, Los Angeles (UCLA) activity scale; * Quality of life measured using the EQ5D™ questionnaire; * Arthritis status of adjacent joints measured using the Kellgren-Lawrence grading scale; * Patient satisfaction
Proportion of reoperation in the tibiotalar arthrodesis arm and in the total ankle replacement arm	1, 2, 7 and 10 years	The proportion of reoperation as defined above and for the whole study period in the tibiotalar arthrodesis arm and in the total ankle replacement arm
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	For the arthrodesis arm, a revision will be defined as a reoperation for one of the following reasons: nonunion or pseudoarthrosis or malunion. Hardware removal will not be considered as a revision.; For the total ankle arthroplasty arm, a revision will be defined as the change of any metallic component of the implanted device. The incidental change of the polyethylene will not be considered as a revision except when it is broken without any
the decision criteria for choosing the surgical technique use	inclusion	Reason for choosing the Total ANkle Arthroplasty or Tibiotalar Arthrodesis

Trial Locations

Locations (8)

Katholieke Universiteit Leuven; 🇧🇪 Leuven, Belgium

I.R.C.C.S. Istituto Ortopedico Galeazzi; 🇮🇹 Milan, Italy

AZ Turnout - Clinic Sint-Jozef; 🇧🇪 Turnhout, Belgium

Clinique Axium; 🇫🇷 Aix en Provence, France

Sint Lucas Andreas Ziekenhuis; 🇳🇱 Amsterdam, Netherlands

Musgrave Park Hospital; 🇬🇧 Belfast, United Kingdom

Hospital clinico y provincial; 🇪🇸 Barcelona, Spain

Hospital Pedro Hispano; 🇵🇹 Matosinhos, Portugal