Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

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.

Study Overview

• Status: Withdrawn
• Conditions: Arthritis

• Study Type: Observational

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Katholieke Universiteit Leuven
  • Turnhout, Belgium
    • AZ Turnout - Clinic Sint-Jozef
• France
  • Aix en Provence, France
    • Clinique Axium
• Italy
  • Milan, Italy
    • I.R.C.C.S. Istituto Ortopedico Galeazzi
• Netherlands
  • Amsterdam, Netherlands
    • Sint Lucas Andreas Ziekenhuis
• Portugal
  • Matosinhos, Portugal
    • Hospital Pedro Hispano
• Spain
  • Barcelona, Spain
    • Hospital Clinico Y Provincial
• United Kingdom
  • Belfast, United Kingdom
    • Musgrave Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Total Ankle Arthroplasty
Tibiotalar Arthrodesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of reoperations in the total ankle replacement arm and in the tibiotalar arthrodesis arm	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.	after 5 years of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of reoperation in the tibiotalar arthrodesis arm and in the total ankle replacement arm	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	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	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	1, 2, 5, 7 and 10 years
The evolution and clinical outcomes	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	1, 2, 5, 7 and 10 years
the decision criteria for choosing the surgical technique use	Reason for choosing the Total ANkle Arthroplasty or Tibiotalar Arthrodesis	inclusion

Collaborators and Investigators

• Sponsor: Integra LifeSciences Services
• Investigators: Principal Investigator: Jeroen De Wachter, Az Turnhout

Study record dates

Study Major Dates

• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: December 31, 2013
• First Submitted That Met QC Criteria: December 31, 2013
• First Posted (Estimate): January 1, 2014

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 11, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: RECON-EMEA-12