Clinical trial NCT02025946: Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis
Official title: Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arthritis
Lead sponsor: Integra LifeSciences Services
Sponsor class: INDUSTRY
First posted: 2014-01-01
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: proportion of reoperations in the total ankle replacement arm and in the tibiotalar arthrodesis arm
timeFrame: after 5 years of follow-up
Secondary outcomes:
measure: Proportion of reoperation in the tibiotalar arthrodesis arm and in the total ankle replacement arm
timeFrame: 1, 2, 7 and 10 years
measure: proportion of revision for the whole study period in the tibiotalar arthrodesis arm and in the total ankle replacement arm
timeFrame: 1, 2, 5, 7 and 10 years
measure: The evolution and clinical outcomes
timeFrame: 1, 2, 5, 7 and 10 years
measure: the decision criteria for choosing the surgical technique use
timeFrame: inclusion
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
city: Turnhout
country: Belgium
facility: AZ Turnout - Clinic Sint-Jozef
city: Aix en Provence
country: France
facility: Clinique Axium
city: Milan
country: Italy
facility: I.R.C.C.S. Istituto Ortopedico Galeazzi
city: Amsterdam
country: Netherlands
facility: Sint Lucas Andreas Ziekenhuis
city: Matosinhos
country: Portugal
facility: Hospital Pedro Hispano
city: Barcelona
country: Spain
facility: Hospital clinico y provincial
city: Belfast
country: United Kingdom
facility: Musgrave Park Hospital
Study officials:
affiliation: AZ Turnhout
name: Jeroen De Wachter
role: PRINCIPAL_INVESTIGATOR
References: