NCT02025946WithdrawnNot Applicable
Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis
Integra LifeSciences Services8 sites in 7 countriesStarted: January 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 8
- Primary Endpoint
- proportion of reoperations in the total ankle replacement arm and in the tibiotalar arthrodesis arm
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Study Sites (8)
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