Arthritis
Conditions
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.
Interventions
None listed
Sponsors
Integra LifeSciences Services
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| the decision criteria for choosing the surgical technique use | inclusion | Reason for choosing the Total ANkle Arthroplasty or Tibiotalar Arthrodesis |
Countries
Belgium, France, Italy, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed