This study will evaluate the long term performance and safety data for the Cadence™ Total Ankle System (CTAS) when used for primary arthroplasty in patients with primary arthritis (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved), and systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
Study Type
OBSERVATIONAL
Enrollment
61
Primary Ankle Arthroplasty
Universitair Ziekenhuis Gent
Ghent, Belgium
Foot and Ankle Institute
Woluwe-St-Lambert, Belgium
St. Michael's Hospital
Toronto, Canada
CHRU Tours
Tours, France
Implant survivorship
Implant survival defined as absence of device removal or revision
Time frame: 2 years
Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline
Relative change of PROMIS PF - Mobility compared to baseline
Time frame: up to 10 years
Relative change of Range of Motion (ROM) compared to baseline
Relative change of ROM compared to baseline
Time frame: up to 10 years
Relative change of Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale compared to baseline
Relative change of FAAM ADL compared to baseline
Time frame: up to 10 years
Relative change of Visual Analogue Scale (VAS) Pain compared to baseline
Relative change of VAS Pain compared to baseline
Time frame: up to 10 years
Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) compared to baseline
Relative change of SF-36v2 compared to baseline
Time frame: up to 10 years
Implant survivorship
Implant survival defined as absence of device removal or revision
Time frame: 5 and 10 years
Radiographic Success
Radiographic success as defined as absence of implant radiolucency, subsidence, tilting, migration defined as no evidence of radiolucency \>4 mm in more than 3 zones and of subsidence or tilting ˃4 degrees, or migration \> 4mm
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Clinica Nostra Senhora del Remei
Barcelona, Spain
North Cumbria University Hospitals
Carlisle, United Kingdom
Time frame: up to 10 years