Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement

Study Overview
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Brief Summary
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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)

Official Title
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Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement

Conditions
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Degenerative Arthritis, Rheumatoid Arthritis, Traumatic Arthritis

Intervention / Treatment
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* Device: Implantation of Integra Cadence Total Ankle Sysyem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be included if he/she: Qualifies for primary Total Ankle Replacement (TAR) per the surgeon and has a diagnosis of one of the following: primary arthritis (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved), or systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis). Is suitable for TAR with Cadence™ Total Ankle System per the study surgeon based on the product indication and having considered deformity, stability, bone quality, soft- tissue envelope, and neurovascular status. Is willing and able to complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent (or Information Letter and Data Transfer Authorization Form, as applicable). Exclusion Criteria: Subjects will be excluded from the study if he/she: Is morbidly obese (defined by a Body Mass Index (BMI) > 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight). Has one of the following conditions, which could compromise the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological (Charcot's Arthropathy) or vascular disease, loss of musculature or neuromuscular compromise. Has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection. Has a condition that may impair proper wound healing (e.g., poor soft tissue envelope). Has a metabolic disorder or disease that may compromise bone quality (e.g. arthrogryposis etc.), physiological or anatomical anomalies, and/or malignancy/local bone tumors. Has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy). Has a known sensitivity or allergic reaction to one or more of the implanted materials.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Integra Cadence Total Ankle System<br> | Device: Implantation of Integra Cadence Total Ankle Sysyem<br>* Primary Ankle Arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survivorship | Implant survival defined as absence of device removal or revision | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 10 years | 
| Relative change of Range of Motion (ROM) compared to baseline | Relative change of ROM compared to baseline | 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 | up to 10 years | 
| Relative change of Visual Analogue Scale (VAS) Pain compared to baseline | Relative change of VAS Pain compared to baseline | 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 | up to 10 years | 
| Implant survivorship | Implant survival defined as absence of device removal or revision | 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 | up to 10 years |