Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)

Study Overview
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Brief Summary
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A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.

Official Title
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A Post-Market, Prospective, Non-Randomized, Multi-Center, Open-Label, Clinical Evaluation of the Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement

Conditions
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Rheumatoid Arthritis, Degenerative Arthritis, Post Traumatic Arthritis

Intervention / Treatment
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* Device: Integra Cadence Total Ankle System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is skeletally mature. The patient 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). The patient is willing and able to complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent. The patient reads, understands and signs the Institutional Review Board (IRB) approved Informed Consent. Exclusion Criteria: The patient is Morbidly Obese (defined by Body Mass Index (BMI) > 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight). The patient 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. The patient has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection. The patient has a condition that may impair proper wound healing (e.g., poor soft tissue envelope). The patient is pregnant or plans to become pregnant during the follow up period. The patient 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. The patient has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy). The patient 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Integra® Cadence™ Total Ankle System<br> | Device: Integra Cadence Total Ankle System<br>* Primary or revision on total ankle replacement<br>* Other names: Primary Ankle Arthroplasty;|

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) compared to baseline | Relative change of FAAM compared to baseline | up to 10 Years | 
| Relative change of Pain compared to baseline | Relative change of Visual Analogue Scale Pain compared to baseline | up to 10 Years | 
| Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) | 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 |