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

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

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)

Inclusion Criteria:

Subjects will be included if he/she:

1. Is > 18 years of age.
2. Is skeletally mature.
3. Qualifies for primary 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).
4. Is suitable for TAR with CTAS per the study surgeon based on the product indication and having considered deformity, stability, bone quality, soft- tissue envelope, and neurovascular status.
5. Is willing and able to cooperate in the required post-operative therapy.
6. 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.
7. Reads, understands and signs the Ethical Committee approved Informed Consent or Information Letter and Data Transfer Authorization Form, as applicable

Exclusion Criteria:

Subjects will be excluded from the study if he/she:

1. Is Morbidly Obese (defined by BMI > 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
2. Is an active nicotine user (smoking, chewing, smokeless tobacco, patch) and unwilling to cease nicotine use within 1 month prior to surgery, and 2 months post-surgery.
3. 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.
4. Has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection.
5. Continues on long-term medication, which may compromise bone stock (e.g. undergoing immunosuppressive therapy, long-term steroids) and is unable to cease medication usage from 3 weeks prior to surgery to 3 weeks post-surgery.
6. Has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
7. Had previous ankle surgery and/or injury that has adversely affected the anklebone stock.
8. Has had or is scheduled to have contralateral TAR surgery.
9. Is pregnant or plans to become pregnant during the follow up period.
10. 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.
11. Has severe avascular necrosis of the talus/tibia.
12. Has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).
13. Has a known sensitivity or allergic reaction to one or more of the implanted materials.
14. Is a poor candidate for general anesthesia.
15. Is a prisoner, mentally incompetent or unable to understand what participation in this study entails, a known alcohol or drug abuser, or anticipated to be non- compliant.