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)
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Is \> 18 years of age.
. Is skeletally mature.
. 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).
. 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.
. Is willing and able to cooperate in the required post-operative therapy.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Reads, understands and signs the Ethical Committee approved Informed Consent or Information Letter and Data Transfer Authorization Form, as applicable
Exclusion criteria
. Is Morbidly Obese (defined by BMI \> 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
. 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.
. 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.
. 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.
. Has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
. Had previous ankle surgery and/or injury that has adversely affected the anklebone stock.
. Has had or is scheduled to have contralateral TAR surgery.