Clinical Evaluation of Integra® Cadence⢠Total Ankle System in Primary Ankle Joint Replacement (C⦠(NCT03142958) | Clinical Trial Compass
SuspendedNot Applicable
Clinical Evaluation of Integra® Cadence⢠Total Ankle System in Primary Ankle Joint Replacement (CADENCE)
Stopped: Prematurely terminated -Sponsor decision not due to adverse events, complications, or device issues. Final data collection underway.
United States132 participantsStarted 2017-08-24
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 qualiā¦