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

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Conditions studied: Rheumatoid Arthritis, Degenerative Arthritis, Post Traumatic Arthritis

In brief

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.

Key facts

Study ID

NCT03142958

Run by

Smith & Nephew, Inc.

People needed

132

Starts

2017-08-24

Expected to finish

2025-04-30

Last updated by the study team

2024-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kaiser Permanente — San Francisco, California, United States
• Florida Orthopedic Foot and Ankle Center — Sarasota, Florida, United States
• State University of Ney York - Buffalo — Buffalo, New York, United States
• Duke University — Durham, North Carolina, United States
• OhioHealth Research Institute — Westerville, Ohio, United States
• Rothman Institute — Philadelphia, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States
• Harborview Medical Center — Seattle, Washington, United States
• Catholic Health Initiatives — Seattle, Washington, United States
• Calgary - South Health Campus — Calgary, Alberta, Canada
• Providence St. Joseph's and St. Michael's Healthcare — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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