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

Smith & Nephew

Status: Terminated

Conditions: Traumatic Arthritis; Degenerative Arthritis; Rheumatoid Arthritis

Treatments: Device: Implantation of Integra Cadence Total Ankle Sysyem

Study type: Observational

Funder types: Industry

Identifiers

NCT03247023

T-CTAS-002

Details and patient eligibility

About

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)

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects will be included if he/she:

• 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).
• Is suitable for TAR with Cadence™ Total Ankle System 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 complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent (or Information Letter and Data Transfer Authorization Form, as applicable).

Exclusion criteria

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

• Is morbidly obese (defined by a Body Mass Index (BMI) > 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
• 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.
• Has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
• 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.
• Has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).
• Has a known sensitivity or allergic reaction to one or more of the implanted materials.

Trial design

61 participants in 1 patient group

Integra Cadence Total Ankle System

Treatment:

Device: Implantation of Integra Cadence Total Ankle Sysyem