Status:
TERMINATED
Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
Lead Sponsor:
Smith & Nephew, Inc.
Collaborating Sponsors:
Smith & Nephew Orthopaedics AG
Conditions:
Degenerative Arthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 18 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 6 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03247023
Start Date
September 18 2017
End Date
September 6 2023
Last Update
September 4 2025
Active Locations (6)
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1
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
2
Foot and Ankle Institute
Woluwe-St-Lambert, Belgium, B-1200
3
St. Michael's Hospital
Toronto, Canada, M5C 1R6
4
CHRU Tours
Tours, France, 37044