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Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement | Clinical Trials | Clareo Health

TERMINATED

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

NCT03247023•Smith & Nephew, Inc.

View on ClinicalTrials.gov

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 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)

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (6)

Universitair Ziekenhuis Gent

Ghent, Belgium

Foot and Ankle Institute

Woluwe-St-Lambert, Belgium

St. Michael's Hospital

Toronto, Canada

CHRU Tours

Tours, France

Clinica Nostra Senhora del Remei

Barcelona, Spain

North Cumbria University Hospitals

Carlisle, United Kingdom

Key Dates

Start Date

September 18, 2017

Primary Completion Date

December 8, 2021

Completion Date

September 6, 2023

Last Updated

September 4, 2025

Enrollment

ACTUAL participants

Conditions

Degenerative ArthritisRheumatoid ArthritisTraumatic Arthritis

Interventions

Implantation of Integra Cadence Total Ankle Sysyem

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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