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

NCT ID: NCT03247023

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2023-09-06

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 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)

Conditions

Degenerative Arthritis; Rheumatoid Arthritis; Traumatic Arthritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Integra Cadence Total Ankle System

Implantation of Integra Cadence Total Ankle Sysyem

Intervention Type: DEVICE

Primary Ankle Arthroplasty

Interventions

Implantation of Integra Cadence Total Ankle Sysyem

Primary Ankle Arthroplasty

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew Orthopaedics AG

INDUSTRY

Sponsor Role: collaborator

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Belgium; Canada; France; Spain; United Kingdom

Other Identifiers

T-CTAS-002

Identifier Type: -

Identifier Source: org_study_id