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

Terminated

• Conditions: Degenerative Arthritis; Rheumatoid Arthritis; Traumatic Arthritis
• Interventions: Device: Implantation of Integra Cadence Total Ankle Sysyem

• Registration Number: NCT03247023
• Lead Sponsor: Smith & Nephew, Inc.

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Study Start: 2017-09-18
• Primary Completion: 2021-12-08
• Study Completion: 2023-09-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Integra Cadence Total Ankle System	Implantation of Integra Cadence Total Ankle Sysyem	-

Primary Outcome Measures

Name	Time	Method
Implant survivorship	2 years	Implant survival defined as absence of device removal or revision

Secondary Outcome Measures

Name	Time	Method
Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline	up to 10 years	Relative change of PROMIS PF - Mobility compared to baseline
Relative change of Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale compared to baseline	up to 10 years	Relative change of FAAM ADL compared to baseline
Implant survivorship	5 and 10 years	Implant survival defined as absence of device removal or revision
Radiographic Success	up to 10 years	Radiographic success as defined as absence of implant radiolucency, subsidence, tilting, migration defined as no evidence of radiolucency \>4 mm in more than 3 zones and of subsidence or tilting ˃4 degrees, or migration \> 4mm
Relative change of Range of Motion (ROM) compared to baseline	up to 10 years	Relative change of ROM compared to baseline
Relative change of Visual Analogue Scale (VAS) Pain compared to baseline	up to 10 years	Relative change of VAS Pain compared to baseline
Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) compared to baseline	up to 10 years	Relative change of SF-36v2 compared to baseline

Trial Locations

Locations (6)

Foot and Ankle Institute; 🇧🇪 Woluwe-St-Lambert, Belgium

St. Michael's Hospital; 🇨🇦 Toronto, Canada

CHRU Tours; 🇫🇷 Tours, France

North Cumbria University Hospitals; 🇬🇧 Carlisle, United Kingdom

Clinica Nostra Senhora del Remei; 🇪🇸 Barcelona, Spain

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium