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

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)

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis; Degenerative Arthritis; Traumatic Arthritis
• Intervention / Treatment: Device: Implantation of Integra Cadence Total Ankle Sysyem

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Woluwe-St-Lambert, Belgium, B-1200
    • Foot and Ankle Institute
• Canada
  • Toronto, Canada, M5C 1R6
    • St. Michael's Hospital
• France
  • Tours, France, 37044
    • CHRU Tours
• Spain
  • Barcelona, Spain, 08024
    • Clinica Nostra Senhora del Remei
• United Kingdom
  • Carlisle, United Kingdom, CA2 7HY
    • North Cumbria University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with ankle arthritis requiring total ankle replacement

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Integra Cadence Total Ankle System	Device: Implantation of Integra Cadence Total Ankle Sysyem; Primary Ankle Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survivorship	Implant survival defined as absence of device removal or revision	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline	Relative change of PROMIS PF - Mobility compared to baseline	up to 10 years
Relative change of Range of Motion (ROM) compared to baseline	Relative change of ROM compared to baseline	up to 10 years
Relative change of Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale compared to baseline	Relative change of FAAM ADL compared to baseline	up to 10 years
Relative change of Visual Analogue Scale (VAS) Pain compared to baseline	Relative change of VAS Pain compared to baseline	up to 10 years
Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) compared to baseline	Relative change of SF-36v2 compared to baseline	up to 10 years
Implant survivorship	Implant survival defined as absence of device removal or revision	5 and 10 years
Radiographic Success	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	up to 10 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Collaborators: Smith & Nephew Orthopaedics AG

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): December 8, 2021
• Study Completion (Actual): September 6, 2023

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: T-CTAS-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No