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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2023
• Main ID: NCT03247023
• Date of registration: 08/08/2017
• Prospective Registration: Yes
• Primary sponsor: Smith & Nephew, Inc.
• Public title: Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
• Scientific title: Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
• Date of first enrolment: September 18, 2017
• Target sample size: 61
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03247023
• Study type: Observational

Countries of recruitment

Belgium, Canada, France, Luxembourg, Spain, United Kingdom

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Degenerative Arthritis

Traumatic Arthritis

Rheumatoid Arthritis

Intervention(s)

Device: Implantation of Integra Cadence Total Ankle Sysyem

Primary Outcome(s)

Implant survivorship [Time Frame: 2 years]

Secondary Outcome(s)

Relative change of Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale compared to baseline [Time Frame: up to 10 years]

Relative change of Range of Motion (ROM) compared to baseline [Time Frame: up to 10 years]

Radiographic Success [Time Frame: up to 10 years]

Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline [Time Frame: up to 10 years]

Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) compared to baseline [Time Frame: up to 10 years]

Implant survivorship [Time Frame: 5 and 10 years]

Relative change of Visual Analogue Scale (VAS) Pain compared to baseline [Time Frame: up to 10 years]

Secondary ID(s)

T-CTAS-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Smith & Nephew Orthopaedics AG