Clinical trial NCT03247023: Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
Official title: Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Arthritis
Rheumatoid Arthritis
Traumatic Arthritis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Smith & Nephew Orthopaedics AG
First posted: 2017-08-11
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with ankle arthritis requiring total ankle replacement

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)


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.

Primary outcomes:
measure: Implant survivorship
timeFrame: 2 years
Secondary outcomes:
measure: Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline
timeFrame: up to 10 years
measure: Relative change of Range of Motion (ROM) compared to baseline
timeFrame: up to 10 years
measure: Relative change of Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale compared to baseline
timeFrame: up to 10 years
measure: Relative change of Visual Analogue Scale (VAS) Pain compared to baseline
timeFrame: up to 10 years
measure: Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) compared to baseline
timeFrame: up to 10 years
measure: Implant survivorship
timeFrame: 5 and 10 years
measure: Radiographic Success
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Woluwe-St-Lambert
country: Belgium
facility: Foot and Ankle Institute
city: Toronto
country: Canada
facility: St. Michael's Hospital
city: Tours
country: France
facility: CHRU Tours
city: Barcelona
country: Spain
facility: Clinica Nostra Senhora del Remei
city: Carlisle
country: United Kingdom
facility: North Cumbria University Hospitals
Study officials:
References: