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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03247023
• Other study ID #: T-CTAS-002
• Status: Terminated
• Start date: September 18, 2017
• Est. completion date: September 6, 2023

Study information

• Verified date: September 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: September 6, 2023
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Degenerative Arthritis
• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis

Intervention

Device:
• Implantation of Integra Cadence Total Ankle Sysyem
Primary Ankle Arthroplasty

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Foot and Ankle Institute	Woluwe-St-Lambert
Canada	St. Michael's Hospital	Toronto
France	CHRU Tours	Tours
Spain	Clinica Nostra Senhora del Remei	Barcelona
United Kingdom	North Cumbria University Hospitals	Carlisle

Sponsors (2)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.	Smith & Nephew Orthopaedics AG

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survivorship	Implant survival defined as absence of device removal or revision	2 years
Secondary	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
Secondary	Relative change of Range of Motion (ROM) compared to baseline	Relative change of ROM compared to baseline	up to 10 years
Secondary	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
Secondary	Relative change of Visual Analogue Scale (VAS) Pain compared to baseline	Relative change of VAS Pain compared to baseline	up to 10 years
Secondary	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
Secondary	Implant survivorship	Implant survival defined as absence of device removal or revision	5 and 10 years
Secondary	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