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

• Sponsor: Smith & Nephew, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03247023
• Collaborator: Smith & Nephew Orthopaedics AG (Industry)
• Enrollment: 61
• Locations: 6
• Anticipated Duration (Months): 143.4
• Patients Per Site: 10.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Degenerative Arthritis; Rheumatoid Arthritis; Traumatic Arthritis	Device: Implantation of Integra Cadence Total Ankle Sysyem

Study Design

• Study Type: Observational
• Actual Enrollment: 61 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
• Actual Study Start Date: Sep 18, 2017
• Actual Primary Completion Date: Dec 8, 2021
• Anticipated Study Completion Date: Sep 1, 2029

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Implant survivorship [2 years]

   Implant survival defined as absence of device removal or revision

Secondary Outcome Measures

1. 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

2. Relative change of Range of Motion (ROM) compared to baseline [up to 10 years]

   Relative change of ROM compared to baseline

3. 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

4. Relative change of Visual Analogue Scale (VAS) Pain compared to baseline [up to 10 years]

   Relative change of VAS Pain compared to baseline

5. 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

6. Implant survivorship [5 and 10 years]

   Implant survival defined as absence of device removal or revision

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Gent	Gent		Belgium	9000
2	Foot and Ankle Institute	Woluwe-St-Lambert		Belgium	B-1200
3	St. Michael's Hospital	Toronto		Canada	M5C 1R6
4	CHRU Tours	Tours		France	37044
5	Clinica Nostra Senhora del Remei	Barcelona		Spain	08024
6	North Cumbria University Hospitals	Carlisle		United Kingdom	CA2 7HY

Sponsors and Collaborators

• Smith & Nephew, Inc.
• Smith & Nephew Orthopaedics AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Smith & Nephew, Inc.
• ClinicalTrials.gov Identifier: NCT03247023
• Other Study ID Numbers: T-CTAS-002
• First Posted: Aug 11, 2017
• Last Update Posted: May 10, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Osteoarthritis

Study Results

No Results Posted as of May 10, 2022