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

NCT03247023 | Terminated Results

• 1 other identifier: T-CTAS-002
• Study Type: observational
• Target: 65
• Locations: 5 countries
• Sites: 6

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)

Conditions

Degenerative Arthritis; Rheumatoid Arthritis; Traumatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Implant Survivorship at 2 Years

  Implant survivorship determined by the percentage of participants with survival of the device. Successful device survival was defined as absence of device removal or revision.

  2 years

Secondary Outcomes (18)

• Implant Survivorship at 5 Years and 10 Years

  5 years and 10 years

• Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility

  Baseline, 3 months, 6 months, 1 year, 2 years, 5 years

• Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale

  Baseline, 3 months, 6 months, 1 year, 2 years, 5 years

• Visual Analogue Scale (VAS) Pain Score: Resting

  Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years

• Visual Analogue Scale (VAS) Pain Score: Activity

  Baseline, 3 months, 6 months, 1 year, 2 years, 5 years

Study Arms (1)

Integra Cadence Total Ankle System

Device: Implantation of Integra Cadence Total Ankle System

Interventions

Implantation of Integra Cadence Total Ankle System DEVICE

Primary Ankle Arthroplasty

Integra Cadence Total Ankle System

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with ankle arthritis requiring total ankle replacement

You may qualify if:

• Subjects will be included if he/she:
• Is \> 18 years of age.
• Is skeletally mature.
• Qualifies for primary 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 CTAS 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 cooperate in the required post-operative therapy.
• 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.
• Reads, understands and signs the Ethical Committee approved Informed Consent or Information Letter and Data Transfer Authorization Form, as applicable

You may not qualify if:

• Subjects will be excluded from the study if he/she:
• Is Morbidly Obese (defined by BMI \> 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
• Is an active nicotine user (smoking, chewing, smokeless tobacco, patch) and unwilling to cease nicotine use within 1 month prior to surgery, and 2 months post-surgery.
• 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.
• Continues on long-term medication, which may compromise bone stock (e.g. undergoing immunosuppressive therapy, long-term steroids) and is unable to cease medication usage from 3 weeks prior to surgery to 3 weeks post-surgery.
• Has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
• Had previous ankle surgery and/or injury that has adversely affected the anklebone stock.
• Has had or is scheduled to have contralateral TAR surgery.
• Is pregnant or plans to become pregnant during the follow up period.
• 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 severe avascular necrosis of the talus/tibia.
• 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.
• Is a poor candidate for general anesthesia.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead
• Smith & Nephew Orthopaedics AG: collaborator

Study Sites (6)

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Foot and Ankle Institute

Woluwe-St-Lambert, B-1200, Belgium

Location

St. Michael's Hospital

Toronto, M5C 1R6, Canada

Location

CHRU Tours

Tours, 37044, France

Location

Clinica Nostra Senhora del Remei

Barcelona, 08024, Spain

Location

North Cumbria University Hospitals

Carlisle, CA2 7HY, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Due to early termination of the study, a small number of participants were analyzed following the 2-year time frame. No participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

+41 (0)41 766 22 22

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 11, 2017
• Study Start: September 18, 2017
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: June 22, 2026
• Results First Posted: June 22, 2026

Record last verified: 2024-12

Locations

ES (1); CA (1); BE (2); GB (1); FR (1)