Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)

NCT03142958 | Suspended FDA Device

• 1 other identifier: T-CTAS-001
• Study Type: observational
• Target: 132
• Locations: 2 countries
• Sites: 11

Brief Summary

A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.

Conditions

Rheumatoid Arthritis; Degenerative Arthritis; Post Traumatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Implant Survivorship

  Implant survival defined as absence of device removal or revision.

  2 years

Secondary Outcomes (6)

• Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline

  up to 10 Years

• Relative change of Range Of Motion (ROM) compared to baseline

  up to 10 Years

• Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline

  up to 10 Years

• Relative change of Pain compared to baseline

  up to 10 Years

• Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2)

  up to 10 Years

Study Arms (1)

Integra® Cadence™ Total Ankle System

Device: Integra Cadence Total Ankle System

Interventions

Integra Cadence Total Ankle System DEVICE

Primary or revision on total ankle replacement

Also known as: Primary Ankle Arthroplasty

Integra® Cadence™ Total Ankle System

Eligibility Criteria

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

Study Population

Patients enrolled in this study will have will have at least one of the indications listed below and meet all of the inclusion criteria. Patients meeting any of the exclusion criteria are not eligible for this study. The Integra® Cadence™ Total Ankle System (CTAS) is indicated for use to treat: * Primary arthritis (e.g. degenerative disease) * Secondary arthritis (e.g. Post-Traumatic, Avascular Necrosis, if minimally 2/3 of the talus is preserved) * Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis). The CTAS is also indicated for revision surgeries following failed total ankle replacement (TAR) and non-union/mal-union of ankle arthrodesis, provided sufficient bone stock is present.

You may qualify if:

• The patient is skeletally mature.
• The patient 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).
• The patient is willing and able to complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent.
• The patient reads, understands and signs the Institutional Review Board (IRB) approved Informed Consent.

You may not qualify if:

• The patient is Morbidly Obese (defined by Body Mass Index (BMI) \> 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
• The patient 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.
• The patient has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection.
• The patient has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
• The patient is pregnant or plans to become pregnant during the follow up period.
• The patient 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.
• The patient has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).
• The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (11)

Kaiser Permanente

San Francisco, California, 94118, United States

Location

Florida Orthopedic Foot and Ankle Center

Sarasota, Florida, 34239, United States

Location

State University of Ney York - Buffalo

Buffalo, New York, 14215, United States

Location

Duke University

Durham, North Carolina, 27703, United States

Location

OhioHealth Research Institute

Westerville, Ohio, 43082, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 49525, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Catholic Health Initiatives

Seattle, Washington, 98402, United States

Location

Calgary - South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

Providence St. Joseph's and St. Michael's Healthcare

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis

Condition Hierarchy (Ancestors)

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

Study Officials

• Timothy Daniels, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 8, 2017
• Study Start: August 24, 2017
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

CA (2); US (9)