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

February 29, 2024 updated by: Smith & Nephew, Inc.

A Post-Market, Prospective, Non-Randomized, Multi-Center, Open-Label, Clinical Evaluation of the Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T3M 1M4
        • Calgary - South Health Campus
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Providence St. Joseph's and St. Michael's Healthcare
    • California
      • San Francisco, California, United States, 94118
        • Kaiser Permanente
    • Florida
      • Sarasota, Florida, United States, 34239
        • Florida Orthopedic Foot and Ankle Center
    • New York
      • Buffalo, New York, United States, 14215
        • State University of Ney York - Buffalo
    • North Carolina
      • Durham, North Carolina, United States, 27703
        • Duke University
    • Ohio
      • Westerville, Ohio, United States, 43082
        • OhioHealth Research Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 49525
        • Rothman Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98402
        • Catholic Health Initiatives

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Integra® Cadence™ Total Ankle System
Primary or revision on total ankle replacement
Other Names:
  • Primary Ankle Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survivorship
Time Frame: 2 years
Implant survival defined as absence of device removal or revision.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline
Time Frame: up to 10 Years
Relative change of PROMIS PF - Mobility compared to baseline
up to 10 Years
Relative change of Range Of Motion (ROM) compared to baseline
Time Frame: up to 10 Years
Relative change of ROM compared to baseline
up to 10 Years
Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline
Time Frame: up to 10 Years
Relative change of FAAM compared to baseline
up to 10 Years
Relative change of Pain compared to baseline
Time Frame: up to 10 Years
Relative change of Visual Analogue Scale Pain compared to baseline
up to 10 Years
Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2)
Time Frame: up to 10 Years
Relative change of SF-36v2 compared to baseline
up to 10 Years
Implant Survivorship
Time Frame: 5 and 10 Years
Implant survival defined as absence of device removal or revision.
5 and 10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Timothy Daniels, MD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2017

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • T-CTAS-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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