- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03142958
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
Status
Suspended
Intervention / Treatment
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
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-
-
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California
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San Francisco, California, United States, 94118
- Kaiser Permanente
-
-
Florida
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Sarasota, Florida, United States, 34239
- Florida Orthopedic Foot and Ankle Center
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-
New York
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Buffalo, New York, United States, 14215
- State University of Ney York - Buffalo
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North Carolina
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Durham, North Carolina, United States, 27703
- Duke University
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Ohio
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Westerville, Ohio, United States, 43082
- OhioHealth Research Institute
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-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 49525
- Rothman Institute
-
-
Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Washington
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Seattle, Washington, United States, 98104
- Harborview Medical Center
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Seattle, Washington, United States, 98402
- Catholic Health Initiatives
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-
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:
|
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
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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.
Sponsor
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
Additional Relevant MeSH Terms
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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-
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Clinical Trials on Integra Cadence Total Ankle System
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Smith & Nephew, Inc.Smith & Nephew Orthopaedics AGTerminatedRheumatoid Arthritis | Degenerative Arthritis | Traumatic ArthritisBelgium, France, Canada, Spain, United Kingdom
-
Unity Health TorontoUnknown
-
Zimmer BiometActive, not recruitingRheumatoid Arthritis | Degenerative Arthritis | Post Traumatic ArthritisUnited States, Switzerland, Canada, Finland, Germany, Italy
-
Stryker Trauma GmbHCompleted
-
Encore Medical, L.P.CompletedOsteoarthritis | Rheumatoid Arthritis | Post Traumatic Arthritis | Primary ArthrosisUnited States
-
Smith & Nephew, Inc.TerminatedArthritis | Rheumatoid Arthritis | Avascular Necrosis | Joint Instability | Fracture | Pain, Shoulder | Arthritis, Degenerative | Post-traumatic Arthrosis of Other Joints, Shoulder Region | Rotator Cuff Syndrome of Shoulder and Allied Disorders | Joint Trauma | Dislocation, ShoulderUnited States
-
Seattle Institute for Biomedical and Clinical ResearchNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsActive, not recruitingOsteoarthritis (OA) | End-stage Ankle Arthritis (ESAA)United States
-
Duke UniversityCompletedAnkle OsteoarthritisUnited States
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Istituto Ortopedico RizzoliRecruiting