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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03142958
Recruitment Status : Active, not recruiting
First Posted : May 8, 2017
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Degenerative Arthritis Post Traumatic Arthritis Device: Integra Cadence Total Ankle System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-Market, Prospective, Non-Randomized, Multi-Center, Open-Label, Clinical Evaluation of the Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
Actual Study Start Date : August 24, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Integra® Cadence™ Total Ankle System Device: Integra Cadence Total Ankle System
Primary or revision on total ankle replacement
Other Name: Primary Ankle Arthroplasty




Primary Outcome Measures :
  1. Implant Survivorship [ Time Frame: 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 [ Time Frame: up to 10 Years ]
    Relative change of PROMIS PF - Mobility compared to baseline

  2. Relative change of Range Of Motion (ROM) compared to baseline [ Time Frame: up to 10 Years ]
    Relative change of ROM compared to baseline

  3. 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

  4. Relative change of Pain compared to baseline [ Time Frame: up to 10 Years ]
    Relative change of Visual Analogue Scale Pain compared to baseline

  5. 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

  6. Implant Survivorship [ Time Frame: 5 and 10 Years ]
    Implant survival defined as absence of device removal or revision.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142958


Locations
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United States, California
Kaiser Permanente
San Francisco, California, United States, 94118
United States, Florida
Florida Orthopedic Foot and Ankle Center
Sarasota, Florida, United States, 34239
United States, New York
State University of Ney York - Buffalo
Buffalo, New York, United States, 14215
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27703
United States, Ohio
OhioHealth Research Institute
Westerville, Ohio, United States, 43082
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 49525
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Catholic Health Initiatives
Seattle, Washington, United States, 98402
Canada, Alberta
Calgary - South Health Campus
Calgary, Alberta, Canada, T3M 1M4
Canada, Ontario
Providence St. Joseph's and St. Michael's Healthcare
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Integra LifeSciences Corporation
Investigators
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Principal Investigator: Timothy Daniels, MD University of Toronto
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Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT03142958    
Other Study ID Numbers: T-CTAS-001
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases