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

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: NCT03247023
Recruitment Status : Active, not recruiting
First Posted : August 11, 2017
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Integra LifeSciences Services
Information provided by (Responsible Party):
Integra LifeSciences Corporation

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)

Condition or disease Intervention/treatment
Degenerative Arthritis Rheumatoid Arthritis Traumatic Arthritis Device: Implantation of Integra Cadence Total Ankle Sysyem

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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2029

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Integra Cadence Total Ankle System Device: Implantation of Integra Cadence Total Ankle Sysyem
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) Activities of Daily Living (ADL) subscale compared to baseline [ Time Frame: up to 10 years ]
    Relative change of FAAM ADL compared to baseline

  4. Relative change of Visual Analogue Scale (VAS) Pain compared to baseline [ Time Frame: up to 10 years ]
    Relative change of VAS Pain compared to baseline

  5. Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) compared to baseline [ 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
Sampling Method:   Non-Probability Sample
Study Population
Patient with ankle arthritis requiring total ankle replacement
Criteria

Inclusion Criteria:

Subjects will be included if he/she:

  • 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).
  • Is suitable for TAR with Cadence™ Total Ankle System 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 complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent (or Information Letter and Data Transfer Authorization Form, as applicable).

Exclusion Criteria:

Subjects will be excluded from the study if he/she:

  • Is morbidly obese (defined by a Body Mass Index (BMI) > 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
  • 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.
  • Has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
  • 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 inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).
  • 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): NCT03247023


Locations
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Belgium
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Foot and Ankle Institute
Woluwe-St-Lambert, Belgium, B-1200
Canada
St. Michael's Hospital
Toronto, Canada, M5C 1R6
France
CHRU Tours
Tours, France, 37044
Spain
Clinica Nostra Senhora del Remei
Barcelona, Spain, 08024
United Kingdom
North Cumbria University Hospitals
Carlisle, United Kingdom, CA2 7HY
Sponsors and Collaborators
Integra LifeSciences Corporation
Integra LifeSciences Services
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Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT03247023    
Other Study ID Numbers: T-CTAS-002
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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