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

Sponsor
Smith & Nephew, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03142958
Collaborator
(none)
132
Enrollment
11
Locations
1
Arm
137.3
Anticipated Duration (Months)
12
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Integra Cadence Total Ankle System
 N/A

Study Design

Study Type:
Interventional
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 :
Aug 24, 2017
Anticipated Primary Completion Date :
Feb 1, 2029
Anticipated Study Completion Date :
Feb 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Other: Integra® Cadence™ Total Ankle System

Device: Integra Cadence Total Ankle System
Primary or revision on total ankle replacement
Other Names:
  • Primary Ankle Arthroplasty

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Implant Survivorship [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 [up to 10 Years]

      Relative change of PROMIS PF - Mobility compared to baseline

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

      Relative change of ROM compared to baseline

    3. Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline [up to 10 Years]

      Relative change of FAAM compared to baseline

    4. Relative change of Pain compared to baseline [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) [up to 10 Years]

      Relative change of SF-36v2 compared to baseline

    6. Implant Survivorship [5 and 10 Years]

      Implant survival defined as absence of device removal or revision.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Smith & Nephew, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Smith & Nephew, Inc.
    ClinicalTrials.gov Identifier:
    NCT03142958
    Other Study ID Numbers:
    • T-CTAS-001
    First Posted:
    May 8, 2017
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Arthritis
    Osteoarthritis

    Study Results

    No Results Posted as of Feb 9, 2022