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



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:August 24, 2017
End Date:February 2029
Contact:Jeremy L West
Email:jeremy.west@integralife.com
Phone:609-936-5539

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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.


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.
We found this trial at
10
sites
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Buffalo, New York 14215
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Buffalo, NY
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Calgary,
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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San Francisco, California 94115
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San Francisco, CA
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2030 Bee Ridge Road
Sarasota, Florida 34239
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Sarasota, FL
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11315 Bridgeport Way Southwest
Seattle, Washington 98402
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Seattle, WA
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300 Polaris Parkway
Westerville, Ohio 43082
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Westerville, OH
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