Triathlon Tritanium Knee Outcomes Study



Status:Active, not recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 75
Updated:4/22/2018
Start Date:October 2014
End Date:May 2026

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The success rate of the Triathlon Tritanium Knee, defined as absence of revision for aseptic
loosening of the tibial baseplate at 2 years, is no worse than rates reported in the
literature for cemented devices.


Inclusion Criteria:

1. Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved;
study specific Informed Patient Consent Form.

2. Patient is a male or non-pregnant female age 18-75 years at time of study device
implantation.

3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).

4. Patient is a candidate for primary cementless total knee replacement, including a
resurfaced patella.

5. Patient is willing and able to comply with postoperative scheduled clinical and
radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Patient has a Body Mass Index (BMI) > 40.

2. Patient has a diagnosis of avascular necrosis or inflammatory arthritis.

3. Patient has an active or suspected latent infection in or about the affected knee
joint at time of study device implantation.

4. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to
evaluate the safety and efficacy of the device.

5. Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic
disorder (e.g. Paget's Disease) leading to progressive bone deterioration.

6. Patient is immunologically suppressed or receiving steroids in excess of normal
physiological requirements (e.g. > 30 days).

7. Patient is diagnosed with lumbar radicular pain.

8. Patient has a known sensitivity to device materials.

9. Patient is a prisoner.
We found this trial at
10
sites
Asheville, North Carolina 28801
Principal Investigator: Marcus Barnett, MD
Phone: 828-213-5671
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Principal Investigator: Michael Mont, MD
Phone: 410-601-8609
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Baltimore, MD
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Danville, Pennsylvania 17822
Principal Investigator: Thomas Bowen, MD
Phone: 570-271-5555
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Danville, PA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Samuel Wellman, MD
Phone: 919-668-4373
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Egg Harbor Township, New Jersey 08234
Principal Investigator: Fabio Orozco, M.D.
Phone: 609-677-7015
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Egg Harbor Township, NJ
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Gilbert, Arizona 85234
Principal Investigator: Kipling Sharpe, MD
Phone: 602-318-5716
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Gilbert, AZ
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Jacksonville, Florida 32204
Principal Investigator: R. David Heekin, MD
Phone: 904-328-5979
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Jacksonville, FL
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Lake Charles, Louisiana 70601
Principal Investigator: John Noble, MD
Phone: 337-312-8405
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Lake Charles, LA
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Tucson, Arizona 85713
Principal Investigator: Russell Cohen, M.D.
Phone: 520-784-6141
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Tucson, AZ
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Ypsilanti, Michigan 48197
Principal Investigator: Michael Masini, MD
Phone: 734-712-8087
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Ypsilanti, MI
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