Triathlon Tritanium Cone Augments Outcomes Study



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:August 2015
End Date:July 2028
Contact:Alice Cruz
Email:alice.cruz@stryker.com
Phone:201-831-5859

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A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon TS Total Knee System With Triathlon Tritanium Cone Augments

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical
evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for
revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the
eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected
to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments
at 2 years postoperative.


Inclusion Criteria:

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

- Patient is a male or non-pregnant female, skeletally mature and age 18 years or older
at time of study device implantation.

- Patient is a candidate for revision of all femoral and tibial components of a total
knee replacement.

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

Exclusion Criteria:

- Patient has a Body Mass Index (BMI) > 45.

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

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

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

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

- Patient has a failed unicondylar knee prosthesis.

- Patient has a known sensitivity to device materials.

- Patient is a prisoner.
We found this trial at
10
sites
Tulsa, Oklahoma 74120
Principal Investigator: Yogesh Mittal, MD
Phone: 918-582-6800
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Tulsa, OK
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Craig Della Valle, MD
Phone: 312-432-2418
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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1100 Virginia Avenue
Columbia, Missouri 65212
Principal Investigator: Ajay Aggarwal, MD
Phone: 573-884-4565
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Columbia, MO
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Egg Harbor Township, New Jersey 08234
Principal Investigator: Fabio Orozco, MD
Phone: 609-407-6446
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Egg Harbor Township, NJ
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Galveston, Texas 77555
Principal Investigator: Louis S. Stryker, MD
Phone: 409-747-3221
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Galveston, TX
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Novi, Michigan 48374
Principal Investigator: David Markel, MD
Phone: 248-485-7025
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Novi, MI
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Sarasota, Florida 34232
Principal Investigator: Edward Stolarski, MD
Phone: 941-552-7875
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Sarasota, FL
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Spokane, Washington 99204
Principal Investigator: Joshua Drumm, DO
Phone: 509-474-3829
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Spokane, WA
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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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Zephyrhills, Florida 33542
Principal Investigator: Gerald E Alexander III, MD
Phone: 813-979-0440
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Zephyrhills, FL
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