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 |
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.
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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1653 W. Congress Parkway
Chicago, Illinois 60612
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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1100 Virginia Avenue
Columbia, Missouri 65212
Columbia, Missouri 65212
Principal Investigator: Ajay Aggarwal, MD
Phone: 573-884-4565
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Egg Harbor Township, New Jersey 08234
Principal Investigator: Fabio Orozco, MD
Phone: 609-407-6446
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Galveston, Texas 77555
Principal Investigator: Louis S. Stryker, MD
Phone: 409-747-3221
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Novi, Michigan 48374
Principal Investigator: David Markel, MD
Phone: 248-485-7025
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Sarasota, Florida 34232
Principal Investigator: Edward Stolarski, MD
Phone: 941-552-7875
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Spokane, Washington 99204
Principal Investigator: Joshua Drumm, DO
Phone: 509-474-3829
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Ypsilanti, Michigan 48197
Principal Investigator: Michael Masini, MD
Phone: 734-712-8087
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Zephyrhills, Florida 33542
Principal Investigator: Gerald E Alexander III, MD
Phone: 813-979-0440
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