Triathlon® Partial Knee Replacement (PKR) Outcomes Study



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA), Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:21 - 75
Updated:11/1/2018
Start Date:January 2010
End Date:January 2029
Contact:Lorie Gardner
Email:Lorie.Gardner@stryker.com
Phone:201-831-5491

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A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Partial Knee Resurfacing (PKR) Unicondylar Knee System

The purpose of the study is to evaluate the Triathlon® PKR Knee System and determine whether
or not the success rate of this device is no worse than the reported success rate of similar
devices.


Inclusion Criteria:

- The subject is a male or non-pregnant female 21-75 years of age at the time of
enrollment.

- The subject requires a primary cemented unicompartmental knee replacement.

- The subject has a diagnosis of osteoarthritis (OA) or posttraumatic arthritis (TA).

- The subject has clinically intact cruciate and collateral ligaments and no ligamentous
instability is present.

- The subject has less than 10 degrees of flexion contracture and greater than 90
degrees of flexion.

- The subject's preoperative mechanical alignment is less than 10 degrees of varus and
10 degrees of valgus.

- The subject has signed the IRB approved study specific Informed Patient Consent Form.

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

Exclusion Criteria:

- The subject has inflammatory arthritis or avascular necrosis(AVN).

- The subject is obese, BMI > 35.

- The subject has a history of total or unicompartmental (contralateral compartment
and/or patellofemoral joint) reconstruction of the affected joint.

- The subject has a history of ACL reconstruction.

- The subject has had a high distal femoral, or proximal tibial osteotomy.

- The subject has a mental, neuromuscular or neurosensory disorder, which would create
an unacceptable risk of prosthesis instability, prosthesis fixation failure, or
complications in post-operative care and/or limit the ability to assess the
performance of the device.

- The subject has a systemic or metabolic disorder leading to progressive bone
deterioration that the surgeon feels would affect the overall outcome of the study.

- The subject is immunologically suppressed, or is receiving chronic steroids (>30 days
duration).

- The subject has a known sensitivity to device materials.

- The subject's bone stock is compromised by disease and/or infection which cannot
provide adequate support and/or fixation to the prosthesis.

- The subject's bone stock is compromised by a prior implantation which cannot provide
adequate support and/or fixation to the prosthesis.

- The subject has an active or suspected latent infection in or about the knee joint.

- The subject is a prisoner.
We found this trial at
8
sites
Syracuse, New York 13214
Principal Investigator: Brett Greenky, MD
Phone: 315-883-5816
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Buffalo, New York 14203
Principal Investigator: Matthew Phillips, MD
Phone: 716-859-1253
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Buffalo, NY
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Edmond, Oklahoma 73103
Principal Investigator: Paul Jacob, MD
Phone: 405-424-5426
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Edmond, OK
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Effingham, Illinois 62401
Principal Investigator: Peter Bonutti, MD
Phone: 217-342-3400
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Effingham, IL
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Egg Harbor Township, New Jersey 08234
Principal Investigator: Fabio Orozco, MD
Phone: 609-677-7015
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Egg Harbor Township, NJ
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Jacksonville, Florida 32204
Principal Investigator: R. David Heekin, M.D.
Phone: 904-328-5979
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Jacksonville, FL
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Morrisville, Vermont 05661
Principal Investigator: Bryan Huber, MD
Phone: 802-888-8405
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Morrisville, VT
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Stollberg,
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