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 |
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.
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
Effingham, Illinois 62401
Principal Investigator: Peter Bonutti, MD
Phone: 217-342-3400
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Buffalo, New York 14203
Principal Investigator: Matthew Phillips, MD
Phone: 716-859-1253
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Edmond, Oklahoma 73103
Principal Investigator: Paul Jacob, MD
Phone: 405-424-5426
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Egg Harbor Township, New Jersey 08234
Principal Investigator: Fabio Orozco, MD
Phone: 609-677-7015
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Jacksonville, Florida 32204
Principal Investigator: R. David Heekin, M.D.
Phone: 904-328-5979
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Morrisville, Vermont 05661
Principal Investigator: Bryan Huber, MD
Phone: 802-888-8405
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Syracuse, New York 13214
Principal Investigator: Brett Greenky, MD
Phone: 315-883-5816
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