Triathlon® Partial Knee Replacement (PKR) Outcomes Study

Stopped early · Not applicable

Conditions studied: Arthroplasty, Replacement, Knee

In brief

The purpose of this study is to compare the 10-year Knee Society Score (KSS) functional results of the Triathlon PKR Unicondylar Knee to the 10-year Knee Society Score (KSS) functional results of the Triathlon Cruciate Retaining (CR) Total Knee.

Key facts

Study ID

NCT00966979

Run by

Stryker Orthopaedics

People needed

111

Starts

2010-01-01

Expected to finish

2023-05-01

Last updated by the study team

2023-09-13

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 15 degrees of varus and 15 degrees of valgus.
• The subject has signed the Institutional Review Board (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.

You may not qualify if…

• 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 anterior cruciate ligament (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.

Where it is running

• Heekin Orthopaedic Institute for Research, Inc. — Jacksonville, Florida, United States
• Rothman Institute — Egg Harbor, New Jersey, United States
• Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital — Buffalo, New York, United States
• Syracuse Orthopedic Specialists — Syracuse, New York, United States
• Rothman Institute — Media, Pennsylvania, United States
• Mansfield Orthopaedics — Morrisville, Vermont, United States
• Praxisklinik Stollberg und Arthro. Zentrum GmbH — Stollberg, Germany
• Presidlo Ospedaliero Civile Santi Antonio e Biagio — Alessandria, Italy
• Hassleholm Sygehus Ortopaedkirurgisk afd. Esplanadgatan — Hässleholm, Sweden

Full record on ClinicalTrials.gov

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