Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS)
Stopped: interruption due to the ongoing corporate restructuring, which has resulted in the cessation of our interest in
pursuing any clinical activities related to the product.
Canada28 participantsStarted 2018-01-24
Plain-language summary
This study is designed to observe clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis of the medial condyle.
Who can participate
Age range45 Years – 70 Years
SexALL
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Inclusion criteria
✓. Medial unicompartmental knee osteoarthritic disease diagnosed on the basis of the American College of Rheumatology criterion with radiographic confirmation (Kellgren- Lawrence grade 3 or higher, on a scale of 0 to 4, with higher numbers indicating more severe signs of osteoarthritis); or isolated medial compartment post-traumatic arthritis supported by long film (x-ray);
✓. Between the ages of at least 45 years and 70 years (inclusive) at the time of enrollment;
✓. Stable health as judged by the Investigator;
✓. Willingness to adhere to the protocol requirements as evidenced by the informed consent form duly read, signed and dated by the subject.
Exclusion criteria
✕. Presence of active or latent infection in the knee;
✕. Diagnosis of rheumatoid arthritis or avascular necrosis;
✕. Presence of moderate patellofemoral osteoarthritic disease or patellofemoral maltracking;
✕. Anterior or posterior translational, varus or valgus ligamentous knee instability and/or deformity;
✕. Extension deficit \> 15˚ of affected knee;
✕. History of ligament surgery on the affected knee, patient that already have a prosthesis on other condyles of the affected knee and/or patient requiring a revision knee replacement surgery;
✕. History of proximal tibial fracture, non-union, deformity or oblique joint line;
What they're measuring
1
Change from baseline in Knee Society Score (KSS) Objective