Status:
TERMINATED
Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS)
Lead Sponsor:
Laboratoires Bodycad Inc.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief Summary
This study is designed to observe clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis of the medial condyle.
Detailed Description
The patient-specific Bodycad Unicompartmental Knee System will be implanted on patients with knee osteoarthritis of the medial condyle. The study's hypothesis is that personalized shape and fit of pat...
Eligibility Criteria
Inclusion
- 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
- 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;
- Deficient bone mass that may not provide adequate support and / or fixation;
- Skeletal immaturity;
- Obesity: BMI above 35
- Risk of exposing the prosthesis to overload by the practice of contact or high impact sports such as: baseball, hockey, basketball, football, soccer, karate, skiing etc;
- Known sensitivity to CoCrMo, Titanium, and polyethylene components of the UKS Prosthesis used in the manufacturing of the prosthesis;
- Pre-existing medical conditions such as history of cancer other than skin cancer, poorly controlled diabetes, systemic infections, immunocompromised, fibromyalgia or other general body pain conditions, which, in the opinion of the Investigator, interfere with the conduct of the study;
- Neuromuscular condition that could lead to an unacceptable risk of instability of the prosthesis or other postoperative complications;
- Subjects, in the opinion of the Investigator, who are unlikely to comply with the protocol (e.g. active alcoholism, drug dependency or psychotic state, unable or unwilling to adhere to study visit schedule);
- Pregnant or nursing female subjects; or female subjects planning on becoming pregnant within the next 60 months from enrollment;
- Subjects under guardianship, hospitalized in a public or private institution, for a reason other than research, or subject deprived of freedom;
- Participation in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03432481
Start Date
January 24 2018
End Date
March 7 2023
Last Update
August 25 2023
Active Locations (1)
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1
CHU de Quebec - Universite Laval
Québec, Canada, G1J1Z4