Clinical trial NCT03432481: Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS)
Official title: Open-Label Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS) in Human Subjects With Medial Unicompartmental Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee
Lead sponsor: Laboratoires Bodycad Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 28
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group
Primary purpose: TREATMENT

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 patient-specific knee replacement prosthesis will provide a greater stability and a more natural knee motion in addition to a faster recovery when compared to traditional knee replacement systems. This study is designed to provide a five-years follow-up clinical data on safety and effectiveness of the device.

Eligibility criteria: Inclusion Criteria:

1. 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);
2. Between the ages of at least 45 years and 70 years (inclusive) at the time of enrollment;
3. Stable health as judged by the Investigator;
4. Willingness to adhere to the protocol requirements as evidenced by the informed consent form duly read, signed and dated by the subject.

Exclusion Criteria:

1. Presence of active or latent infection in the knee;
2. Diagnosis of rheumatoid arthritis or avascular necrosis;
3. Presence of moderate patellofemoral osteoarthritic disease or patellofemoral maltracking;
4. Anterior or posterior translational, varus or valgus ligamentous knee instability and/or deformity;
5. Extension deficit \> 15˚ of affected knee;
6. 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;
7. History of proximal tibial fracture, non-union, deformity or oblique joint line;
8. Deficient bone mass that may not provide adequate support and / or fixation;
9. Skeletal immaturity;
10. Obesity: BMI above 35
11. 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;
12. Known sensitivity to CoCrMo, Titanium, and polyethylene components of the UKS Prosthesis used in the manufacturing of the prosthesis;
13. 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;
14. Neuromuscular condition that could lead to an unacceptable risk of instability of the prosthesis or other postoperative complications;
15. 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);
16. Pregnant or nursing female subjects; or female subjects planning on becoming pregnant within the next 60 months from enrollment;
17. Subjects under guardianship, hospitalized in a public or private institution, for a reason other than research, or subject deprived of freedom;
18. Participation in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.

Primary outcomes:
measure: Change from baseline in Knee Society Score (KSS) Objective
timeFrame: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60
measure: Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60
Secondary outcomes:
measure: Change from baseline in mechanical axis measurement.
timeFrame: Baseline and post operative week 1
measure: Change from baseline of implant position fixation
timeFrame: Post operative week 6, months 6, 12, 24, 36, 48 and 60
measure: Change from baseline on bone loss and cementation
timeFrame: Post operative week 6, months 6, 12, 24, 36, 48 and 60
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: CHU de Quebec - Universite Laval
Study officials:
affiliation: CHU de Quebec - Hopital de l'Enfant-Jésus
name: Etienne Belzile, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Renaissance Orthopedics
name: Brian Hamlin, MD
role: STUDY_CHAIR
affiliation: Laboratoires Bodycad Inc.
name: Geoffroy Rivet-Sabourin, PhD
role: STUDY_DIRECTOR
References: