Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS)

NCT03432481 | Terminated

• 1 other identifier: PRO-PB001-42
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to observe clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis of the medial condyle.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Knee Society Score (KSS) Objective

  Assessment of improvement of clinical outcomes following BUKS implantation using the KSS questionnaire, to evaluate the clinical performance of the articulation

  Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60

• Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)

  Assessment of improvement of activity levels following BUKS implantation surgery using the KOOS questionnaire

  Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60

Secondary Outcomes (3)

• Change from baseline in mechanical axis measurement.

  Baseline and post operative week 1

• Change from baseline of implant position fixation

  Post operative week 6, months 6, 12, 24, 36, 48 and 60

• Change from baseline on bone loss and cementation

  Post operative week 6, months 6, 12, 24, 36, 48 and 60

Study Arms (1)

Knee Arthroplasty using BUKS

EXPERIMENTAL

Unicompartmental Knee Arthroplasty Surgery

Procedure: Unicompartmental Knee Arthroplasty Surgery; Device: Bodycad Unicompartmental Knee System (BUKS)

Interventions

Unicompartmental Knee Arthroplasty Surgery PROCEDURE

Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)

Knee Arthroplasty using BUKS

Bodycad Unicompartmental Knee System (BUKS) DEVICE

Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)

Knee Arthroplasty using BUKS

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Laboratoires Bodycad Inc.: lead

Study Sites (1)

CHU de Quebec - Universite Laval

Québec, G1J1Z4, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Etienne Belzile, MD

  CHU de Quebec - Hopital de l'Enfant-Jésus

  PRINCIPAL INVESTIGATOR

• Brian Hamlin, MD

  Renaissance Orthopedics

  STUDY CHAIR

• Geoffroy Rivet-Sabourin, PhD

  Laboratoires Bodycad Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 14, 2018
• Study Start: January 24, 2018
• Primary Completion: August 20, 2020
• Study Completion: March 7, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

CA (1)