- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03432481
Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS)
August 23, 2023 updated by: Laboratoires Bodycad Inc.
Open-Label Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS) in Human Subjects With Medial Unicompartmental Knee Osteoarthritis
This study is designed to observe clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis of the medial condyle.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Geoffroy Rivet-Sabourin, PhD
- Phone Number: 418-527-1388
- Email: geoffroy@bodycad.com
Study Contact Backup
- Name: Marc Chaunet
- Phone Number: 418-527-1388
- Email: mchaunet@bodycad.com
Study Locations
-
-
-
Quebec, Canada, G1J1Z4
- CHU de Québec - Université Laval
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
43 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Knee Arthroplasty using BUKS
Unicompartmental Knee Arthroplasty Surgery
|
Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)
Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Knee Society Score (KSS) Objective
Time Frame: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60
|
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)
Time Frame: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in mechanical axis measurement.
Time Frame: Baseline and post operative week 1
|
Determine by radiographic analysis Varus or Valgus, expected value are +/- 3 degrees
|
Baseline and post operative week 1
|
Change from baseline of implant position fixation
Time Frame: Post operative week 6, months 6, 12, 24, 36, 48 and 60
|
The anteroposterior and medial lateral slop will be evaluated according to initial planed position.
The measured angles will be compared with initial planning.
The expected values are +/- 1.5 degree.
|
Post operative week 6, months 6, 12, 24, 36, 48 and 60
|
Change from baseline on bone loss and cementation
Time Frame: Post operative week 6, months 6, 12, 24, 36, 48 and 60
|
Those measurements will be done on x-ray of the patient joint following Knee Society Radiological evaluation form.The tibial component acceptable score for this device will be 2.5 mm.
The femoral component acceptable score for this device will be 6 mm.
|
Post operative week 6, months 6, 12, 24, 36, 48 and 60
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Etienne Belzile, MD, CHU de Quebec - Hopital de l'Enfant-Jésus
- Study Chair: Brian Hamlin, MD, Renaissance Orthopedics
- Study Director: Geoffroy Rivet-Sabourin, PhD, Laboratoires Bodycad Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2018
Primary Completion (Actual)
August 20, 2020
Study Completion (Actual)
March 7, 2023
Study Registration Dates
First Submitted
January 22, 2018
First Submitted That Met QC Criteria
February 7, 2018
First Posted (Actual)
February 14, 2018
Study Record Updates
Last Update Posted (Actual)
August 25, 2023
Last Update Submitted That Met QC Criteria
August 23, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO-PB001-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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