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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
      • Quebec, Canada, G1J1Z4
        • CHU de Quebec - Universite 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Knee Arthroplasty using BUKS
Unicompartmental Knee Arthroplasty Surgery
Procedure: Unicompartmental Knee Arthroplasty Surgery
Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)
Device: Bodycad Unicompartmental Knee System (BUKS)
Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laboratoires Bodycad Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Etienne Belzile, MD, CHU de Quebec - Hopital de l'Enfant-Jesus
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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