TerminatedNot Applicable

Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS)

Stopped: interruption due to the ongoing corporate restructuring, which has resulted in the cessation of our interest in pursuing any clinical activities related to the product.

Canada28 participantsStarted 2018-01-24

Plain-language summary

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

Who can participate

Age range

45 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in Knee Society Score (KSS) Objective

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

Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)

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

Trial details

NCT IDNCT03432481

SponsorLaboratoires Bodycad Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08-20

View on ClinicalTrials.gov More Osteoarthritis, Knee trials