Bicruciate-retaining (2C) Total Knee Arthroplasty (TKA) Versus Posterior-stabilized (PS) Total Kn… (NCT05469776) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Bicruciate-retaining (2C) Total Knee Arthroplasty (TKA) Versus Posterior-stabilized (PS) Total Knee Arthroplasty (TKA)
Canada77 participantsStarted 2011-01-01
Plain-language summary
Total knee arthroplasty (TKA) with the sacrifice of the anterior cruciate ligament is the standard treatment for severe knee osteoarthritis. A number of studies on the kinematics of the prosthetic knee tend to show that implants that preserve the cruciate ligaments best reproduce the kinematics of the healthy knee. The goal is to compare the clinical and radiological results in patients undergoing total knee replacement surgery according to the type of prosthesis used. It is anticipated that the bicruciate-retaining prosthesis will result in better function of the operated knee than the posterior-stabilized prosthesis.
Method:
* Randomized controlled trial
* Monocentric
* Randomization will be done using sealed envelopes
Who can participate
Age range
18 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:
* Patients awaiting a total knee replacement who are candidates for a bi-cruciate retaining prosthesis
* Disabling bicompartmental gonarthrosis with failure of conservative treatment
* 70 years of age or younger at the time of the pre-operative consultation
* Intact and functional cruciate ligaments
* Coronal knee malalignment of 10 degrees or less
* Adequate preoperative range of motion, defined as maximum flexum (inability to fully extend the knee) of 10 degrees and flexion greater than 90 degrees
* Adequate intraoperative knee exposure to allow preservation of both cruciate ligaments
Exclusion Criteria:
* Inability to undergo an EOS examination, defined as the inability to stand or morbid obesity (inability of the patient to enter the EOS machine, which is relatively cramped)
* Inability to walk on a treadmill and squat
* Pregnant women to avoid unnecessary fetal radiation
* Illiteracy, language barrier and any other reason that prevents patients from answering the questionnaires
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
1
Change in KOOS pain score
Timeframe: Change from baseline (pre surgery) KOOS pain score at 10 years after the surgery
Trial details
NCT IDNCT05469776
SponsorCentre hospitalier de l'Université de Montréal (CHUM)