~25 spots leftby Dec 2031

Bicruciate-retaining vs Posterior-stabilized Knee Replacement for Osteoarthritis

Recruiting in Palo Alto (17 mi)
Overseen ByFrédéric Lavoie, MD, M.Sc
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
No Placebo Group

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

This trial is for people under 70 with severe knee osteoarthritis needing a total knee replacement, who have failed conservative treatments. They must be able to fully extend the knee within 10 degrees and bend it past 90 degrees, have intact cruciate ligaments, less than 10 degrees of knee malalignment, and be capable of undergoing an EOS exam.

Participant Groups

The study compares two types of total knee replacements: bicruciate-retaining (2C) that keeps both cruciate ligaments versus posterior-stabilized (PS), which does not. It's a randomized controlled trial where patients are assigned by chance using sealed envelopes to determine if one results in better function.
2Treatment groups
Experimental Treatment
Active Control
Group I: bicruciate-retaining total knee arthroplastyExperimental Treatment1 Intervention
The prosthesis is minimally constrained and allows the preservation of both cruciate ligaments. All implants are cemented.
Group II: posterior-stabilized total knee arthroplastyActive Control1 Intervention
The prosthesis requires the excision of both cruciate ligaments

Find A Clinic Near You

Research locations nearbySelect from list below to view details:
Centre Hospitalier de l'Université de MontréalMontréal, Canada
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Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

References