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Procedure

Bicruciate-retaining vs Posterior-stabilized Knee Replacement for Osteoarthritis

N/A
Waitlist Available
Led By Frédéric Lavoie, MD, M.Sc
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline (pre surgery) marx score at 10 yearss after the surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the clinical and radiological results of 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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, typical risks include pain at the surgery site, infection, blood clots or deep vein thrombosis (DVT), stiffness or difficulty moving the joint as expected after surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (pre surgery) marx score at 10 yearss after the surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (pre surgery) marx score at 10 yearss after the surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in 12-Item Short Form Survey (SF-12) score
Change in EOS imaging pseudo-kinematic - free squatting task - knee abduction and adduction
Change in EOS imaging pseudo-kinematic - free squatting task - knee flexion and extension
+27 more
Other study objectives
Change in Body Mass Index (BMI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,303 Total Patients Enrolled
4 Trials studying Osteoarthritis
481 Patients Enrolled for Osteoarthritis
Frédéric Lavoie, MD, M.ScPrincipal InvestigatorCHUM

Media Library

Bicruciate-retaining Total Knee Arthroplasty (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05469776 — N/A
Osteoarthritis Research Study Groups: posterior-stabilized total knee arthroplasty, bicruciate-retaining total knee arthroplasty
Osteoarthritis Clinical Trial 2023: Bicruciate-retaining Total Knee Arthroplasty Highlights & Side Effects. Trial Name: NCT05469776 — N/A
Bicruciate-retaining Total Knee Arthroplasty (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05469776 — N/A
~26 spots leftby Dec 2031
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