Bicruciate-retaining vs Posterior-stabilized Knee Replacement for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two types of knee replacement surgeries for individuals with severe knee osteoarthritis. One surgery uses a bicruciate-retaining prosthesis, preserving both cruciate ligaments, while the other employs a posterior-stabilized prosthesis, which removes these ligaments. Researchers aim to determine if preserving the ligaments leads to better knee function. Suitable candidates have severe knee arthritis unresponsive to other treatments, intact cruciate ligaments, and a knee extension limitation of only 10 degrees. As an unphased trial, this study provides patients the chance to contribute to valuable research that could enhance future knee replacement options.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both bicruciate-retaining total knee arthroplasty (TKA) and posterior-stabilized TKA are generally safe options for knee replacement. In bicruciate-retaining TKA, studies indicate that 85.7% of patients did not need further surgery after about 8 years. Some complications include tibial loosening (3.9%) and stiffness (2.4%), leading a small number of patients to require additional surgery.
For posterior-stabilized TKA, research demonstrates a high rate of implant success. After fifteen years, implant survival rates were about 91% and 92% in different groups, indicating long-lasting performance. The need for further surgery is low, with only 3.7% of patients requiring it after five years.
Both treatments perform well over the long term with some minor risks. These findings suggest that both types of knee replacements are generally well-tolerated by patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for knee osteoarthritis because they offer new approaches to knee replacement surgery. The bicruciate-retaining total knee arthroplasty is distinctive because it preserves both cruciate ligaments, which can help maintain more natural knee function and movement. This is different from the posterior-stabilized option, which requires removing both cruciate ligaments to stabilize the knee. By preserving these ligaments, the bicruciate-retaining approach could potentially result in a more natural feeling knee post-surgery, which is a major goal for improving patient outcomes.
What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?
This trial will compare two types of knee replacements: bicruciate-retaining total knee arthroplasty (BCR TKA) and posterior-stabilized total knee arthroplasty (PS TKA). Research has shown that BCR TKA, which preserves both knee ligaments, can enhance knee function. Specifically, one study found that BCR TKA improved walking ability more than other knee implants, with a reported 98.4% survival rate, indicating long-lasting implants. In contrast, PS TKA significantly reduces pain and improves knee movement, particularly in older patients, with about 80-85% of patients reporting satisfaction after surgery. Both types of knee replacements are effective, but they may work differently for different individuals.14678
Who Is on the Research Team?
Frédéric Lavoie, MD, M.Sc
Principal Investigator
CHUM
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Assessment
Demographic data, medical history, clinical assessment, and 4 questionnaires (IKS, KOOS, Marx, and SF-12) are completed. Standard x-ray, EOS imaging, TELOS radiological laximetry, and 3D kinematics evaluation are performed.
Surgery and Initial Recovery
Patients undergo total knee arthroplasty surgery with either BCR or PS prosthesis. Initial recovery and monitoring post-surgery.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up assessments include questionnaires and radiological examinations at 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years post-surgery.
What Are the Treatments Tested in This Trial?
Interventions
- Bicruciate-retaining Total Knee Arthroplasty
- Posterior-stabilized Total Knee Arthroplasty
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The prosthesis is minimally constrained and allows the preservation of both cruciate ligaments. All implants are cemented.
The prosthesis requires the excision of both cruciate ligaments
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Citations
Bicruciate-retaining total knee arthroplasty: What's new? - PMC
A case-control study designed by Kalaai et al[33] displayed a survival rate of 98.4% for both the CR and BCR TKA groups; one revision in the BCR group was ...
Comparison of clinical outcomes among total knee ...
BCR TKA retains the PCL as well as the ACL. A recent study showed that BCR TKA had similar functional and radiographic outcomes compared to CR ...
Robotic-Assisted Total Knee Arthroplasty: Cruciate ...
The Bi-Cruciate Retaining (BCR) total knee arthroplasty was designed for more kinematically functional implants that better reconstruct natural knee kinematics ...
Anatomical bi-cruciate retaining TKA improves gait ability ...
Based on triaxial accelerometery data, BCR TKA improved gait ability (walking time, number of steps, velocity, and stride length) more than BCS TKA at 6 weeks ...
Cruciate-Retaining Implants Do Not Provide a More ...
Results: Seventeen cohort studies involving 4,245 patients were included. The meta-analysis demonstrated that CS implants were superior to CR ...
Complications of Bicruciate-Retaining Total Knee Arthroplasty
Revision-free survival at 100 months was 85.7%. Revision was performed for aseptic tibial loosening in eight knees (3.9%) and stiffness in five knees (2.4%).
Comparative efficacy and safety of bicompartmental versus ...
The results of the analysis revealed that BKA yielded better postoperative outcomes than TKA, in terms of Knee Society Score (KSS) Knee Score, ...
Bicruciate-Retaining Total Knee Arthroplasty: State of the ...
The authors reported on the survival of 21 cemented and 25 cementless BCR-TKAs. In the cemented group, 12-year overall survival was 90.9%, and in the cementless ...
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