Bicruciate-retaining vs Posterior-stabilized Knee Replacement for Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Morbid obesity, Pregnancy, Illiteracy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

77 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Bicruciate-retaining Total Knee Arthroplasty and Posterior-stabilized Total Knee Arthroplasty for osteoarthritis?

Research comparing different types of knee replacements, like posterior-stabilized and cruciate-retaining, shows mixed results in terms of knee function and complications. However, these studies suggest that both types of knee replacements can be effective, with differences in outcomes like knee movement and stability. ^{1 2 3 4 5}

Is the bicruciate-retaining or posterior-stabilized knee replacement safe for humans?

Both bicruciate-retaining and posterior-stabilized knee replacements have been used in clinical trials and studies without any specific safety issues directly linked to their design, suggesting they are generally safe for humans. ^{6 7 8 9 10}

How does bicruciate-retaining total knee arthroplasty differ from other treatments for osteoarthritis?

Bicruciate-retaining total knee arthroplasty is unique because it aims to preserve both the anterior and posterior cruciate ligaments in the knee, potentially offering a more natural knee movement compared to posterior-stabilized knee replacements, which substitute these ligaments with a mechanical component. ^{1 2 8 11 12}

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

Research Team

Frédéric Lavoie, MD, M.Sc

Principal Investigator

CHUM

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.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

1-2 weeks

Surgery and Initial Recovery

Patients undergo total knee arthroplasty surgery with either BCR or PS prosthesis. Initial recovery and monitoring post-surgery.

6 weeks

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.

10 years

Treatment Details

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.

Participant Groups

Group I: bicruciate-retaining total knee arthroplasty Experimental Treatment 1 Intervention

The prosthesis is minimally constrained and allows the preservation of both cruciate ligaments. All implants are cemented.

Group II: posterior-stabilized total knee arthroplasty Active Control 1 Intervention

The prosthesis requires the excision of both cruciate ligaments

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

References

1. France pubmed.ncbi.nlm.nih.gov

Posterior-stabilized versus cruciate-retained implants for total knee arthroplasty: a meta-analysis of clinical trials. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Posterior Cruciate Ligament Retention versus Posterior Stabilization for Total Knee Arthroplasty: A Meta-Analysis. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Posterior-Stabilized Versus Cruciate-Retaining Prostheses for Total Knee Arthroplasty: An Overview of Systematic Reviews and Risk of Bias Considerations. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Posterior cruciate-retaining versus posterior stabilized total knee arthroplasty: a meta-analysis of randomized controlled trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Midterm Outcomes of a Bicruciate-Retaining Compared With the Bicruciate-Sacrificing Knee System. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Posterior Cruciate-Retaining vs Posterior Cruciate-Stabilized Prosthesis in Total Knee Arthroplasty: A Meta-Analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Total Knee Arthroplasty Using Bicruciate-Stabilized or Posterior-Stabilized Knee Implants Provided Comparable Outcomes at 2 Years: A Prospective, Multicenter, Randomized, Controlled, Clinical Trial of Patient Outcomes. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Posterior stabilized knee arthroplasty. Six years' experience. [2016]

9. Germany pubmed.ncbi.nlm.nih.gov

Bicruciate-retaining total knee arthroplasty non-inferior to posterior-stabilized prostheses after 5 years: a randomized, controlled trial. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Preservation of kinematics with posterior cruciate-, bicruciate- and patient-specific bicruciate-retaining prostheses in total knee arthroplasty by using computational simulation with normal knee model. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Differences in outcome after cruciate retaining and posterior stabilized total knee arthroplasty. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Fixed-bearing cruciate-retaining total knee arthroplasty. [2019]