77 Participants Needed

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

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.12345

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.678910

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.1281112

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

FL

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
See 4 more

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
See 1 more

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
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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

References

Posterior-stabilized versus cruciate-retained implants for total knee arthroplasty: a meta-analysis of clinical trials. [2020]
Posterior Cruciate Ligament Retention versus Posterior Stabilization for Total Knee Arthroplasty: A Meta-Analysis. [2019]
Posterior-Stabilized Versus Cruciate-Retaining Prostheses for Total Knee Arthroplasty: An Overview of Systematic Reviews and Risk of Bias Considerations. [2023]
Posterior cruciate-retaining versus posterior stabilized total knee arthroplasty: a meta-analysis of randomized controlled trials. [2022]
Midterm Outcomes of a Bicruciate-Retaining Compared With the Bicruciate-Sacrificing Knee System. [2022]
Posterior Cruciate-Retaining vs Posterior Cruciate-Stabilized Prosthesis in Total Knee Arthroplasty: A Meta-Analysis. [2023]
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]
Posterior stabilized knee arthroplasty. Six years' experience. [2016]
Bicruciate-retaining total knee arthroplasty non-inferior to posterior-stabilized prostheses after 5 years: a randomized, controlled trial. [2023]
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]
Differences in outcome after cruciate retaining and posterior stabilized total knee arthroplasty. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Fixed-bearing cruciate-retaining total knee arthroplasty. [2019]
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