NCT05469776

Bicruciate-retaining (2C) Total Knee Arthroplasty (TKA) Versus Posterior-stabilized (PS) Total Knee Arthroplasty (TKA)

Retention of Both Cruciate Ligaments During Total Knee Arthroplasty: a Prospective Randomized Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Posterior cruciate ligament replacement knee prostheses or posterior-stabilized (PS) are the most used type of prosthesis. Various studies of the kinematics of the prosthetic knee tend to show that implants that preserve both cruciate ligaments best reproduce the kinematics of the healthy knee. These implants are the unicondylar knee Arthroplasty - in which only one side of the femorotibial joint is replaced; most often the medial side - and the bicruciate-retaining total knee arthroplasty (BCR). The BCR prosthesis is perceived as technically difficult to install and has never been a great commercial success despite the scientific demonstration of its virtues for knee kinematics. Given the current trend among prosthetic implant manufacturers to optimize the performance of knee prostheses for younger, active patients, the retention of both cruciate ligaments appears to be an interesting alternative. Unfortunately, there are no good studies comparing the results of the BCR prosthesis to the PS prosthesis. The goal is to compare the clinical and radiological results in patients undergoing total knee replacement surgery according to the type of prosthesis used (BCR vs PS). The hypothesis is that the BCR prosthesis will result in better function of the operated knee than the PS prosthesis, resulting in joint kinematics closer to a healthy knee, better clinical scores and a higher activity level. 60 patients undergoing a total knee arthroplasty will be recruited. Randomization will be done intraoperatively using sealed envelopes once the indication for BCR TKA has been definitively established. Demographic data, medical history, clinical assessment and 4 questionnaires (IKS, KOOS, Marx and SF-12) will be completed prior to surgery. A standard x-ray, EOS imaging, TELOS radiological laximetry and a non-invasive evaluation of the 3D kinematics will be performed before the surgery. Patients will complete the 4 questionnaires at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post-surgery. A standard radiological examination will be performed at the same follow-ups. TELOS radiological laximetry, EOS imaging and 3D kinematics assessment will be repeated at the 1-year follow-up post-surgery.

Conditions

• Total Knee Arthroplasty
• Knee Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	bicruciate-retaining total knee arthroplasty
PROCEDURE	posterior-stabilized total knee arthroplasty

Timeline

• Start date: 2011-01-01
• Primary completion: 2031-12-31
• Completion: 2031-12-31
• First posted: 2022-07-22
• Last updated: 2024-08-23

Locations

1 site across 1 country: Canada