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Clinical Trials in Canada / NCT05469776
Active, not recruiting Not applicable

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

NCT05469776 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2011-01-01
Last updated
2024-08-23

Condition(s) studied

Total Knee ArthroplastyKnee Osteoarthritis

Investigational drug(s) / intervention(s)

bicruciate-retaining total knee arthroplastyposterior-stabilized total knee arthroplasty

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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 * Intact and functional cruciate ligaments * Coronal knee malalignment of 10 degrees or less * Adequate preoperative range of motion, defined as maximum flexum (inability to fully extend the knee) of 10 degrees and flexion greater than 90 degrees * Adequate intraoperative knee exposure to allow preservation of both cruciate ligaments 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 * Illiteracy, language barrier and any other reason that prevents patients from answering the questionnaires

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier de l'Université de Montréal Montreal Quebec

More Centre hospitalier de l'Université de Montréal (CHUM) trials in Canada

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05469776 on ClinicalTrials.gov ↗ ← All trials in Canada