About this trial
Studies have been made on the best way to do knee surgery and whether to conserve the posterior cruciate ligament or not during total knee prosthesis insertion is still under debate. However, most of these studies were made before the introduction of robotic knee surgery. It seems timely to do a study comparing these two surgical techniques: preservation versus removal of the posterior cruciate ligament in knee arthroplasty
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient scheduled for first-intention robotic-assisted total knee replacement (MAKO).
Unilateral replacement, regardless of laterality.
Patient able to answer questionnaires.
Patient willing to undergo usual 12-month follow-up.
Disqualifiers
Patient with intraoperative technical impossibility of retaining PCL (flessum > 20°, flexion stiffening < 100°).
Previous posterior cruciate ligament surgery.
Post-traumatic gonarthrosis.
Valgus > 185°.
Trial design
Parallel
Treatments tested in this trial
Total knee arthroplasty
Procedure/SurgeryRobot-assisted total knee arthroplasty
Treatment groups
Trial outcomes
Primary outcomes
Functional impact at of posterior cruciate ligament preservation in the LCP+group
Evaluated according to the FJS-12 (Forgotten Joint Score) self-questionnaire. The FJS-12 is a self-administered questionnaire consisting of 12 items. The patient is asked to rate their awareness of their artificial joint for the 12 activities. Each item is then given a score of between 0-4 on a five-point Likert scale in which : 0 - Never,1 - Almost Never, 2 - Seldom, 3 - Sometimes,4 - Mostly. The answers are then summed and divided by the number of completed items. The mean value is then multiplied by 25 to obtain the total score of 0-100. The higher scores indicating better outcomes (less awareness of the joint).
Functional impact at of posterior cruciate ligament resection in the LCP-group
Evaluated according to the FJS-12 (Forgotten Joint Score) self-questionnaire. The FJS-12 is a self-administered questionnaire consisting of 12 items. The patient is asked to rate their awareness of their artificial joint for the 12 activities. Each item is then given a score of between 0-4 on a five-point Likert scale in which : 0 - Never,1 - Almost Never, 2 - Seldom, 3 - Sometimes,4 - Mostly. The answers are then summed and divided by the number of completed items. The mean value is then multiplied by 25 to obtain the total score of 0-100. The higher scores indicating better outcomes (less awareness of the joint).
Secondary outcomes
Functional impact at of posterior cruciate ligament preservation in the LCP+group
Evaluated according to the FJS-12 (Forgotten Joint Score) self-questionnaire. The FJS-12 is a self-administered questionnaire consisting of 12 items. The patient is asked to rate their awareness of their artificial joint for the 12 activities. Each item is then given a score of between 0-4 on a five-point Likert scale in which : 0 - Never,1 - Almost Never, 2 - Seldom, 3 - Sometimes,4 - Mostly. The answers are then summed and divided by the number of completed items. The mean value is then multiplied by 25 to obtain the total score of 0-100. The higher scores indicating better outcomes (less awareness of the joint).
Functional impact at of posterior cruciate ligament ablation in the LCP-group
Evaluated according to the FJS-12 (Forgotten Joint Score) self-questionnaire. The FJS-12 is a self-administered questionnaire consisting of 12 items. The patient is asked to rate their awareness of their artificial joint for the 12 activities. Each item is then given a score of between 0-4 on a five-point Likert scale in which : 0 - Never,1 - Almost Never, 2 - Seldom, 3 - Sometimes,4 - Mostly. The answers are then summed and divided by the number of completed items. The mean value is then multiplied by 25 to obtain the total score of 0-100. The higher scores indicating better outcomes (less awareness of the joint).
Algo-functional OKS (Oxford Knee Score) in the LCP+group
The OKS is a patient-reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks. It uses a scoring system from 0-4 where four is the best outcome and total scores range from 0 (poorest function) to 48 (maximal function).
Algo-functional OKS (Oxford Knee Score) in the LCP+group
The OKS is a patient-reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks. It uses a scoring system from 0-4 where four is the best outcome and total scores range from 0 (poorest function) to 48 (maximal function).
Sponsors and contacts
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Centre Hospitalier Universitaire de Nīmes
Lead sponsor
Clinique Tivoli Ducos
Collaborator
Hôpital de la Croix-Rousse
Collaborator