Functional Impact at 12 Months Post-op of Posterior Cruciate Ligament Conservation During Robotic-assisted Surgery (MAKO) for Total Knee Replacement.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Total knee arthroplasty

    Procedure/Surgery

    Robot-assisted total knee arthroplasty

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: LCP+ groupExperimental treatment 1 intervention
Group B: LCP- groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
12 months post-surgery
2

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).

Time frame
12 months post-surgery

Secondary outcomes

1

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).

Time frame
4.5 months post-surgery
2

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).

Time frame
4.5 months post-surgery
3

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).

Time frame
4.5 months post-surgery
4

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).

Time frame
12 months post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Nīmes

Lead sponsor

Clinique Tivoli Ducos

Collaborator

Hôpital de la Croix-Rousse

Collaborator