رادار التجارب السريرية

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).

12 months post-surgery

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).

12 months post-surgery

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).

4.5 months post-surgery

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).

4.5 months post-surgery

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).

4.5 months post-surgery

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).

12 months post-surgery

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).

4.5 months post-surgery

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).

12 months post-surgery

KSS (Knee Society Score) in the LCP+ group

The KSS questionnaire includes a Knee Score, rating the knee joint itself (pain, range of motion, stability and radiographic alignment), and a Function Score (patient's walking distance, climbing stairs and use of walking aids).The Knee Score allocates a maximum of 100 points to evaluate range of motion (1 point per 5°, maximum 125°), stability (medial/lateral (15 points) and anterior/posterior (10 points)) and pain (50 points) with deductions for extension lag, flexion contracture and malalignment (if leg axis \< 5 or \> 10° on radiological examination). A maximum score of 100 points is a well-aligned knee with 125° of motion, almost none anteroposterior or mediolateral instability and no pain. The Function Score considers walking distance (50 points) and stair-climbing (50 points) with deduction if a walking aid is used. A patient who walks unlimited and has no trouble climbing stairs gets the maximum Function Score of 100 points.

4.5 months post-surgery

KSS (Knee Society Score) in the LCP+ group

The KSS questionnaire includes a Knee Score, rating the knee joint itself (pain, range of motion, stability and radiographic alignment), and a Function Score (patient's walking distance, climbing stairs and use of walking aids).The Knee Score allocates a maximum of 100 points to evaluate range of motion (1 point per 5°, maximum 125°), stability (medial/lateral (15 points) and anterior/posterior (10 points)) and pain (50 points) with deductions for extension lag, flexion contracture and malalignment (if leg axis \< 5 or \> 10° on radiological examination). A maximum score of 100 points is a well-aligned knee with 125° of motion, almost none anteroposterior or mediolateral instability and no pain. The Function Score considers walking distance (50 points) and stair-climbing (50 points) with deduction if a walking aid is used. A patient who walks unlimited and has no trouble climbing stairs gets the maximum Function Score of 100 points.

12 months post-surgery

KSS (Knee Society Score) in the LCP- group

The KSS questionnaire includes a Knee Score, rating the knee joint itself (pain, range of motion, stability and radiographic alignment), and a Function Score (patient's walking distance, climbing stairs and use of walking aids).The Knee Score allocates a maximum of 100 points to evaluate range of motion (1 point per 5°, maximum 125°), stability (medial/lateral (15 points) and anterior/posterior (10 points)) and pain (50 points) with deductions for extension lag, flexion contracture and malalignment (if leg axis \< 5 or \> 10° on radiological examination). A maximum score of 100 points is a well-aligned knee with 125° of motion, almost none anteroposterior or mediolateral instability and no pain. The Function Score considers walking distance (50 points) and stair-climbing (50 points) with deduction if a walking aid is used. A patient who walks unlimited and has no trouble climbing stairs gets the maximum Function Score of 100 points.

4.5 months post-surgery

KSS (Knee Society Score) in the LCP- group

The KSS questionnaire includes a Knee Score, rating the knee joint itself (pain, range of motion, stability and radiographic alignment), and a Function Score (patient's walking distance, climbing stairs and use of walking aids).The Knee Score allocates a maximum of 100 points to evaluate range of motion (1 point per 5°, maximum 125°), stability (medial/lateral (15 points) and anterior/posterior (10 points)) and pain (50 points) with deductions for extension lag, flexion contracture and malalignment (if leg axis \< 5 or \> 10° on radiological examination). A maximum score of 100 points is a well-aligned knee with 125° of motion, almost none anteroposterior or mediolateral instability and no pain. The Function Score considers walking distance (50 points) and stair-climbing (50 points) with deduction if a walking aid is used. A patient who walks unlimited and has no trouble climbing stairs gets the maximum Function Score of 100 points.

12 months post-surgery

Radiological posterior laxity in the LCP+ group

Qualitative. Radiological examination as part of standard treatment.

4.5 months post-surgery

Radiological posterior laxity in the LCP+ group

Qualitative. Radiological examination as part of standard treatment.

12 months post-surgery

Radiological posterior laxity in the LCP- group

Qualitative. Radiological examination as part of standard treatment.

4.5 months post-surgery

Radiological posterior laxity in the LCP- group

Qualitative. Radiological examination as part of standard treatment.

12 months post-surgery

Cost to the community of the care pathway associated with rehabilitation in the LCP+ group

Quantitative, in Euros per patient.

Up to 12 months after surgery

Cost to the community of the care pathway associated with rehabilitation in the LCP- group

Quantitative, in Euros per patient.

Up to 12 months after surgery

Sustainability of the annual planned budget if using the strategy under evaluation, nationwide, from the health insurance's point of view

Cost to the French health insurance system of adopting the technique of robotic knee arthroplasty with conservation of the posterior cruciate ligament

Up to 12 months after surgery