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| Name | Class |
|---|---|
| Clinique Tivoli Ducos | OTHER |
| Hôpital de la Croix-Rousse | OTHER |
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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
Knee arthroplasty is a growing surgical discipline and 102,655 prostheses were fitted in France in 2019. The principle of total knee arthroplasty (TKA) is to replace a thickness of bone and cartilage whilst maintaining homogeneous tension of the capsulo-ligamentary envelope. Different designs have been developed over the years to achieve a good compromise between stability and mobility, ligament balancing being one of the major challenges of this procedure. The results of this surgery are good, but remain inferior to those of the total hip prosthesis. Around 1/5 patients operated on are dissatisfied.
The posterior cruciate ligament (PCL) plays a role in the stability of the prosthetic knee, preventing anteroposterior translation and allowing femoral roll-back. It also plays a role in flexion space. However, whether or not the PCL is retained during total prosthetic knee insertion has not been shown to make any difference to clinical or functional outcomes.
The proprioceptive role of mechanoreceptors in the anterior cruciate ligament (ACL) has already been demonstrated in several studies. A similar effect can thus be imagined when the PCL is conserved in TKA. Three prospective randomized studies have attempted to demonstrate this. However, those three studies did not find any significant differences in clinical or functional results. It should be noted, however, that all those studies were carried out without the use of robotics or any other means of assessing PCL preservation.
Robotics have made it possible to obtain better results, as well as greater accuracy and reproducibility of the surgical procedure and better intraoperative laxity control based on the concept of functional alignment.
Mechanical alignment was the first to be used during insertion of the prosthetic knee. It facilitates alignment according to the tibial and femoral mechanical axis, and better implant survival thanks to improved stress distribution. However, the patient's anatomy is not respected, leading to a certain amount of patient dissatisfaction. The concept of kinematic (or anatomic) alignment was designed to achieve greater respect for patient anatomy and ligament balancing. More recently, with the advent of navigation and robotics, the authors have described functional alignment, which optimizes TKA alignment according to residual ligament tension.
Since robotic assistance provides better control of the procedure and, in particular, better preservation of PCL integrity in this surgical variant, we believe it is time to conduct a high-level evidence study comparing these two surgical techniques: preservation versus removal of the posterior cruciate ligament in knee arthroplasty. The investigators hypothesize that preserving the PCL will lead to better functional results, a better quality of life and an earlier return to activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCP+ group | Experimental | Robot-assisted total knee arthroplasty with conservation of the posterior cruciate ligament |
|
| LCP- group | Active Comparator | Robot-assisted total knee arthroplasty with ablation of the posterior cruciate ligament |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty | Procedure | Robot-assisted total knee arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rémy COULOMB, Dr | Contact | +334.66.68.31.56 | remy.coulomb@chu-nimes.fr | |
| Anissa MEGZARI | Contact | +33466684236 | drc@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pascal KOUYOUMDJIAN, Pr. | Nîmes University Hospital | Principal Investigator |
| Julien BARDOU-JACQUET, Dr. | Clinique Tivoli-Ducos, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Tivoli-Ducos | Recruiting | Bordeaux | 33000 | France |
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This is a prospective, multicenter, randomized (ratio 1:1), single-blind superiority study comparing two techniques for first-line robotic-assisted total knee replacement (MAKO): preservation of the posterior cruciate ligament (experimental group: "LCP+") versus ablation (control group: "LCP-") . Self-evaluation by the patient, blinded to the group he or she is in, at 12 months.
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The patient will not know whether he/she is in the LCP+ group (preservation of the posterior cruciate ligament) or the LCP- group.
| 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 |
| Sébastien LUSTIG, Pr. |
| Hôpital Croix Rousse, Lyon |
| Principal Investigator |
| Hôpital Croix Rousse | Recruiting | Lyon | 69317 | France |
|
| Nîmes University Hospital | Recruiting | Nîmes | 30029 | France |
|
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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