Functional Impact at 12 Months Post-op of Posterior Cruciate Ligament Conservation During Robotic-assisted Surgery (MAKO) for Total Knee Replacement.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total knee arthroplasty.
- Who it may be relevant to
- Registry conditions: Knee Arthroplasty, Total. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Functional Impact at 12 Months Post-op of Posterior Cruciate Ligament Conservation During Robotic-assisted Surgery (MAKO) for Total Knee Replacement. A Randomized, Single-blind, Multicenter, Controlled Superiority Study.
Overview
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
Detailed description
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.
Interventions
- Procedure Total knee arthroplasty
Robot-assisted total knee arthroplasty
Primary outcome measures
- Functional impact at of posterior cruciate ligament preservation in the LCP+group [Time frame: 12 months post-surgery]
- Functional impact at of posterior cruciate ligament resection in the LCP-group [Time frame: 12 months post-surgery]
Secondary outcome measures (12)
- Functional impact at of posterior cruciate ligament preservation in the LCP+group [Time frame: 4.5 months post-surgery]
- Functional impact at of posterior cruciate ligament ablation in the LCP-group [Time frame: 4.5 months post-surgery]
- Algo-functional OKS (Oxford Knee Score) in the LCP+group [Time frame: 4.5 months post-surgery]
- Algo-functional OKS (Oxford Knee Score) in the LCP+group [Time frame: 12 months post-surgery]
- Algo-functional OKS (Oxford Knee Score) in the LCP-group [Time frame: 4.5 months post-surgery]
- Algo-functional OKS (Oxford Knee Score) in the LCP-group [Time frame: 12 months post-surgery]
- KSS (Knee Society Score) in the LCP+ group [Time frame: 4.5 months post-surgery]
- KSS (Knee Society Score) in the LCP+ group [Time frame: 12 months post-surgery]
- KSS (Knee Society Score) in the LCP- group [Time frame: 4.5 months post-surgery]
- KSS (Knee Society Score) in the LCP- group [Time frame: 12 months post-surgery]
- Radiological posterior laxity in the LCP+ group [Time frame: 4.5 months post-surgery]
- Radiological posterior laxity in the LCP+ group [Time frame: 12 months post-surgery]
Eligibility criteria
Inclusion criteria
- 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.
- Patient has given free and informed consent and has signed the consent form.
- Patient affiliated with or benefiting from a health insurance scheme.
Exclusion criteria
- Patient with intraoperative technical impossibility of retaining PCL (flessum > 20°, flexion stiffening < 100°).
- Previous posterior cruciate ligament surgery.
- Post-traumatic gonarthrosis.
- Valgus > 185°.
- Patient with septic complication.
- Patient participating in another interventional trial.
- Patient in an exclusion period determined by another study.
- Patient under court protection, guardianship or curatorship.
- Patient unable to give consent.
- Patients for whom it is impossible to provide informed information.
- Pregnant women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 3 centers
- Clinique Tivoli-Ducos — Bordeaux
- Hôpital Croix Rousse — Lyon
- Nîmes University Hospital — Nîmes
Identifiers
NCT: NCT07489963 · PHRCI/2023/RC01