RecruitingNot ApplicableNCT07489963

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

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.


Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrollment

300 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria11

  • 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

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Interventions

PROCEDURETotal knee arthroplasty

Robot-assisted total knee arthroplasty


Locations(3)

Clinique Tivoli-Ducos

Bordeaux, France

Hôpital Croix Rousse

Lyon, France

Nîmes University Hospital

Nîmes, France

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NCT07489963


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