12-month effects of keeping the posterior cruciate ligament during MAKO robotic-assisted total knee replacement
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.
Run by Centre Hospitalier Universitaire de Nīmes · NCT07489963 · Data updated 2026-11-12
This trial tests whether keeping the posterior cruciate ligament during MAKO robotic-assisted total knee replacement leads to better function at 12 months for people having a first-time unilateral knee replacement.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 3 sites (Bordeaux and 2 other locations) |
| Status | Recruiting |
| Started | October 10, 2025 |
| Main results expected | April 1, 2027 |
| Study ends | September 1, 2028 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07489963 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People scheduled for a first-intention, unilateral MAKO robotic-assisted total knee replacement who can consent, complete questionnaires, and attend usual 12-month follow-up are the intended participants.
✕Probably not a fit
Patients who cannot have the PCL retained intraoperatively (for example severe stiffness or deformity), those with prior PCL surgery, post‑traumatic arthritis, infection, severe valgus deformity, pregnancy, or legal incapacity are excluded and unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial compares two surgical approaches during MAKO robotic-assisted total knee arthroplasty: preservation of the posterior cruciate ligament (PCL) versus removal of the PCL. Participants scheduled for a first-time unilateral robotic-assisted TKA will receive one of the two approaches using standardized surgical protocols and the MAKO system. Clinical and patient-reported functional outcomes, including measures of stability and mobility, will be collected up to 12 months after surgery. The study is conducted at three French centers with planned follow-up visits and questionnaire assessments to capture outcomes at one year.
Why it matters
Potential benefit: If successful, keeping the PCL during robotic-assisted TKA could improve knee stability, proprioception, and patient-reported function at 12 months.
How similar studies have gone: Previous randomized prospective studies done before the robotic era did not find significant clinical or functional differences between PCL retention and resection, so this robotic-era comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Clinique Tivoli-Ducos
Bordeaux, France Recruiting -
Hôpital Croix Rousse
Lyon, France Recruiting -
Nîmes University Hospital
Nîmes, France Recruiting
Study contacts
- Principal investigator: Pascal KOUYOUMDJIAN, Pr. — Nîmes University Hospital
- Study coordinator: Rémy COULOMB, Dr
- Email: remy.coulomb@chu-nimes.fr
- Phone: +334.66.68.31.56
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.