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

NCT07489963 | Recruiting

• 1 other identifier: PHRCI/2023/RC01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Knee Arthroplasty, Total

Keywords

Robot-Assisted Surgery; Knee Arthroplasty, Total

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (17)

• Functional impact at of posterior cruciate ligament preservation in the LCP+group

  4.5 months post-surgery

• Functional impact at of posterior cruciate ligament ablation in the LCP-group

  4.5 months post-surgery

• Algo-functional OKS (Oxford Knee Score) in the LCP+group

  4.5 months post-surgery

• Algo-functional OKS (Oxford Knee Score) in the LCP+group

  12 months post-surgery

• Algo-functional OKS (Oxford Knee Score) in the LCP-group

  4.5 months post-surgery

Study Arms (2)

LCP+ group

EXPERIMENTAL

Robot-assisted total knee arthroplasty with conservation of the posterior cruciate ligament

Procedure: Total knee arthroplasty

LCP- group

ACTIVE COMPARATOR

Robot-assisted total knee arthroplasty with ablation of the posterior cruciate ligament

Procedure: Total knee arthroplasty

Interventions

Total knee arthroplasty PROCEDURE

Robot-assisted total knee arthroplasty

LCP+ group; LCP- group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 under court protection, guardianship or curatorship.
• Patient unable to give consent.
• Patients for whom it is impossible to provide informed information.
• Pregnant women

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Clinique Tivoli Ducos: collaborator
• Hôpital de la Croix-Rousse: collaborator

Study Sites (3)

Clinique Tivoli-Ducos

Bordeaux, 33000, France

RECRUITING

Hôpital Croix Rousse

Lyon, 69317, France

RECRUITING

Nîmes University Hospital

Nîmes, 30029, France

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Pascal KOUYOUMDJIAN, Pr.

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

• Julien BARDOU-JACQUET, Dr.

  Clinique Tivoli-Ducos, Bordeaux

  PRINCIPAL INVESTIGATOR

• Sébastien LUSTIG, Pr.

  Hôpital Croix Rousse, Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rémy COULOMB, Dr

CONTACT

+334.66.68.31.56; remy.coulomb@chu-nimes.fr

Anissa MEGZARI

CONTACT

+33466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will not know whether he/she is in the LCP+ group (preservation of the posterior cruciate ligament) or the LCP- group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: October 10, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (3)