Knee Arthroplasty, TotalLCPTGNCT07489963
Functional Impact at 12 Months Post-op of Posterior Cruciate Ligament Conservation During Robotic-assisted Surgery (MAKO) for Total Knee Replacement.
A study testing Total knee arthroplasty in people with Knee Arthroplasty, Total, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesFrance
- Study dates
- 10 Oct 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Clinique Tivoli-Ducos
Bordeaux, 33000
Julien BARDOU-JACQUET, Dr., +335.40.41.70.14, jbardoujacquet@me.com
- Recruiting
Hôpital Croix Rousse
Lyon, 69317
Sébastien LUSTIG, Pr., +334.26.10.92.47, sebastien.lustig@gmail.com
- Recruiting
Nîmes University Hospital
Nîmes, 30029
Rémy COULOMB, Dr., +334.66.68.31.56, remy.coulomb@chu-nimes.fr
About this study
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.
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
Read the 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.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Total knee arthroplasty
- Keywords
- Robot-Assisted Surgery, Knee Arthroplasty, Total
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Robot-assisted total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| LCP+ group | Experimental | Robot-assisted total knee arthroplasty with conservation of the posterior cruciate ligament Receives: Procedure: Total knee arthroplasty |
| LCP- group | Active comparator | Robot-assisted total knee arthroplasty with ablation of the posterior cruciate ligament Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 12 months post-surgery
Secondary outcomes (17)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post-surgery
Radiological posterior laxity in the LCP+ group
Qualitative. Radiological examination as part of standard treatment.
Measured: 4.5 months post-surgery
Radiological posterior laxity in the LCP+ group
Qualitative. Radiological examination as part of standard treatment.
Measured: 12 months post-surgery
Radiological posterior laxity in the LCP- group
Qualitative. Radiological examination as part of standard treatment.
Measured: 4.5 months post-surgery
Radiological posterior laxity in the LCP- group
Qualitative. Radiological examination as part of standard treatment.
Measured: 12 months post-surgery
Cost to the community of the care pathway associated with rehabilitation in the LCP+ group
Quantitative, in Euros per patient.
Measured: 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.
Measured: 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
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start10 Oct 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique Tivoli Ducos, Hôpital de la Croix-Rousse
- Responsible party
- Sponsor
- Investigators
- Pascal KOUYOUMDJIAN, Pr., Principal investigator, Nîmes University HospitalJulien BARDOU-JACQUET, Dr., Principal investigator, Clinique Tivoli-Ducos, BordeauxSébastien LUSTIG, Pr., Principal investigator, Hôpital Croix Rousse, Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489963
- Sponsor's protocol ID
- PHRCI/2023/RC01
- Acronym
- LCPTG
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07489963
- Acronym / sponsor ID
- LCPTG / PHRCI/2023/RC01
- Conditions
- Knee Arthroplasty, Total
- Keywords
- Robot-Assisted Surgery, Knee Arthroplasty, Total
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Clinique Tivoli Ducos, Hôpital de la Croix-Rousse
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| LCP+ group | Experimental | Procedure: Total knee arthroplastyRobot-assisted total knee arthroplasty with conservation of the posterior cruciate ligament |
| LCP- group | Active comparator | Procedure: Total knee arthroplastyRobot-assisted total knee arthroplasty with ablation of the posterior cruciate ligament |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplastyRobot-assisted total knee arthroplasty | Procedure or surgery | LCP+ group, LCP- group |
Primary outcome
Functional impact at of posterior cruciate ligament preservation in the LCP+group
Time frame: 12 months post-surgery
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).
Functional impact at of posterior cruciate ligament resection in the LCP-group
Time frame: 12 months post-surgery
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).
17 secondary outcomes
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
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
Cost to the community of the care pathway associated with rehabilitation in the LCP+ group
Time frame: Up to 12 months after surgery
Cost to the community of the care pathway associated with rehabilitation in the LCP- group
Time frame: 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
Time frame: Up to 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pascal KOUYOUMDJIAN, Pr. principal investigator
Nîmes University Hospital
Julien BARDOU-JACQUET, Dr. principal investigator
Clinique Tivoli-Ducos, Bordeaux
Sébastien LUSTIG, Pr. principal investigator
Hôpital Croix Rousse, Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty in people with Knee Arthroplasty, Total, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rémy COULOMB, Dr (+334.66.68.31.56, remy.coulomb@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional impact at of posterior cruciate ligament preservation in the LCP+group (time frame: 12 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.