Customized Knee Arthroplasty With or Without Posterior Cruciate Ligament Retention: A CR-PS Approach (NCT07757581) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Customized Knee Arthroplasty With or Without Posterior Cruciate Ligament Retention: A CR-PS Approach
France140 participantsStarted 2024-03-07
Plain-language summary
Background and Rationale:
Conventional mechanical implantation of total knee arthroplasty (TKA) aims to establish a lower-limb mechanical axis of 180°. Computer-assisted personalized implantation aims to restore a pre-arthritic alignment while respecting the soft-tissue envelope of the knee. Depending on design, TKA implants may either retain or sacrifice the posterior cruciate ligament (PCL). In mechanically implanted TKAs, functional outcomes of cruciate-retaining (CR) and posterior-stabilized (PS) designs are reported as comparable in the literature. However, these two designs have not been compared within a computer-assisted personalized implantation workflow. Objective and Hypothesis:
The objective of this randomized comparative study is to compare functional outcomes (patient-reported outcome measures - PROMs) at 24 months postoperatively following CR versus PS knee arthroplasty implanted with a personalized technique. The hypothesis is that there is no significant difference in functional outcomes between CR and PS prostheses implanted using a personalized technique. Study Design:
Single-center, open-label, randomized, two-arm parallel-group trial comparing a group of patients receiving a cruciate-retaining (CR) total knee prosthesis to a group receiving a posterior-stabilized (PS) total knee prosthesis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient information provided and signed written informed consent obtained in duplicate
* Male and female participants aged 18 years or older
* Primary total knee arthroplasty for knee osteoarthritis performed in the orthopaedic surgery department
Exclusion Criteria:
* History of posterior cruciate ligament (PCL) rupture or prior ligamentoplasty
* History of ipsilateral femur or tibia fracture
* Coronal plane axial deviation greater than 15 degrees (HKA \< 165° or \> 195°)
* Flexion contracture (flexum) greater than 15 degrees
* Tibial slope greater than 10 degrees
* Patient deprived of liberty by judicial or administrative decision
* Patient not affiliated with or beneficiary of a national social security scheme
* Patient unable to understand French
* Patient whose place of residence is incompatible with close in-person follow-up consultations
* Woman of childbearing potential not using effective contraception
* Pregnant or breastfeeding woman
* Adult patient unable or unfit to give informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Forgotten Joint Score (FJS-12) at 24 Months Postoperatively