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NCT Number: NCT07757581

Customized Knee Arthroplasty With or Without Posterior Cruciate Ligament Retention: A CR-PS Approach

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Arthroplasty Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe hospitalier Diaconesses Croix Saint Simon

Paris, 75020, France

About this study

Prior to hospitalization, the study will be proposed to patients by telephone 21 days before surgery. Following explanation of the study, answering patient questions, and obtaining oral agreement, the information leaflet will be sent by mail for review until hospitalization, when written informed consent is obtained. After signing consent, participants are randomized to either the CR or PS group. Preoperative Phase:Active joint range of motion measured using a goniometer. Completion of patient-reported questionnaires: Forgotten Joint Score (FJS-12), Knee Injury and Osteoarthritis Outcome Score (KOOS), Subjective Knee Value (SKV), and Net Promoter Score (NPS). Standard preoperative imaging (weight-bearing radiographs, skyline view, goniometry) to assess anatomical alignment and plan implant positioning. Intraoperative Phase:Navigation data and surgical characteristics will be documented on the Case Report Form (CRF), including:Surgical approach and necessity for PCL or collateral ligament release. Rates of conversion from CR to PS prosthesis. Initial and final HKA angle and flexion contracture. Femoral and tibial resection parameters (thickness, slopes, cut obliquities, rotation). Thickness of the implanted polyethylene insert. Postoperative Follow-up Phase (3, 12, and 24 months):Distribution and completion of follow-up PROMs (FJS-12, KOOS, SKV, NPS) during routine follow-up visits. Evaluation of knee joint range of motion (ROM) and clinical stability. Assessment and recording of audible knee clicking, patellar complications, and surgery-related adverse events (including revision, manipulation under anesthesia, or prosthetic loosening).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice

Procedure

The approach, the need for posterior cruciate ligament or collateral ligament release, the need to change from a CR to a PS prosthesis and the duration of the procedure will be recorded on the data collection sheet with the implantation and measurement characteristics performed with the navigator:

  • HKA and initial and final flessums
  • Tibial cuts: thickness (max), slope, obliquity of cut
  • Femoral sections: distal and posterior thickness (max), mechanical femoral angle, rotation, femoral flessum, obliquity of cut.
  • Thickness of implanted polyethylene

Primary outcomes

  1. Forgotten Joint Score (FJS-12) at 24 Months Postoperatively

    Time frame: 24 months postoperatively

    Patient-reported joint awareness and functional outcome assessed using the Forgotten Joint Score (FJS-12) questionnaire. The total score ranges from 0 to 100, where 0 represents the worst outcome (high joint awareness) and 100 represents the best possible outcome (complete forgetfulness of the artificial joint). Higher scores indicate better functional outcome and joint naturalness.

Secondary outcomes

  1. Change from Baseline in Knee Range of Motion (ROM)

    Time frame: Baseline (preoperative), 3 months, 12 months, and 24 months postoperatively

    Knee flexion and extension range of motion (measured in degrees using a goniometer) evaluated preoperatively and postoperatively.

  2. Incidence of Audible Knee Clicking

    Time frame: 3 months, 12 months, and 24 months postoperatively.

    Percentage of patients reporting audible knee clicking during daily activities (excluding dynamic patellar clunk).

  3. Rate of Patellar Complications

    Time frame: Through 24 months postoperatively.

    Proportion of patients presenting with patellar complications, including patellar crepitus, patellar clunk syndrome, patellar tilt > 20 degrees, or patellar dislocation.

  4. Intraoperative Surgical Navigation and Alignment Parameters

    Time frame: Intraoperative (Day 0)

    Measurement of surgical alignment and resection parameters using navigation, including initial/final HKA angle, initial/final flexion contracture, tibial/femoral cut thickness (mm), slopes and cut obliquities (degrees), polyethylene thickness (mm), PCL release rates in CR, CR-to-PS conversion rates, and peripheral ligament release.

  5. Incidence of Surgery-Related Major Adverse Events

    Time frame: Through 24 months postoperatively

    Number of patients experiencing major surgical complications, defined as surgical revision, mobilization under general anesthesia, or prosthetic loosening.

  6. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Baseline (preoperative), 3 months, 12 months, and 24 months postoperatively

    Patient-reported outcome evaluating knee function, symptoms, pain, daily living activities, sports/recreation, and quality of life. Each subscale score ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems. Higher scores indicate better knee function and fewer symptoms.

  7. Forgotten Joint Score (FJS-12) at 3 and 12 Months Postoperatively

    Time frame: 3 months and 12 months postoperatively.

    Patient-reported joint awareness assessed using the FJS-12 questionnaire. Total score ranges from 0 to 100, where 0 represents the worst outcome and 100 represents the best possible outcome (higher scores indicate better outcome).

  8. Subjective Knee Value (SKV) Score

    Time frame: 3 months, 12 months, and 24 months postoperatively.

    Patient's self-assessment of their knee joint function as a percentage of a normal knee on a scale from 0% to 100%, where 0% represents a completely non-functional knee and 100% represents a fully normal knee. Higher scores indicate better joint function.

  9. Net Promoter Score (NPS) for Patient Satisfaction

    Time frame: 3 months, 12 months, and 24 months postoperatively.

    Single-item question assessing patient satisfaction and likelihood to recommend the surgical procedure to a friend or relative, rated on a scale from 0 ("not at all likely") to 10 ("extremely likely").

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Other

Registry information

Acronym: CR-PS

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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