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

NCT07757581 | Active Not Recruiting

• 2 other identifiers: GHDCSS_SCAC2_CRPS_Ortho CRIOAC2023-A02516-39
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Arthroplasty; Osteoarthritis, Knee

Keywords

Total Knee Arthroplasty; Cruciate-Retaining; Posterior-Stabilized; Posterior Cruciate Ligament; Personalized Implantation

Outcome Measures

Primary Outcomes (1)

• Forgotten Joint Score (FJS-12) at 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.

  24 months postoperatively

Secondary Outcomes (9)

• Change from Baseline in Knee Range of Motion (ROM)

  Baseline (preoperative), 3 months, 12 months, and 24 months postoperatively

• Incidence of Audible Knee Clicking

  3 months, 12 months, and 24 months postoperatively.

• Rate of Patellar Complications

  Through 24 months postoperatively.

• Intraoperative Surgical Navigation and Alignment Parameters

  Intraoperative (Day 0)

• Incidence of Surgery-Related Major Adverse Events

  Through 24 months postoperatively

Study Arms (2)

A group of patients implanted with a knee prosthesis with preservation of the posterior cruciate (PC

EXPERIMENTAL

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

A group of patients implanted with a knee prosthesis without preservation of the posterior cruciate

EXPERIMENTAL

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

Interventions

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

A group of patients implanted with a knee prosthesis with preservation of the posterior cruciate (PC; A group of patients implanted with a knee prosthesis without preservation of the posterior cruciate

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe hospitalier Diaconesses Croix Saint Simon

Paris, 75020, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Simon MARMOR, Orthopedic surgeon

  Groupe Hospitalier Diaconesses Croix Saint-Simon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, open-label trial randomized in two parallel groups: A group of patients implanted with a knee prosthesis with preservation of the posterior cruciate ligament (CR). A group of patients implanted with a knee prosthesis without preservation of the posterior cruciate ligament (PS)

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: August 11, 2026
• Study Start: March 7, 2024
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)