Knee Arthroplasty, Osteoarthritis, Knee
Conditions
Keywords
Total Knee Arthroplasty, Cruciate-Retaining, Posterior-Stabilized, Posterior Cruciate Ligament, Personalized Implantation
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.
Detailed description
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).
Interventions
PROCEDUREImplantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice
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
Sponsors
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forgotten Joint Score (FJS-12) at 24 Months Postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Knee Range of Motion (ROM) | 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. |
| Incidence of Audible Knee Clicking | 3 months, 12 months, and 24 months postoperatively. | Percentage of patients reporting audible knee clicking during daily activities (excluding dynamic patellar clunk). |
| Rate of Patellar Complications | Through 24 months postoperatively. | Proportion of patients presenting with patellar complications, including patellar crepitus, patellar clunk syndrome, patellar tilt \> 20 degrees, or patellar dislocation. |
| Intraoperative Surgical Navigation and Alignment Parameters | 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. |
| Incidence of Surgery-Related Major Adverse Events | Through 24 months postoperatively | Number of patients experiencing major surgical complications, defined as surgical revision, mobilization under general anesthesia, or prosthetic loosening. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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. |
| Forgotten Joint Score (FJS-12) at 3 and 12 Months Postoperatively | 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). |
| Subjective Knee Value (SKV) Score | 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. |
| Net Promoter Score (NPS) for Patient Satisfaction | 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"). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORSimon MARMOR, Orthopedic surgeon
Groupe Hospitalier Diaconesses Croix Saint-Simon
Outcome results
None listed