Osteoarthritis
Conditions
Keywords
Robotic, Navigation, Arthroplasty, Osteoarthritis
Brief summary
Title: Personalized Total Knee Arthroplasty: Computer-Assisted Navigation vs. Robotic Assistance (CAN-ARD). Summary: Knee osteoarthritis is frequently treated with Total Knee Arthroplasty (TKA). However, approximately 20% of patients remain dissatisfied following the procedure. This study aims to compare two surgical assistance technologies designed to improve prosthetic placement accuracy: Computer-Assisted Navigation (CAN) and Robotic-Arm Assistance (RA). The primary objective is to determine if there is a significant difference in functional outcomes and the "forgotten joint" sensation (measured by the Forgotten Joint Score - FJS) between patients operated on with robotic assistance versus those with traditional navigation at 3, 12, and 24 months post-surgery. The study's hypothesis is that there is no major clinical difference between these two techniques when applied within a personalized alignment strategy.
Detailed description
Background and Rationale: Personalized alignment in total knee arthroplasty combines the restoration of the patient's unique anatomy (restricted kinematic alignment) with joint stability. While computer-assisted navigation has been successfully used since 2003 to plan and control implant positioning, robotic assistance is gaining popularity due to its ability to perform more precise bone cuts using a haptic robotic arm. This study seeks to investigate whether this technical gain in precision translates into a real clinical benefit for the patient in terms of satisfaction and joint perception. Study Design: This is an interventional, prospective, randomized, single-center study. A total of 140 patients (70 per group) will be enrolled. Interventions: Participants will be randomly assigned to one of the following two arms: Navigation Group: TKA implantation (Attune® CR) guided by an intraoperative computer navigation system. Robotic Group: TKA implantation using a robotic-arm-assisted system (a motorized saw linked to the navigation software). Follow-up and Evaluations: Patients will be followed for 24 months. Evaluations will include: Primary Endpoint: Forgotten Joint Score (FJS) at 3, 12, and 24 months. Secondary Endpoints: Satisfaction and functional scores (KOOS, SKV, Net Promoter Score), range of motion measurements, operative time, and monitoring of any complications. Target Population: Adults (≥ 18 years) scheduled for primary total knee arthroplasty for osteoarthritis, with no history of major bone surgery on the affected limb.
Interventions
DEVICERobotic-Arm Assisted Surgery (RA)
Total Knee Arthroplasty (TKA) performed using a robotic-arm-assisted system connected to navigation software. Like the navigation group, this arm utilizes the personalized alignment strategy and the Attune® CR prosthesis. Instead of manual cutting guides, the surgeon manipulates a robotic arm equipped with a motorized saw to perform the bone cuts according to the pre-planned digital model. This technology is intended to increase the precision of bone resections.
DEVICEComputer-Assisted Navigation (CAN)
Total Knee Arthroplasty (TKA) performed using an intraoperative computer navigation system. The procedure follows a personalized alignment strategy (restricted kinematic alignment combined with joint stability). After creating a digital model of the knee and mapping anatomical landmarks, the navigation system assists the surgeon in manually positioning the bone cutting guides. The primary implant used is the Attune® CR (Cruciate-Retaining) prosthesis with patellar resurfacing.
Sponsors
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Model Type: Parallel Assignment. Number of Arms: 2 arms (Navigation vs. Robotic). Allocation: Randomized. Masking: Single Blind (Outcomes Assessor). While the surgeon cannot be blinded to the technology used during the procedure, the functional outcomes and scores (FJS, KOOS, SKV) are typically assessed in a way to minimize bias, and the protocol notes a rigorous randomization procedure to ensure impartiality.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient providing written informed consent according to regulatory requirements * Male or female patients aged ≥18 years * Patients undergoing primary total knee arthroplasty for osteoarthritis * Use of Attune® prosthesis with posterior cruciate ligament retention (CR) and patellar resurfacing
Exclusion criteria
* History of ligament reconstruction * Previous fracture or bone surgery (osteotomy) of the ipsilateral femur or tibia (except hip or ankle surgery) * Preoperative knee stiffness with flexion contracture \>15° or flexion \<90° * Individuals deprived of liberty by judicial or administrative decision * Patients not affiliated with a social security system * Patients unable to understand French * Patients with cognitive impairment * Patients whose place of residence makes close clinical follow-up impossible -- Women of childbearing potential without effective contraception * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forgotten Joint Score (FJS). | 3, 12, and 24 months postoperatively. | Assessment of the patient's ability to forget the artificial joint in daily life. Minimum score: 0, Maximum score: 100. A higher score indicates a better outcome (the patient is less aware of the prosthetic joint) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS). | 3, 12, and 24 months postoperatively. | Evaluation of the patient's opinion about their knee and associated problems. Minimum score: 0, Maximum score: 100. A higher score represents a better outcome. |
| Self Knee Value (SKV). | 3, 12, and 24 months postoperatively. | Patient's subjective assessment of their knee as a percentage of a normal knee. Scale: 0% to 100%. A higher percentage represents a better outcome. |
| Net Promoter Score (NPS) | 3, 12, and 24 months postoperatively. | A single-question survey used to measure patient satisfaction and their willingness to recommend the surgical procedure to others. The score is calculated based on responses to a single question on a scale of 0 to 10 (where 0 is "not at all likely" and 10 is "extremely likely"). Respondents are grouped as Promoters (9-10), Passives (7-8), or Detractors (0-6). The final NPS is calculated by subtracting the percentage of Detractors from the percentage of Promoters, resulting in a score ranging from -100 to +100. A higher score indicates higher patient satisfaction |
| Active Range of Motion. | Preoperatively, and at 3 months, 12 months, and 24 months postoperatively. | Measurement of the active flexibility (extension and flexion) of the operated knee using a goniometer. Measured in degrees |
| Operative Time | During the surgical procedure (Day 0). | Total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure. |
| Incidence of Surgical and Postoperative Adverse Events. | Through 24 months postoperatively. | Documentation of complications including:Intraoperative: Technology-related issues or interruption of surgical assistance. Postoperative: Revision surgery, manipulation under anesthesia, or implant loosening. |
Countries
France
Contacts
CONTACTYounes KERROUMI, Clinical Research Physician
Outcome results
None listed