An interventional study of Robotic-Arm Assisted Surgery (RA) and Computer-Assisted Navigation (CAN) in Osteoarthritis, sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon · Not applicable, Interventional, and Health services research
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 140 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Groupe Hospitalier Diaconesses Croix Saint-Simon is the lead sponsor of 26 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Patients undergoing Prosthetic knee arthroplasty under robotic assistance
Device: Robotic-Arm Assisted Surgery (RA)
Patients undergoing Prosthetic knee arthroplasty under navigation assistance
Device: Computer-Assisted Navigation (CAN)
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.
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.
Forgotten Joint Score (FJS).
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)
Time frame: 3, 12, and 24 months postoperatively.
Knee Injury and Osteoarthritis Outcome Score (KOOS).
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.
Time frame: 3, 12, and 24 months postoperatively.
Self Knee Value (SKV).
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.
Time frame: 3, 12, and 24 months postoperatively.
Net Promoter Score (NPS)
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
Time frame: 3, 12, and 24 months postoperatively.
Active Range of Motion.
Measurement of the active flexibility (extension and flexion) of the operated knee using a goniometer. Measured in degrees
Time frame: Preoperatively, and at 3 months, 12 months, and 24 months postoperatively.
Operative Time
Total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure.
Time frame: During the surgical procedure (Day 0).
Incidence of Surgical and Postoperative Adverse Events.
Documentation of complications including:Intraoperative: Technology-related issues or interruption of surgical assistance. Postoperative: Revision surgery, manipulation under anesthesia, or implant loosening.
Time frame: Through 24 months postoperatively.
Plan to share: No
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Groupe Hospitalier Diaconesses Croix Saint-Simon