Personalized total knee replacement: computer navigation versus robotic-arm assistance

Total Knee Replacement With Personalized Implantation Navigation-assisted Surgery Versus Robotic Assistance "CAN-ARD"

We test whether robotic-arm assistance or computer navigation during personalized total knee replacement gives adults with knee osteoarthritis a more natural-feeling knee and better function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon (other)
• Locations: 1 site (Paris, Paris)
• Trial ID: NCT07574762 on ClinicalTrials.gov

What this trial studies

Adults with knee osteoarthritis scheduled for primary total knee arthroplasty will be randomized at a single Paris center to receive the same Attune® CR implant using either intraoperative computer-assisted navigation or a robotic-arm–assisted system within a restricted kinematic (personalized) alignment strategy. A total of 140 patients (70 per arm) will be followed for 24 months with the primary outcome the Forgotten Joint Score measured at 3, 12, and 24 months and secondary outcomes including KOOS, satisfaction, range of motion, operative time, and complications. The robotic arm provides haptic-guided bone cutting while navigation guides implant positioning, and both approaches use the same implant and alignment philosophy to isolate the effect of the assistance technology. Randomization and standardized follow-up are used to determine whether any increased technical precision with robotics translates into measurable patient-perceived benefits.

Who should consider this trial

Good fit: Adults (≥18 years) with knee osteoarthritis scheduled for a primary total knee arthroplasty who can provide informed consent, understand French, and are planned for an Attune® CR implant with patellar resurfacing.

Not a fit: Patients with prior ipsilateral femoral or tibial osteotomy or fracture surgery, prior ligament reconstruction, severe preoperative stiffness, cognitive impairment, inability to attend follow-up in Paris, non-French speakers, or pregnant/breastfeeding women are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If one approach produces better Forgotten Joint Scores and satisfaction, it could lower the proportion of patients dissatisfied after knee replacement and improve everyday knee comfort.

How similar studies have performed: Computer-assisted navigation has long improved implant positioning and robotic systems increase bone-cut precision, but previous clinical comparisons have shown mixed or limited evidence that these technical improvements consistently produce superior patient-reported outcomes.

Eligibility criteria

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

Where this trial is running

Paris, Paris

• Groupe hospitalier Diaconesses Croix Saint Simon — Paris, Paris, France (RECRUITING)

Study contacts

• Study coordinator: Younes KERROUMI, Clinical Research Physician

Conditions: Osteoarthritis, Robotic, Navigation, Arthroplasty