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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Groupe hospitalier Diaconesses Croix Saint Simon
  Paris, Paris, France Recruiting

Study contacts

• Study coordinator: Younes KERROUMI, Clinical Research Physician
• Email: ykerroumi@hopital-dcss.org
• Phone: +33144643384

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.