Comparing robotic and conventional knee replacement methods
Comparison of Robotic-Assisted Medial Congruent and Conventional Medial Pivot Total Knee Arthroplasty: a Prospective, Multicenter Analysis
This study is testing whether robotic knee replacement surgery works better than traditional knee surgery for people with severe knee arthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures Academic / other |
| Locations | 2 sites (Cluj-Napoca, Cluj and 1 other locations) |
| Trial ID | NCT06858358 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective cohort study evaluates the effectiveness of Robotic-Assisted Total Knee Arthroplasty (RATKA) using a Medial Congruent implant against Conventional Total Knee Arthroplasty (cTKA) with a Medial Pivot design in patients with severe knee osteoarthritis. The study aims to assess clinical and functional outcomes, focusing on implant alignment, insert thickness accuracy, and patient satisfaction over 3, 6, and 12 months. Approximately 300 adults will participate, with outcomes measured through radiographic analysis and patient-reported outcomes. The study is conducted under local Institutional Review Board approvals and aims for publication in a high-impact orthopedic journal.
Who should consider this trial
Good fit: Ideal candidates are adults with severe osteoarthritis classified as greater than III Ahlback.
Not a fit: Patients with low-grade osteoarthritis or those who refuse participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved knee replacement outcomes and higher patient satisfaction.
How similar studies have performed: Other studies have shown promising results with robotic-assisted techniques in orthopedic surgery, suggesting potential benefits in precision and outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with severe osteoarthritis (greater than III Ahlback) Exclusion Criteria: Patients who refuse participation in the study Low-grade osteoarthritis
Where this trial is running
Cluj-Napoca, Cluj and 1 other locations
- MedLife Humanitas Hospital — Cluj-Napoca, Cluj, Romania (Recruiting)
- Medicover Cluj Hospital — Cluj-Napoca, Cluj, Romania (Recruiting)
Study contacts
- Study coordinator: Marian A Melinte
- Email: marianmelinte01@gmail.com
- Phone: +40 728 923 062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.