An interventional study of Robotic assisted total knee arthroplasty and Conventional total knee arthroplasty (cTKA) in Knee Osteoarthristis, sponsored by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures. Recruiting at 2 sites in Romania. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures · Not applicable, Interventional, and Treatment
This multicenter, prospective cohort study will evaluate whether Robotic-Assisted total knee arthroplasty (RATKA) with a Medial Congruent implant is a successful method to improve implant alignment, insert thickness accuracy, and patient satisfaction, compared to a conventional TKA (cTKA) Medial Pivot technique. It aims to assess and compare clinical and functional outcomes in patients with severe knee osteoarthritis at 3, 6, and 12 months.
This prospective, non-randomized, multicenter trial evaluates robotic-assisted (ROSA® Robotic Platform with Zimmer Biomet Persona® Medial Congruent) versus conventional (MicroPort Evolution® Medial-Pivot) total knee arthroplasty (TKA) in approximately 300 adults with severe osteoarthritis. By comparing robotic precision with a well-established Medial-Pivot design, this investigation aims to clarify whether robotic-assisted TKA confers superior implant positioning, reduced alignment outliers, and enhanced patient-reported outcomes (PROMS). The primary outcome measures include insert thickness, alignment accuracy (outliers defined as >2° from the mechanical axis on full-leg radiographs), and patient satisfaction at 6 and 12 months. Two surgeons will perform both techniques, and one surgeon will perform only the conventional procedure. The 18-month study is conducted under local Institutional Review Board approvals (Medlife, Medicover, SCJU Cluj Napoca, Monza Bucuresti) and complies with GDPR. Results are intended for publication in a high-impact orthopedic journal. No external funding is provided.
George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with severe osteoarthritis (greater than III Ahlback)
Exclusion Criteria:
Patients who refuse participation in the study Low-grade osteoarthritis
Procedure: Robotic assisted total knee arthroplasty
Procedure: Conventional total knee arthroplasty (cTKA)
• ROSA RATKA with Zimmer Biomet Persona Medial Congruent
cTKA with Microport Evolution Medial-Pivot
Polyethylene insert thickness
Insert Thickness: Measured and analyzed in millimeters
Time frame: Perioperative/ Periprocedural
Mechanical axis outliers
Outliers: Defined as more than 2.0 degrees from mechanical alignment, measured on full-leg X-ray
Time frame: Perioperative/ Periprocedural
International knee documentation committe (IKDC) subjective score
The IKDC is a purely subjective assessment that assigns patients a functional overall rating. Three (3) categories are examined by the questionnaire: symptoms, athletic activity, and knee function. The symptoms subscale aids in evaluating issues like pain, stiffness, edema, and knee giving way. The ICC, which varies from 0.87 to 0.98, was deemed sufficient (\>0.70). Overall, it was discovered that the IKDC-SKF has positive test-retest reliability (Grevnerts et al. 2015). The IKDC subjective form scored acceptable for construct validity (84% confirmation of the predefined hypotheses) and responsiveness (86% confirmation of the predefined hypotheses) (van Meer et al. 2015).
Time frame: 3, 6, and 12 months post-operative
Forgotten joint score-12 (FJS-12)
The primary objective of the FJS-12 is to evaluate the extent to which patients "forget" their artificial joints during daily activities. A higher score indicates that the patient is less aware of their joint, suggesting better surgical outcomes and higher levels of patient satisfaction.
Time frame: 3, 6, and 12 months post-operative
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George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures