NCT06858358

Robotic Medial Congruent Vs. Conventional Medial Pivot TKA

Comparison of Robotic-Assisted Medial Congruent and Conventional Medial Pivot Total Knee Arthroplasty: a Prospective, Multicenter Analysis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Knee Osteoarthristis

Interventions

Type	Name	Description
PROCEDURE	Robotic assisted total knee arthroplasty	• ROSA RATKA with Zimmer Biomet Persona Medial Congruent
PROCEDURE	Conventional total knee arthroplasty (cTKA)	cTKA with Microport Evolution Medial-Pivot

Timeline

• Start date: 2025-02-24
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2025-03-05
• Last updated: 2025-03-05

Locations

2 sites across 1 country: Romania