Robotic Medial Congruent Vs. Conventional Medial Pivot TKA

Last updated: February 27, 2025
Sponsor: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Conventional total knee arthroplasty (cTKA)

Robotic assisted total knee arthroplasty

Clinical Study ID

NCT06858358
rosa_MP_MC_3002025
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with severe osteoarthritis (greater than III Ahlback)

Exclusion

Exclusion Criteria:

Patients who refuse participation in the study Low-grade osteoarthritis

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Conventional total knee arthroplasty (cTKA)
Phase:
Study Start date:
February 24, 2025
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • MedLife Humanitas Hospital

    Cluj-Napoca, Cluj 400664
    Romania

    Active - Recruiting

  • Medicover Cluj Hospital

    Cluj-Napoca, Cluj 407062
    Romania

    Active - Recruiting

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