Robotic Medial Congruent Vs. Conventional Medial Pivot TKA

George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures (UMFST)

Status: Enrolling

Conditions: Knee Osteoarthristis

Treatments: Procedure: Robotic assisted total knee arthroplasty; Procedure: Conventional total knee arthroplasty (cTKA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06858358

rosa_MP_MC_3002025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with severe osteoarthritis (greater than III Ahlback)

Exclusion criteria

Patients who refuse participation in the study Low-grade osteoarthritis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

ROSA Robotic-assisted TKA with Zimmer Biomet Persona Medial Congruent implant

Experimental group

Treatment:

Procedure: Robotic assisted total knee arthroplasty

Conventional TKA with Microport Evolution Medial-Pivot

Experimental group

Treatment:

Procedure: Conventional total knee arthroplasty (cTKA)