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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthristis
• Intervention / Treatment: Procedure: Robotic assisted total knee arthroplasty; Procedure: Conventional total knee arthroplasty (cTKA)

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marian A Melinte; Phone Number: +40 728 923 062; Email: marianmelinte01@gmail.com
• Study Contact Backup: Name: Razvan M Melinte, MD, PhD; Phone Number: +40 722 331 327; Email: razvanmel@xnet.ro

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400664
      • Recruiting
      • MedLife Humanitas Hospital
      • Contact: Razvan M Melinte, MD, PhD; Phone Number: +40 722 331 327; Email: razvanmel@xnet.ro
    • Cluj-Napoca, Cluj, Romania, 407062
      • Recruiting
      • Medicover Cluj Hospital
      • Contact: Horea Benea, MD, PhD; Phone Number: +40 724 528 188; Email: programari.cluj@medicover.ro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients with severe osteoarthritis (greater than III Ahlback)

Exclusion Criteria:

Patients who refuse participation in the study Low-grade osteoarthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ROSA Robotic-assisted TKA with Zimmer Biomet Persona Medial Congruent implant	Procedure: Robotic assisted total knee arthroplasty; • ROSA RATKA with Zimmer Biomet Persona Medial Congruent
Experimental: Conventional TKA with Microport Evolution Medial-Pivot	Procedure: Conventional total knee arthroplasty (cTKA); cTKA with Microport Evolution Medial-Pivot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyethylene insert thickness	Insert Thickness: Measured and analyzed in millimeters	Perioperative/ Periprocedural
Mechanical axis outliers	Outliers: Defined as more than 2.0 degrees from mechanical alignment, measured on full-leg X-ray	Perioperative/ Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	3, 6, and 12 months post-operative

Collaborators and Investigators

• Sponsor: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
• Collaborators: Iuliu Hatieganu University of Medicine and Pharmacy; County Clinical Emergency Hospital Cluj-Napoca

Study record dates

Study Major Dates

• Study Start (Estimated): February 24, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Robotic; Knee arthroplasty; TKA; ROSA
• Other Study ID Numbers: rosa_MP_MC_3002025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No