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NCT Number: NCT06858358

Robotic Medial Congruent Vs. Conventional Medial Pivot TKA

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.

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Key information

Conditions

Knee Osteoarthristis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedLife Humanitas Hospital, Cluj-Napoca, Cluj, Romania

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with severe osteoarthritis (greater than III Ahlback)

Exclusion criteria

Patients who refuse participation in the study Low-grade osteoarthritis

Treatment and study plan

Robotic assisted total knee arthroplasty

Procedure
  • ROSA RATKA with Zimmer Biomet Persona Medial Congruent

Conventional total knee arthroplasty (cTKA)

Procedure

cTKA with Microport Evolution Medial-Pivot

Primary outcomes

  1. Polyethylene insert thickness

    Time frame: Perioperative/ Periprocedural

    Insert Thickness: Measured and analyzed in millimeters

  2. Mechanical axis outliers

    Time frame: Perioperative/ Periprocedural

    Outliers: Defined as more than 2.0 degrees from mechanical alignment, measured on full-leg X-ray

Secondary outcomes

  1. International knee documentation committe (IKDC) subjective score

    Time frame: 3, 6, and 12 months post-operative

    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).

  2. Forgotten joint score-12 (FJS-12)

    Time frame: 3, 6, and 12 months post-operative

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marian A Melinte

CONTACT

[email protected]

+40 728 923 062

Razvan M Melinte, MD, PhD

CONTACT

[email protected]

+40 722 331 327

Sponsors and collaborators

Lead sponsor

George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

Other

Collaborators

  • County Clinical Emergency Hospital Cluj-Napoca
  • Iuliu Hatieganu University of Medicine and Pharmacy

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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