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Robotic Medial Congruent Vs. Conventional Medial Pivot TKA

NCT06858358 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-03-05

No results posted yet for this 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.

Conditions

  • Knee Osteoarthristis

Interventions

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

Sponsors & Collaborators

  • Iuliu Hatieganu University of Medicine and Pharmacy

    collaborator OTHER

  • County Clinical Emergency Hospital Cluj-Napoca

    collaborator OTHER

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

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2026-07-31
Completion
2026-09-30

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06858358 on ClinicalTrials.gov