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Early Clinical Benefits of Robot-Assisted vs Manual Total Knee Arthroplasty (RATKA-EARLY)

NCT07078149 · Hospital Universitario Santa Cristina · Updated 22 July 2025

What is being tested
Robotic-assisted TKA (RATKA).; Conventional manual TKA (mTKA)
For
Knee Osteoarthritis (Knee OA); Total Knee Arthroplasty
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 68 people. The full rules are on the registry page.
Where
Spain
When
Starts or started 28 March 2022, ends 16 Dec 2024. Registered 22 July 2025.
Results
None posted yet.

In the researchers' words

This study, called the RATKA-EARLY trial, was designed to compare two surgical techniques used in total knee replacement (also known as total knee arthroplasty or TKA). The aim was to determine whether the use of a robotic surgical system (ROSA® Knee System) offers short-term clinical advantages over the traditional manual technique. A total of 68 adult patients with advanced knee osteoarthritis scheduled for TKA were enrolled. Participants were randomly assigned to one of two groups: 34 patients underwent robot-assisted TKA (RATKA), and 34 underwent conventional manual TKA (mTKA). All surgeries were performed by the same experienced surgical team, using the same type of implant. Researchers assessed intraoperative and perioperative variables (such as surgical duration and blood loss), and evaluated early clinical outcomes at 3 months postoperatively by comparing pain levels, implant alignment, knee function, mobility, and overall patient satisfaction with baseline values. The study was conducted at Hospital Universitario Santa Cristina in Madrid, Spain. It was approved by the local ethics committee and carried out in accordance with the Declaration of Helsinki and international research guidelines. By comparing these two surgical approaches, the study aims to help patients and healthcare professionals make informed decisions regarding total knee replacement options.
ClinicalTrials.gov, NCT07078149

Sites

  • Hospital Universitario Santa CristinaMadrid, Spain