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

NCT07078149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Knee Osteoarthritis (Knee OA)
  • Total Knee Arthroplasty

Interventions

DEVICE

Robotic-assisted TKA (RATKA).

RATKA was performed using the ROSA® Knee System.

PROCEDURE

Conventional manual TKA (mTKA)

mTKA was performed without robot assistance.

Sponsors & Collaborators

  • Hospital Universitario Santa Cristina

    lead OTHER

Principal Investigators

  • Inmaculada Neira, M.D. · Hospital Universitario Santa Cristina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2024-10-30
Completion
2024-12-16

Countries

  • Spain

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 NCT07078149 on ClinicalTrials.gov