NCT06856356

Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty

Comparison of Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty and Conventional Total Knee Arthroplasty: a Randomized Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital of University of Science and Technology of China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to understand the application value of the Orthopedic Joint Surgery Navigation System in assisting surgeons to accurately place prosthetic components in adult knee replacement surgery. It will also confirm its effectiveness and safety in clinical application.

Detailed description

The purpose of this clinical trial is to understand the application value of the Orthopedic Joint Surgery Navigation System in assisting surgeons to accurately place prosthetic components in adult knee replacement surgery. It will also confirm its effectiveness and safety in clinical application. The main questions it aims to answer are: Does the Orthopedic Joint Surgery Navigation System improve the accuracy of prosthetic component placement in knee replacement surgery? Is the Orthopedic Joint Surgery Navigation System superior to traditional total knee replacement What medical problems do participants encounter when taking medication ABC? Researchers will compare the Orthopedic Joint Surgery Navigation System with traditional total knee replacement surgery (using a "four-in-one" osteotomy guide) to see if the Orthopedic Joint Surgery Navigation System is superior to traditional total knee replacement in terms of prosthesis three-dimensional position, force alignment, patient satisfaction, functional scores, complications, etc. Participants will: End-stage knee osteoarthritis patients receive total knee replacement with the Orthopedic Joint Surgery Navigation System or traditional total knee replacement surgery Visit the clinic for examination and testing every 3 months Record their imaging data, satisfaction, functional scores, complications, etc.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
PROCEDURE	Robot-assisted surgery	Orthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system
PROCEDURE	Conventional total knee arthroplasty	Orthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-06-30
• Completion: 2026-12-31
• First posted: 2025-03-04
• Last updated: 2025-03-04

Locations

1 site across 1 country: China