Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty

Last updated: February 26, 2025
Sponsor: The First Affiliated Hospital of University of Science and Technology of China
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Conventional total knee arthroplasty

Robot-assisted surgery

Clinical Study ID

NCT06856356
XJS2023-1-18(WK)
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects voluntarily participate in the trial and sign the informed consent form;

  2. Aged 18 to 80 years old (inclusive), regardless of gender;

  3. Patients who need total knee replacement surgery;

  4. Those who can communicate well with the researchers and comply with the trialrequirements.

Exclusion

Exclusion Criteria:

  1. Patients who are allergic to the drugs used in this trial or the implant materials;

  2. Patients with immature bone development;

  3. Patients with active infection;

  4. Patients with neuropathy of the knee joint;

  5. Patients with poor bone quality that is not conducive to prosthesis fixation;

  6. Patients with general conditions or concomitant diseases that make it difficult forpeople to tolerate surgery;

  7. Patients with insufficient quadriceps muscle strength;

  8. Patients with insufficient skin coverage near the surgical site and intolerance tosurgery;

  9. Patients with severe femoral or tibial deformities and other severe deformitiesoutside the joint;

  10. Patients with metal implants in the joint surgical area that affect the execution ofthe surgical plan;

  11. Pregnant or lactating women;

  12. Patients with severe epilepsy or mental illness;

  13. Patients with alcohol dependence or drug addiction;

  14. Patients with severe coagulation disorders;

  15. Patients who have participated in or are participating in other clinical trialswithin one month of enrollment;

  16. Patients who are considered by the researchers to be unsuitable for participating inthis clinical trial for other reasons. Those who meet any of the above exclusioncriteria need to be excluded.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Conventional total knee arthroplasty
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • the first affiliated hospital of USTC

    Hefei, Anhui 230001
    China

    Active - Recruiting

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