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Recruiting NCT06856356

Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty

No phase Interventional Osteoarthritis, Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robot-assisted surgery, Conventional total knee arthroplasty.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Postoperative patient satisfaction [Time frame: Month 1, Month 3, Month 6, Month 12, Month 24]
  • Forgotten Joint Scores [Time frame: Month 1, Month 3, Month 6, Month 12, Month 24]
  • WOMAC score [Time frame: Month 1, Month 3, Month 6, Month 12, Month 24]
  • Knee Society Score [Time frame: Month 1, Month 3, Month 6, Month 12, Month 24]
Secondary outcome measures (5)
  • SF-12 [Time frame: Month 1, Month 3, Month 6, Month 12, Month 24]
  • visual analogue scale score [Time frame: Month 1, Month 3, Month 6, Month 12, Month 24]
  • Range of motion [Time frame: Month 1, Month 3, Month 6, Month 12, Month 24]
  • Hip-knee-ankle angle [Time frame: postoperative Day 1-3]
  • Complication [Time frame: Month 1, Month 3, Month 6, Month 12, Month 24]

Eligibility criteria

Inclusion criteria

  • Subjects voluntarily participate in the trial and sign the informed consent form;
  • Aged 18 to 80 years old (inclusive), regardless of gender;
  • Patients who need total knee replacement surgery;
  • Those who can communicate well with the researchers and comply with the trial requirements.

Exclusion criteria

  • Patients who are allergic to the drugs used in this trial or the implant materials;
  • Patients with immature bone development;
  • Patients with active infection;
  • Patients with neuropathy of the knee joint;
  • Patients with poor bone quality that is not conducive to prosthesis fixation;
  • Patients with general conditions or concomitant diseases that make it difficult for people to tolerate surgery;
  • Patients with insufficient quadriceps muscle strength;
  • Patients with insufficient skin coverage near the surgical site and intolerance to surgery;
  • Patients with severe femoral or tibial deformities and other severe deformities outside the joint;
  • Patients with metal implants in the joint surgical area that affect the execution of the surgical plan;
  • Pregnant or lactating women;
  • Patients with severe epilepsy or mental illness;
  • Patients with alcohol dependence or drug addiction;
  • Patients with severe coagulation disorders;
  • Patients who have participated in or are participating in other clinical trials within one month of enrollment;
  • Patients who are considered by the researchers to be unsuitable for participating in this clinical trial for other reasons. Those who meet any of the above exclusion criteria need to be excluded.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • the first affiliated hospital of USTC — Hefei

Identifiers

NCT: NCT06856356 · XJS2023-1-18(WK)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗