the first affiliated hospital of USTC
Hefei, Anhui, 230001, China
Location status: Recruiting
Location contact
Chen Zhu, M.D
CONTACT
NCT Number: NCT06856356
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Hefei, Anhui, 230001, China
Location status: Recruiting
Chen Zhu, M.D
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Orthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system
Orthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
Use a questionnaire to investigate patients' satisfaction with their knee joint after surgery
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
The Forgotten Joint Score (FJS) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total knee arthroplasty.The total score is 100 points. The higher the score, the better the degree of forgetfulness of the artificial joint.
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
Use WOMAC scoring scale to assess the condition of the knee joint. The WOMAC score consists of 24 items with a total score of 100. The higher the score, the more severe the limitation of joint function.
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
The KSS score was assessed using the American Knee Society scoring criteria.The full score is 100 points. The higher the score, the better the patient's knee function.
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
The health status of patients was assessed using the SF-12 health-related quality of life scale. The higher the score, the better the quality of life.
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
Visual analogue scale (VAS) for pain assessment。0 means no pain, 10 means the most painful, the higher the value, the higher the pain level of the patient
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
Physical examination to assess the knee's range of motion
Time frame: postoperative Day 1-3
Measuring Hip-knee-ankle angle in radiology
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
Record the patient's postoperative complications. For example, Persistent pain, fracture, superficial local infection, infection, thromboembolism.
Time frame: preoperative Day 1-3, postoperative Day 1-3
the lateral angle between the mechanical axis of the femur and the tangent of the distal end of the femoral prosthesis. The target value is 90°. >90° is varus, and <90° is valgus. Varus or valgus exceeding 3° is defined as femoral prosthesis position deviation.
Time frame: preoperative Day 1-3, postoperative Day 1-3
medial angle between the mechanical axis of the tibia and the tangent of the tibial prosthesis, the target value is 90°, <90° is varus, >90° is valgus, and valgus exceeding 3° is defined as tibial prosthesis position deviation
Time frame: preoperative Day 1-3, postoperative Day 1-3
on the standard lateral knee X-ray, the angle between the anatomical axis of the distal femur and the vertical line of the distal femoral prosthesis
Time frame: preoperative Day 1-3, postoperative Day 1-3
on the standard lateral knee X-ray, the angle between the anatomical axis of the tibia and the lower surface of the tibial prosthesis.
Contact information is provided by the study sponsor or research team.
Xianyue Shen, M.D
CONTACT
Xianzuo Zhang, Ph.D
CONTACT
The First Affiliated Hospital of University of Science and Technology of China
Other
Comparison of Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty and Conventional Total Knee Arthroplasty: a Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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