About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Robot-assisted surgery
Procedure/SurgeryOrthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system
Conventional total knee arthroplasty
Procedure/SurgeryOrthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide
Treatment groups
Trial outcomes
Primary outcomes
Postoperative patient satisfaction
Use a questionnaire to investigate patients' satisfaction with their knee joint after surgery
Forgotten Joint Scores
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.
WOMAC score
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.
Knee Society Score
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.
Secondary outcomes
SF-12
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.
visual analogue scale score
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
Range of motion
Physical examination to assess the knee's range of motion
Hip-knee-ankle angle
Measuring Hip-knee-ankle angle in radiology
Other outcomes
mLDFA
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.
mMPTA
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
Femoral prosthesis flexion angle (α angle)
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
Tibial posterior tilt angle (β angle):
on the standard lateral knee X-ray, the angle between the anatomical axis of the tibia and the lower surface of the tibial prosthesis.
Sponsors and contacts
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