This study aims to evaluate the effectiveness of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis of semi-individualized total knee replacement prostheses designed with gender differences; and compare and analyze with the current classic prostheses, showing gender differences. The designed semi-personalized total knee replacement prosthesis lays the foundation for clinical application, including: 1. Compared with the classic osteotomy method, compare whether the semi-individualized total knee arthroplasty with a gender-specific design has advantages and better safety in the osteotomy method. 2. To evaluate the difference between the amount of osteotomy in the semi-individualized total knee arthroplasty designed for gender differences and the amount of classic osteotomy. 3. Compared with classic prostheses in the market, verify the clinical effects of semi-individualized total knee replacement prostheses designed for gender differences, and provide a basis for their clinical promotion and application.
Patients meeting the inclusion and exclusion criteria were divided into the experimental group and the control group according to the patient's wishes. Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design. The control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,600
Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design.
Patients in the control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).
lower limb alignment
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; (-3 3)is normal, The more out of this range, the worse.
Time frame: Before operation
lower limb alignment
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; (-3 3)is normal, The more out of this range, the worse.
Time frame: 5 days after operation
lower limb alignment
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; (-3 3)is normal, The more out of this range, the worse.
Time frame: 6 months after operation
lower limb alignment
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; (-3 3)is normal, The more out of this range, the worse.
Time frame: 12 months after operation
Knee prosthesis position
Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis,180° is normal. The more deviated from 180°, the worse.
Time frame: 5 days after operation
Knee prosthesis position
Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis,180° is normal. The more deviated from 180°, the worse.
Time frame: 6 months after operation
Knee prosthesis position
Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis,180° is normal. The more deviated from 180°, the worse.
Time frame: 12 months after operation
Gait analysis
Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement.
Time frame: 5 days after operation
Gait analysis
Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement.
Time frame: 6 months after operation
Gait analysis
Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement.
Time frame: 12 months after operation
Operation time
from cutting the skin to completing the suture of the incision
Time frame: during surgery
The amount of bleeding
from cutting the skin to completing the suture of the incision
Time frame: during surgery
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Time frame: Before operation
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Time frame: 5 days after operation
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Time frame: 6 months after operation
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Time frame: 12 months after operation
KSS score
knee society score, the scale is 0-200 and 0 is worse.
Time frame: Before operation
KSS score
knee society score, the scale is 0-200 and 0 is worse.
Time frame: 5 days after operation
KSS score
knee society score, the scale is 0-200 and 0 is worse.
Time frame: 6 months after operation
KSS score
knee society score, the scale is 0-200 and 0 is worse.
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Time frame: 12 months after operation
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time frame: Before operation
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time frame: 5 days after operation
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time frame: 6 months after operation
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time frame: 12 months after operation
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time frame: Before operation
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time frame: 5 days after operation
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time frame: 6 months after operation
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time frame: 12 months after operation