The subject is planned to carry out the clinical trails of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis; At the same time, in order to achieve personalized precision bone resection, the clinical trial verification is carried out on the personalized cutting guides.
The subject continues the research of Professor Jia-kuo Yu's research group on the personalized design, processing and manufacturing of personalized total knee arthroplasty (TKA) prostheses and the verification of animal and human cadavers. It is planned to carry out the clinical trails of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis; At the same time, in order to achieve personalized precision bone resection, the clinical trial verification is carried out on the personalized cutting guides. In the clinical validation study, the research team will summarize the role of personalized TKA prostheses and personalized TKA cutting guides in the precise and minimally invasive treatment of knee osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
TKA prosthesis that is designed and manufactured according to the patient's knee joint anatomy
Commercial products used on a large scale
Mechanical axis of the lower limb and prosthesis position
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Time frame: 7 days postoperatively
Mechanical axis of the lower limb and prosthesis position
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Time frame: 3months postoperatively
Mechanical axis of the lower limb and prosthesis position
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Time frame: 6 months postoperatively
Mechanical axis of the lower limb and prosthesis position
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Time frame: 12 months postoperatively
Osteotomy during TKA
The size of the osteotomy
Time frame: during surgery
Operation time
operation time
Time frame: during surgery
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Time frame: 7 days postoperatively
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3months postoperatively
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Time frame: 6 months postoperatively
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Time frame: 12 months postoperatively
KSS score
knee society score, the scale is 0-200 and 0 is worse.
Time frame: 7 days postoperatively
KSS score
knee society score, the scale is 0-200 and 0 is worse.
Time frame: 3months postoperatively
KSS score
knee society score, the scale is 0-200 and 0 is worse.
Time frame: 6 months postoperatively
KSS score
knee society score, the scale is 0-200 and 0 is worse.
Time frame: 12 months postoperatively
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time frame: 7 days postoperatively
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time frame: 3months postoperatively
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time frame: 6 months postoperatively
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time frame: 12 months postoperatively
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time frame: 7 days postoperatively
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time frame: 3months postoperatively
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time frame: 6 months postoperatively
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time frame: 12 months postoperatively