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| Name | Class |
|---|---|
| Inner Mongolia People's Hospital | OTHER |
| Jining Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D printed personalized TKA prosthesis | Experimental | Design:Personalized TKA prosthesis Manufacture:3D |
|
| Zimmer NexGen TKA prostheses | Active Comparator | Prosthesis has been widely used in clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized TKA prosthesis | Device | TKA prosthesis that is designed and manufactured according to the patient's knee joint anatomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Osteotomy during TKA | The size of the osteotomy | during surgery |
| Operation time | operation time | during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fu-zhen Yuan | Contact | 18511440808 | yuanfuzhen2016@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia-kuo Yu | Peking University Third Hospital | Study Director |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Zimmer NexGen prostheses | Device | Commercial products used on a large scale |
|
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | 7 days postoperatively |
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | 3months postoperatively |
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | 6 months postoperatively |
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | 12 months postoperatively |
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | 7 days postoperatively |
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | 3months postoperatively |
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | 6 months postoperatively |
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | 12 months postoperatively |
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | 7 days postoperatively |
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | 3months postoperatively |
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | 6 months postoperatively |
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | 12 months postoperatively |
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | 7 days postoperatively |
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | 3months postoperatively |
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | 6 months postoperatively |
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | 12 months postoperatively |
| D012216 |
| Rheumatic Diseases |