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| Name | Class |
|---|---|
| Guizhou Orthopedics Hospital | UNKNOWN |
| Shenyang Orthopedic Hospital | OTHER |
| West China Hospital | OTHER |
| Xi'an Honghui Hospital |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test group | Experimental | Semi-individualized total knee arthroplasty |
|
| Control group | Active Comparator | Zimmer standard prosthesis total knee replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semi-individualized total knee replacement treatment with a gender-specific design | Procedure | Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | 6 months after operation |
| Knee prosthesis position |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | from cutting the skin to completing the suture of the incision | during surgery |
| The amount of bleeding | from cutting the skin to completing the suture of the incision |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiakuo Yu, Doctor | Contact | 13331031448 | yujiakuo@126.com | |
| Fuzhen Yuan, Doctor | Contact | 18511440808 | yuanfuzhen2016@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiakuo Yu, Doctor | Peking University Third Hospital | Study Chair |
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| OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| The Affiliated Hospital Of Guizhou Medical University | OTHER |
| Jining Medical University | OTHER |
| Northern Jiangsu People's Hospital | OTHER |
| Inner Mongolia People's Hospital | OTHER |
| Shenzhen Pingle Orthopedic Hospital | OTHER |
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| Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA) | Procedure | Patients in the control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA). |
|
Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis,180° is normal. The more deviated from 180°, the worse. |
| 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. | 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. | 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. | 12 months after operation |
| during surgery |
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | Before operation |
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | 5 days after operation |
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | 6 months after operation |
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | 12 months after operation |
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | Before operation |
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | 5 days after operation |
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | 6 months after operation |
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | 12 months after operation |
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | Before operation |
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | 5 days after operation |
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | 6 months after operation |
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | 12 months after operation |
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | Before operation |
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | 5 days after operation |
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | 6 months after operation |
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | 12 months after operation |
| ID | Term |
|---|---|
| D003075 | Coitus |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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