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| Name | Class |
|---|---|
| Inner Mongolia People's Hospital | OTHER |
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This study aims to evaluate the safety and effectiveness of the femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis of the personalized total knee replacement system; to verify the clinical feasibility and safety of the personalized surgical guide, as a personalized total knee replacement The clinical application of the prosthesis and its guide lays the foundation, including:
2.1 Evaluate the advantages of personalized total knee replacement surgery in osteotomy methods, evaluate the impact of anatomical osteotomy methods on intraoperative and postoperative effects and early and long-term clinical effects.
2.2 By measuring the amount of osteotomy in personalized total knee replacement surgery, evaluate the impact of a smaller and reasonable amount of osteotomy on the patient's early and long-term clinical results.
2.3 Verify the clinical effect of personalized total knee replacement prosthesis, and provide the basis for its clinical promotion and application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D printed personalized TKA prosthesis | Experimental | Patients in the experimental group received 3D printed personalized TKA prosthesis treatment |
|
| Zimmer NexGen TKA prostheses | Active Comparator | Patients in the active comparator group received Zimmer NexGen TKA prostheses treatment |
|
| 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 | The size of the osteotomy | during surgery |
| Operation time | Operation time | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | 7 days,3months, 6 months and 12 months postoperatively |
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. |
Inclusion Criteria:
Exclusion Criteria:
(1) Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥95mmHg), congestive heart failure (New York Heart Association status classification III or IV); (2) Subjects whose serum creatinine level exceeds 2.0 mg/dl (176.8 μmol/L); (3) Total white blood cell (WBC) count at screening <2500/μL, or platelet <100000/μL or neutrophil <1500/μL or hemoglobin <8.5 g/dL; (4) Within six months before the baseline, there is a history of alcohol or drug abuse or evidence of ongoing abuse.
16) The patient is mentally incapable or unable to understand the requirements for participating in the research.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fu-zhen Yuan | Contact | 18511440808 | yuanfuzhen2016@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia-kuo Yu, Prof. | Peking University Third Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Sports Medicine, Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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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 |
|
| 7 days,3months, 6 months and 12 months postoperatively |
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | 7 days,3months, 6 months and 12 months postoperatively |
| D012216 |
| Rheumatic Diseases |