diseases of knee joints
Conditions
Interventions
artificial intelligence group:to accomplish the operation by referencing preoperative plan produced by AI KNEE
conventional group:to accomplish the operation by referencing preoperative templating
conventional group:to accomplish the operation using traditional instruments
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subject should have indications for total knee replacement, and conservative treatment is ineffective; 2. Aged >=45 years; 3. The BMI of subject should be less than 35; 4. Subject should be qualified to undergo the surgery and participate in the subsequent follow-up and the bone of the subject should be mature; 5. Subject is a suitable candidate for primary total knee replacement; 6. Subject should not be the participant in any other clinical trial in the past 12 months prior to this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Subject is unwilling to participate in the clinical study voluntarily; 2. Subject is pregnant or lactating women; 3. Subject is expected to undergo contralateral knee replacement within 12 months after the first operation; 4. The contralateral knee joint of the subject has been enrolled in this study; 5. Subject has received partial knee replacement (single condyle, double condyle or patellofemoral joint replacement), patellotomy, high tibial osteotomy or primary TKA treatment; 6. Subject has advanced tumor, dysuria, alcoholism or drug addiction and/or mental illness, which the researcher thinks may affect his/her participation; 7. Subject has severe osteoporosis, metabolic bone disease, radioactive bone disease or tumors around the knee joint, which may cause a negative impact on implant fixation and the results of this study; 8. Subject has a neurological disease or musculoskeletal disease or a disease that may adversely affect gait or load-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot disease); 9. Subject was unable to converse, read, understand the questions or to complete the "subjective questionnaire"; 10. Subject with diseases which could lead to life expectancy less than 2 years; 11. Subject is unable to comply with follow-up requirement; 12. Subject is currently attending another trial; 13. Subject is allergic to the implant components (metal, for example); 14. Hemoglobin < 11 g/L; 15. Albumin < 90% of the normal lower limit; 16. C-reactive protein (CRP) in more than 2 times than the normal range; 17. Erythrocyte sedimentation rate (ESR) in more than 2 times than the normal range; 18. Coagulant function abnormality; 19. Other kind of situation that is unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| component size; | — |
Secondary
| Measure | Time frame |
|---|---|
| posterior condylar angle;femoral valgus angle;the angle of tibial component; | — |
Countries
China
Contacts
Public ContactChai Wei
Chinese PLA General Hospital
Outcome results
None listed