Osteoarthritis of knee
Conditions
Interventions
Cementless group:Cementless TKA
Cemented group:Cement TKA
Sponsors
Orthopedic Department of Chinese PLA General Hospital
Eligibility
Sex/Gender
Male
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with indications of total knee replacement and ineffective conservative treatment; 2. Adults >= 45 years old; 3. Patients with BMI <= 35; 4. The patients with mature bone, according to the physical examination and medical history, show stable health, can carry out surgery and participate in the subsequent test items, and can follow up the postoperative follow-up; 5. The subjects' knee joints were those who received total knee replacement for the first time; 6. Patients who have not participated in other clinical trials for 12 months before participating in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Subjects who are unable to provide written consent for voluntary participation in clinical research; 2. Pregnant or lactating women; 3. Subjects who are expected to undergo contralateral knee replacement within 12 months after the first operation; 4. The contralateral knee joint has been selected for the study; 5. Patients who received partial knee replacement (single condyle, double condyle or patellofemoral joint replacement), patellar resection, high tibial osteotomy or the first TKA treatment before the knee; 6. Patients with advanced cancer, cachexia, alcoholism or drug addiction and / or mental illness that the researchers believe may affect their participation in this study; 7. Patients with severe osteoporosis, metabolic osteopathy, radiation osteopathy or tumor around the knee joint lead the researchers to think that the above conditions have a negative impact on implant fixation and the results of this study; 8. Patients with major neurological or musculoskeletal diseases or diseases that may have adverse effects on gait or weight-bearing (such as muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot disease); 9. Patients who can't talk, read and understand the questions freely and can't complete the "subject subjective questionnaire"; 10. Subjects with physical diseases that may lead to a life expectancy of less than 2 years; 11. Subjects with diseases that restrict their participation in the study, fail to comply with follow-up requirements or affect the scientific integrity of the study; 12. Subjects who are currently participating in another trial drug or device study; 13. Subjects allergic to any implant component (e.g., metal); 14. Subjects with hemoglobin < 11 g / L; 15. 90% of subjects with albumin < normal low limit; 16. C-reactive protein (CRP) was more than 2 times higher than normal; 17. Subjects with ESR more than 2 times higher than normal; 18. Subjects with abnormal coagulation function and unable to be corrected or replaced; 19. Other researchers think it is not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KSS Knee Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| KSS Functional Score;Oxford Knee Score;SF-12;WOMAC Index;Radiological Evaluation;Survival rate; | — |
Countries
China
Contacts
Public ContactChai Wei
Chinese PLA General Hospital
Outcome results
None listed