severe knee diseases
Conditions
Interventions
Group 1 :Attune cementless knee joint
Group 2:Attune cemented knee joint
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
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 <= 35kg / m2; 4. Those patients whose bones are mature, whose health condition is stable according to physical examination and medical history, who can perform surgery and participate in subsequent test items, and who can follow up after operation; 5. Patients who received total knee arthroplasty 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. The subjects were pregnant women 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 in this study; 5. Subjects who had undergone partial knee replacement (single condyle, double condyle or patellofemoral joint replacement), patellar resection, high tibial osteotomy or first TKA treatment before the affected knee; 6. Patients with advanced tumor, bad fluid, alcohol or drug addiction and / or mental illness, which may affect their participation in the study, according to the researchers; 7. Patients with severe osteoporosis, metabolic osteopathy, radiation osteopathy or tumor around the knee joint, leading to the researcher's opinion 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. Patients with physical diseases that may lead to life expectancy 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 known to be allergic to any implant component (e.g., metal); 14. Subjects with hemoglobin < 110 g / L; 15. 90% of subjects with albumin < normal low limit; 16. Subjects with C-reactive protein (CRP) more than 2 times higher than the normal limit; 17. Subjects with ESR more than 2 times higher than normal; 18. The subjects with abnormal coagulation function cannot be corrected or replaced; 19. Other researchers think it is not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KSS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC score;FJS-12 score;radiographic data;adverse event; | — |
Countries
China
Contacts
Public ContactWei Chai
Chinese PLA General Hospital
Outcome results
None listed