Hip Joint Diseases
Conditions
Interventions
the test group:NA
Sponsors
Shanghai KETAI Medical Device Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subjects who are willing to participate in this study, and sign up the informed consent; 2. Aged 18~80 years old; 3. The skeleton of the subject is mature; 4. The subjects with end-stage hip disease require hip replacement without implantation contraindications; 5. The heart, liver and kidney function well; 6. The subjects who have good adherence, willing and able to follow up on request.
Exclusion criteria
Exclusion criteria: 1. The subjects who are unwilling to participate in this study, and do not sign informed consent; 2. The subjects whoes neuromuscular dysfunction (e.g. Paralysis, rhabdomyolysis or abductor weakness) can result in unstable hip joints or abnormal gait; 3. alcoholics or drug addicts, drug abusers; 4. poor compliance, mental disorders and difficult coordination; 5. BMI>35; 6. The subject who has allergies to one or more implants; 7. The subject who has an active infection in the hip or other parts of the body; 8. The subject who has severe osteoporosis, metabolic bone disease, radioactive bone disease and tumor around the hip; 9. lactating women; 10. Crowe III to IV hip dysplasia; 11.there was evidence that subjects suffered from heart, liver, and kidney dysfunction, through direct questioning and physical examination; 12. The subjects who are frail or otherwise unable to tolerate surgery due to all other diseases of the body; 13. The subjects who were enrolled in another study and unable to comply with follow-up; 14. The subjects who had previously participated in clinical studies of other drugs, biologics, or medical devices and did not meet the time limit of the primary study endpoint; 15. For any reason, the researchers concluded that the subjects were unlikely to complete the study; 16. advanced cancer and other critical patients; 17. The subject who has mentally ill and serious heart disease; 18. Patients who fail to meet the criteria for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging evaluation of Anderson bone ingrowth;X-ray plain films; | — |
Countries
China
Contacts
Public ContactYixin Zhou
Beijing JiShuiTan Hospital
Outcome results
None listed