Hip disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subjects aged 18-75 years; 2. The subject should have indications for total hip replacement surgery; 3. The affected limb on the test side received total hip replacement for the first time; 4. Before surgery, subjects were willing and able to sign informed consent, and the process of obtaining informed consent should comply with GCP regulations.
Exclusion criteria
Exclusion criteria: 1. Subject's neuromuscular insufficiency (e.g., paralysis, myolysis, or abductor weakness) resulting in hip instability or gait abnormalities after surgery; 2. The subject is mentally incapable or unable to understand the requirements of participating in the study; 3. Alcoholics or drug addicts, drug abusers; 4. Obese BMI > 35; 5. Poor diabetes control (fasting blood glucose still >=8.0mmol/L after drug control); 6. Severe liver and kidney insufficiency; 7. The subject is known to have a history of allergy to one or more implanted materials; 8. Active infection of the hip joint or other parts of the body; 9. Severe osteoporosis, metabolic bone disease, radiation bone disease and tumor around the hip joint; 10. Pregnant or lactating subjects or subjects who plan to become pregnant within 12 months; 11. Systemic diseases (including coagulopathy, severe heart disease, severe respiratory disease, and others who cannot tolerate anesthesia or surgery); The life expectancy of patients who are weak or cannot tolerate surgery due to other diseases is less than 2 years; 12. Subjects who have participated in clinical studies of other drugs, biologics or medical devices before enrollment and have not reached the primary study endpoint time limit; 13. Other diseases of the subjects limited their participation in the study and their compliance with follow-up, which affected the scientific integrity of the study; 14. The subjects do not cooperate with or are not conducive to the treatment and postoperative rehabilitation exercise, and the compliance is expected to be poor; 15. Other investigators did not consider the situation appropriate for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The matching rate between the preoperative plan and the actual outcome of the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay;Hospitalization cost;The incidence of postoperative complications; | — |
Countries
China
Contacts
Jiangsu Provincial Hospital of Chinese Medicine