Bone diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged from 18 to 80 years old (including 18 and 80 years old), regardless of gender; 2. Patients should have indications for hip replacement surgery; 3. Patients are willing to participate in clinical trials and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with neuromuscular insufficiency (e.g., paralysis, myolysis, or abductor weakness) that would result in postoperative hip instability or abnormal gait; 2. Active infection of the hip or other body parts; 3. Patients with severe hip deformity or CROWE grade 3 or 4 developmental dysplasia of the hip; 4. Patients with ankylosing spondylitis with bony ankylosis or severe stiffness; 5. Patients undergoing bilateral hip arthroplasty at the same time, or patients with contralateral hip arthroplasty within 3 months, or patients with contralateral hip arthroplasty expected within 1 year after surgery; 6. The patient is known to be allergic to one or more implant materials; 7. Patients with severe medical or surgical diseases or weak constitution who cannot tolerate surgery; 8. Patients with predicted poor compliance; 9. Pregnant or lactating women or patients who plan to have a child during the trial; 10. Patients were enrolled or were enrolled in a drug clinical trial within 3 months before enrollment or in a clinical trial of another device within 1 month before enrollment; 11. Other circumstances considered by the investigator to be inappropriate for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plan accuracy in component size;Cup inclination/anteversion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of acetabular cup position in safe zone;Leg length discrepancy;Operation time;Functional outcome;Blood Loss;Inflammation indicators;Complications; | — |
Countries
China
Contacts
The Fourth Medical Center of Chinese PLA General Hospital