None listed
Conditions
Interventions
Group 1:OR3O double action hip system
Group 2:Total hip system with traditional single articular surface design
Sponsors
The First Affiliated Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subjects were judged to be suitable for primary total hip replacement with OR3O double action hip system or conventional single articular surface design total hip system; 2. The investigator judged that the subjects' bones were mature; 3. Aged between 18 and 80 years (inclusive); 4. The affected hip underwent total hip replacement for the first time; 5. The subject has any of the following indications: (1) Late hip degeneration due to degenerative, post-traumatic, or rheumatoid arthritis; (2) Femoral head fracture or ischemic necrosis; (3) Various types of osteoarthritis; (4) Risk of hip dislocation; (5) Fracture of femoral neck or proximal hip joint; 6. Subject agrees to sign an informed consent approved by the Ethics Committee (EC) prior to any study procedure (including preoperative data review and/or data collection for electronic case report forms); 7. The subject is willing and able to attend the required follow-up visit and complete the study activities; 8. Subjects' preoperative HHS score <= 79 (classified as medium or poor).
Exclusion criteria
Exclusion criteria: 1. Subject with hip dysplasia, CROWE III or IV; 2. The subject is physically weak or unable to undergo surgery due to other medical conditions; 3. Subjects have diseases that may affect survival rate or outcome of THA; 4. The subjects' life expectancy is less than 2 years; 5. The subject suffers from a mental or neurological disorder that impedes his ability or willingness to restrict activities that pose a risk to the affected limb; 6. The subject's physical conditions or activities may impose extreme load on the implant, such as Charcot's joint disease, muscle defects, multiple joint dysfunction, etc.; 7. Have neuromuscular dysfunction (paralysis, myolysis, and abductor weakness) resulting in hip instability or gait abnormalities after surgery; 8. The subject has a mental or neurological condition that prevents or discourages participation in the study, including mental illness, mental retardation, drug or alcohol abuse; 9. Active infection of the whole body or the site of the planned operation; 10. Body Mass index (BMI) >=40.0 kg/m^2; 11. Known allergy to any instrument component used in the test; 12. Pregnant or lactating subjects; 13. Participate in another investigational drug, biological or device trial during the 30-day active trial participation period; 14. Poor compliance of subjects; 15. The subject is limited to participate in the clinical trial due to complications of other diseases, unable to participate in follow-up, or may affect the scientific integrity; 16. Preoperative HHS score of subjects >= 80 points (good or excellent classification); 17. The investigator believes that the subjects have other medical conditions or conditions that are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris Hip Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| European Five-dimensional Health Scale;Hip Disability and Osteoarthritis Outcome Score;Radiographic Analysis; | — |
Countries
China
Contacts
Public ContactCao Li
Outcome results
None listed