severe hip diseases
Conditions
Interventions
the Actis group:Acits femoral stem
Tri-lock group:Tri-lock femoral stem
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The age of the subjects is 18-75 years old; 2. The skeleton of the subject is mature; 3. Subjects should have indications for total hip arthroplasty; 4. The affected limb of the subject side is the first time for total hip arthroplasty; 5. Prior to surgery, subjects are willing and able to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Neuromuscular insufficiency (e.g., paralysis, myolysis or abductor weakness) will lead to hip instability or abnormal gait after surgery. 2. The subjects are mentally incapable or unable to understand the requirements of participating in the study; 3. Alcoholics or drug addicts, drug abusers; 4. Obesity, BMI > 35kg/m2; 5. Poor diabetes control (fasting blood glucose under drug control is still >= 8.0mmol/L); 6. Severe liver and kidney insufficiency; 7. The subject is known to have a history of allergy to one or more of the implanted materials; 8. Active infections of the hip joint or other parts of the body; 9. There are severe osteoporosis, metabolic bone disease, radioactive bone disease or tumor around the hip joint. 10. Women who are pregnant or nursing or who plan to pregnant within 12 months; 11. Systemic diseases (including blood coagulation dysfunction, serious heart disease, severe respiratory disease, other can't tolerate anesthesia or surgery). Patients who are physically weak or cannot tolerate surgery due to other systemic diseases, life expectancy is less than 2 years; 12. Subjects were previously included in other drugs, biologics, or medical devices clinical studies and have not reached the main research endpoint; 13. Subject with other diseases to limit its participating in the study, failure to complete follow-up, impact the scientific integrity of the study; 14. Subjects noncompliance or not conducive to treatment and postoperative rehabilitation exercise, expecting to poor adherence; 15. Subject who had a history of hip surgery; 16. Other situations are thought unsuitable for this clinical trial by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris hip score; | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC score;FJS-12 score;radiographic data; | — |
Countries
China
Contacts
Public ContactWei Chai
Chinese PLA General Hospital
Outcome results
None listed