Avascular necrosis of the femoral head
Conditions
Interventions
Experimental group:Surgical treatment included robot-assisted core decompression and impacting bone grafting
Sponsors
Xijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must meet all of the following criteria to be eligible for this study; 2. Femoral head necrosis staged as Stage II or III according to the Chinese classification; if both femoral heads are affected, they are counted as two cases; 3. The cause is alcoholic, steroid-induced, or traumatic femoral head necrosis; 4. Subjects aged 18-50 years (inclusive), regardless of gender; 5. Signed informed consent (or signed by a legal guardian), indicating that they understand the purpose of this study and the procedures required, and are willing to participate.
Exclusion criteria
Exclusion criteria: 1. Advanced femoral head necrosis (Stage IV in the Chinese classification) or traumatic femoral head necrosis; 2. Bone tumors, ankylosing spondylitis, rheumatoid arthritis, flat hip, osteoarthritis; 3. Presence of uncontrolled acute or chronic infections systemically or locally; 4. Patients with uncontrolled diabetes (HbA1c >= 8.0% and fasting blood glucose GLU >= 7.0 mmol/L); 5. Patients with uncontrolled severe anemia (HGB = 20 mg/day or 4 tablets/person) and cannot discontinue them; 8. Abnormal liver or kidney function (e.g., ALT, AST exceeding twice the upper limit of normal, Cr exceeding twice the normal value and deemed clinically significant by the investigator); 9. Participants with other organ malignancies or other severe systemic diseases; 10. History of allergy to the test product or control product ingredients, or individuals with a tendency to allergies; 11. Positive pregnancy test, pregnant or breastfeeding women, or those with recent plans for pregnancy; 12. Participants unable to take reliable contraceptive measures during the trial; 13. Participation in other drug, biological, or medical device clinical trials within the past 3 months; 14. Individuals with consciousness disorders or psychiatric diseases who cannot perform self-assessment; 15. Other situations deemed by the investigator as unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris Hip Score (HHS);Karnofsky Score(KPS);VAS Score;C-reactive protein;Liver and kidney function electrolytes; | — |
Countries
China
Contacts
Public ContactZhen Wang
Xijing Hospital
Outcome results
None listed