Osteonecrosis of the Femoral Head
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meet the above diagnostic criteria for femoral head necrosis and the femoral head has collapsed (ARCOIII-IV stage);Diagnostic criteria: refer to the international diagnostic criteria proposed by Mont et al 1) Specificity criteria 1. Collapse of the femoral head 2 X-rays of subcartilage linear translucent opacity 3 anterolateral dead bones 4 ECT shows a radioactive increase band surrounding the hyporadiation-low zone 5 MRI T2-weighted phase bilinear sign 6. Bone biopsy: Bone pit is empty 2) Non-specific criteria 1. Collapse of the femoral head with narrowing of the joint space 2. Speckled cystic changes and osteosclerosis in the femoral head are mixed 3. Increased bone scanning activity 4 MRI showed bone marrow edema 5. Pain when the hip joint is moved but the X-ray is normal 6. History of alcohol consumption or hormone use 7. Bone biopsy bone marrow edema or fibrosis As long as one of the specific and nonspecific indicators is satisfied the diagnosis is established. 2) Patients with no obvious pain or less severe pain (VAS score =3 points) combined with limited hip mobility; 3)Age 18-75 male or female 4)Imaging showed that the necrotic area was well repaired the anterior or lateral wall of the femoral head was preserved the relationship between the femoral head and the acetabulum was matched and there was no subluxation of the femoral head. 5) Volunteer to participate in this study and agree to sign ethical informed consent.
Exclusion criteria
Exclusion criteria: 1) Imaging indicated that the necrotic area involved the anterior lateral wall of the femoral head and the risk of further collapse of the femoral head was high; 2)Patients with severe cardiovascular cerebrovascular hematopoietic and other primary diseases especially those with abnormal coagulation function are not suitable for needle-knife treatment; 3) Patients with joint infection or other diseases especially patients with skin damage and ulceration at the acupotomy site; 4) Pregnant and lactating women; 5) Participants participating in other clinical studies or receiving other related treatments within 30 days prior to enrollment which may affect the efficacy observation indicators of this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris hip function Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hip effusion score;Serum inflammatory factors (IL-6 IL-1ß TNF-a);vasomotor factors (NO ET-1 NE HIS);Total score of TCM clinical efficacy evaluation of femoral head necrosis;Improved Ashworth score;9/5000 Classification of femoral head bone marrow edema;The short-form 36 item health survey questionnaire; | — |
Countries
China
Contacts
Wangjing Hospital of China Academy of Chinese Medical Sciences