Osteonecrosis of the femoral head Musculoskeletal Diseases Osteonecrosis
Conditions
Interventions
The initial protocol intends to recruit 60 patients. Patients are randomly divided into three groups with 20 patients in group I who receive 2000 impulses of ESWT at 24 Kv
20 patients in group II who receive 4000 impulses of ESWT at 24 Kv and 20 patients in group III who receive 6000 impulses of ESWT at 24 Kv.
Sponsors
Chang Gung Medical Foundation (Taiwan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over 18 years old 2. ONFH in stage I, stage II or stage III-a according to ARCO classification at initial presentation
Exclusion criteria
Exclusion criteria: 1. Patients with late stages of the disease (stages III-b, III-c or stage IV) 2. Patients under 18 years of age 3. Patients with cardiac arrhythmia or pacemaker 4. Patients on immunosuppressant drugs 5. Patients with infection or advanced arthritis 6. Patients with coagulopathy 7. Chronic renal failure 8. Pregnancy 9. Poor compliant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number of total hip arthroplasty (THA) performed during the study period (1 year) 2. Pain (VAS) score and Harris hip score 3. Changes on X-ray and MRI studies | — |
Secondary
| Measure | Time frame |
|---|---|
| Ten milliliters of peripheral blood are obtained for measurements of serum NO level, VEGF and TGF-a; BMP-2, osteocalcin, DKK-1, IGF and IL-6 before treatment and at 1, 3, 6 and 12 months after treatment. | — |
Countries
Taiwan
Outcome results
None listed