Treatment of early stage osteonecrosis of the femoral head with implantation of autologous bone marrow-derived and cultured mesenchymal stem cells
Completed
- Conditions
- Osteonecrosis of the femoral head at early stageMusculoskeletal DiseasesOsteonecrosis
- Registration Number
- ISRCTN18167626
- Lead Sponsor
- Dalian University Zhongshan Hospital (China)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. Aged between 18 to 45 years, either sex
2. Patients with hips at stages IC to IIC according to Association Research Circulation Osseous (ARCO) classification
3. Etiological factors including trauma, alcohol abuse, corticosteroid use, Caisson disease, hyperlipidemia, and idiopathic
Exclusion Criteria
1. Pregnancy
2. Current and previous infection
3. Skeletal immaturity
4. Immunosuppressive drug therapy
5. A history of inflammatory arthritis
6. Evidence of cardiovascular diseases
7. Prior systemic corticosteroid treatment
8. Mental health problems preventing adequate follow-up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcome, assessed by the Harris Hip Score, measured pre-operatively and at 3 months, 6 months, 12 months, 30 months, and every 2 years post-operatively thereafter
- Secondary Outcome Measures
Name Time Method Radiographic approaches are used to determine the progress in osteonecrotic stage and to assess the volume of the necrotic lesion in the femoral head, measured pre-operatively and at 3 months, 6 months, 12 months, 30 months, and every 2 years post-operatively thereafter