Therapeutic Effects of Autologous Adipose Tissue-Derived Stromal Vascular Fraction (ADSVF) Implantation for Non-traumatic Osteonecrosis of the Femoral Head: A Double-Blind Randomized Clinical Study with or without ADSVF.
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0009312
- Lead Sponsor
- Hyundae Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
Subjects with non-traumatic femoral head avascular necrosis who consent to this study
- Subjects who have not received other treatments such as core decompression and multiple trepanation for avascular necrosis of the femoral head in the relevant area
- Before the femoral head collapses or when the depth of collapse is less than 2 mm
- Subjects with more than 30% necrosis of the femoral head
- Subjects with a depth of femoral head collapse of 2 mm or more
- Subjects with more than 30% necrosis of the femoral head
- Subjects who have received treatment of core decompression and multiple trepanation for avascular necrosis of the femoral head in the relevant area
- Subjects taking osteoporosis treatments such as bisphosphonates or parathyroid hormones
- Subjects who are taking immunosuppressants or cytotoxic agents or who need to take them during the test period
- Subjects who must continuously take corticosteroids for treatment purposes
- Subjects who are unable to undergo MRI (magnetic resonance imaging) due to artificial pacemakers, metallic hip joints, prosthetics, etc.
- Subjects who are pregnant or breastfeeding
- Subjects currently suffering from infectious diseases including HIV and hepatitis
- Subjects with serious diseases that may affect this clinical trial: cardiovascular disease, tumor, kidney disease, endocrine disease such as decreased bone metabolism, increased bone metabolism and thyroid disease, autoimmune disease, etc.
- Subjects who participated in another clinical trial within 3 months of participating in this clinical trial
- In other cases where the researcher determines that participation in this study is inappropriate
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Conversion rate to Total hip treplacement
- Secondary Outcome Measures
Name Time Method 1. To find out whether osteonecrotic lesions in the femoral head change and decrease in size or disappear. 2. Harris Hip Score , The Western Ontario and McMaster Universities Arthritis Index, University of California Los Angeles Score