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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.

Not Applicable
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
Inclusion Criteria

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

Exclusion Criteria

- 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
NameTimeMethod
Conversion rate to Total hip treplacement
Secondary Outcome Measures
NameTimeMethod
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
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