Avascular Necrosis of Femur Head Clinical Trial
Official title:
Control Study of Implantation of Enriched Bone Marrow Cells for the Treatment of Avascular Necrosis of Femoral Head
Verified date | August 2012 |
Source | Guangdong General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell implantation combined with core decompression to single core decompression for the treatment of avascular necrosis of femoral head.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | December 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - femoral head necrosis patients - stage I/II/III (Ficat) - age from 18 to 55 years - stop steroid treatment for minimal 6 months Exclusion Criteria: - age younger than 18 or older than 55 - any hemopathy - tumor - femoral head/neck fracture |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Guangdong General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of Visual Analogue Scale | Change from baseline in 24 months | before invention and 24 months after invention | No |
Primary | change of lequensne algofunctional index | change from baseline in 24 months | before invention and 24 months after invention | No |
Primary | change of WOMAC index | change from baseline in 24 months | before invention and 24 months after invention | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01605383 -
Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head
|
Phase 1/Phase 2 |