Avascular Necrosis of Femur Head
Conditions
Brief summary
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.
Interventions
PROCEDUREcore decompression
minimal surgical invention to drill a core to the femoral head to release pressure
PROCEDUREEnriched BMCs implantation combined with core decompression
Patients are subjected to bone marrow aspiration from the anterior iliac crest. Mononuclear cells are enriched from patients' bone marrow by centrifuge, which are grafted with autologous cortical bone and implanted to the necrotic zone of the femoral head.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of Visual Analogue Scale | before invention and 24 months after invention | Change from baseline in 24 months |
| change of lequensne algofunctional index | before invention and 24 months after invention | change from baseline in 24 months |
| change of WOMAC index | before invention and 24 months after invention | change from baseline in 24 months |
Outcome results
None listed