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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01613612
Other study ID # GGH_201112_Ortho_1
Secondary ID
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received December 13, 2011
Last updated August 12, 2012
Start date March 2009
Est. completion date December 2012

Study information

Verified date August 2012
Source Guangdong General Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Procedure:
core decompression
minimal surgical invention to drill a core to the femoral head to release pressure
Enriched 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Guangdong General Hospital

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT01605383 - Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head Phase 1/Phase 2