Implantation of Bone Marrow Cells to Treat Avascular Necrosis of Femoral Head (ANFH)

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01613612
• Other study ID #: GGH_201112_Ortho_1
• 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

Related Conditions & MeSH terms

• Avascular Necrosis of Femur Head
• Femur Head Necrosis
• Necrosis
• Osteonecrosis

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