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

Phase 2

• Conditions: Avascular Necrosis of Femur Head
• Interventions: Procedure: core decompression; Procedure: Enriched BMCs implantation combined with core decompression

• Registration Number: NCT01613612
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-07
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Last Update Submitted: 2012-08-12
• Last Update Posted: 2012-08-14
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group:core decompression	core decompression	single core decompression
Treatment group: BMCs+core decompression	Enriched BMCs implantation combined with core decompression	Enriched bone marrow cells combined with core decompression

Primary Outcome Measures

Name	Time	Method
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