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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01613612
Recruitment Status : Unknown
Verified August 2012 by Qiujiang Zheng, Guangdong General Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : June 7, 2012
Last Update Posted : August 14, 2012
Information provided by (Responsible Party):
Qiujiang Zheng, Guangdong General 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.

Condition or disease Intervention/treatment Phase
Avascular Necrosis of Femur Head Procedure: core decompression Procedure: Enriched BMCs implantation combined with core decompression Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Control Study of Implantation of Enriched Bone Marrow Cells for the Treatment of Avascular Necrosis of Femoral Head
Study Start Date : March 2009
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Sham Comparator: control group:core decompression
single core decompression
Procedure: core decompression
minimal surgical invention to drill a core to the femoral head to release pressure

Active Comparator: Treatment group: BMCs+core decompression
Enriched bone marrow cells combined with core decompression
Procedure: 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.

Primary Outcome Measures :
  1. change of Visual Analogue Scale [ Time Frame: before invention and 24 months after invention ]
    Change from baseline in 24 months

  2. change of lequensne algofunctional index [ Time Frame: before invention and 24 months after invention ]
    change from baseline in 24 months

  3. change of WOMAC index [ Time Frame: before invention and 24 months after invention ]
    change from baseline in 24 months

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Qiujiang Zheng, Director of Orthopaedic Surgery, Guangdong General Hospital Identifier: NCT01613612     History of Changes
Other Study ID Numbers: GGH_201112_Ortho_1
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: August 14, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Femur Head Necrosis
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases