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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Qiujiang Zheng, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01613612
First received: December 13, 2011
Last updated: August 12, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Avascular Necrosis of Femur Head
 Procedure: core decompression
Procedure: Enriched BMCs implantation combined with core decompression
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • change of Visual Analogue Scale [ Time Frame: before invention and 24 months after invention ] [ Designated as safety issue: No ]
    Change from baseline in 24 months

  • change of lequensne algofunctional index [ Time Frame: before invention and 24 months after invention ] [ Designated as safety issue: No ]
    change from baseline in 24 months

  • change of WOMAC index [ Time Frame: before invention and 24 months after invention ] [ Designated as safety issue: No ]
    change from baseline in 24 months


Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Qiujiang Zheng, Director of Orthopaedic Surgery, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01613612     History of Changes
Other Study ID Numbers: GGH_201112_Ortho_1
Study First Received: December 13, 2011
Last Updated: August 12, 2012
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on June 13, 2013