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

NCT01613612 | Unknown Phase 2

• 1 other identifier: GGH_201112_Ortho_1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Avascular Necrosis of Femur Head

Outcome Measures

Primary Outcomes (3)

• change of Visual Analogue Scale

  Change from baseline in 24 months

  before invention and 24 months after invention

• change of lequensne algofunctional index

  change from baseline in 24 months

  before invention and 24 months after invention

• change of WOMAC index

  change from baseline in 24 months

  before invention and 24 months after invention

Study Arms (2)

control group:core decompression

SHAM COMPARATOR

single core decompression

Procedure: core decompression

Treatment group: BMCs+core decompression

ACTIVE COMPARATOR

Enriched bone marrow cells combined with core decompression

Procedure: Enriched BMCs implantation combined with core decompression

Interventions

core decompression PROCEDURE

minimal surgical invention to drill a core to the femoral head to release pressure

control group:core decompression

Enriched BMCs implantation combined with core decompression PROCEDURE

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.

Treatment group: BMCs+core decompression

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• femoral head necrosis patients
• stage I/II/III (Ficat)
• age from 18 to 55 years
• stop steroid treatment for minimal 6 months

You may not qualify if:

• age younger than 18 or older than 55
• any hemopathy
• tumor
• femoral head/neck fracture

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Related Publications (2)

• Li M, Ma Y, Fu G, Zhang R, Li Q, Deng Z, Zheng M, Zheng Q. 10-year follow-up results of the prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of the femoral head. Stem Cell Res Ther. 2020 Jul 16;11(1):287. doi: 10.1186/s13287-020-01810-8.

  PMID: 32678055 DERIVED

• Ma Y, Wang T, Liao J, Gu H, Lin X, Jiang Q, Bulsara MK, Zheng M, Zheng Q. Efficacy of autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of femoral head: a prospective, double-blinded, randomized, controlled study. Stem Cell Res Ther. 2014 Oct 14;5(5):115. doi: 10.1186/scrt505.

  PMID: 25315149 DERIVED

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Orthopaedic Surgery

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: June 7, 2012
• Study Start: March 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 14, 2012

Record last verified: 2012-08