title: 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.
abstract: BACKGROUND
  Avascular necrosis of femoral head (ANFH) is a progressive disease that often leads to hip joint dysfunction and even disability in young patients. Although the standard treatment, which is core decompression, has the advantage of minimal invasion, the efficacy is variable. Recent studies have shown that implantation of bone marrow containing osteogenic precursors into necrotic lesion of ANFH may be promising for the treatment of ANFH.
  
  
  METHODS
  A prospective, double-blinded, randomized controlled trial was conducted to examine the effect of bone-marrow buffy coat (BBC) grafting combined with core decompression for the treatment of ANFH. Forty-five patients (53 hips) with Ficat stage I to III ANFH were recruited. The hips were allocated to the control group (core decompression + autologous bone graft) or treatment group (core decompression + autologous bone graft with BBC). Both patients and assessors were blinded to the treatment options. The clinical symptoms and disease progression were assessed as the primary and secondary outcomes.
  
  
  RESULTS
  At the final follow-up (24 months), there was a significant relief in pain (P <0.05) and clinical joint symptoms as measured by the Lequesne index (P <0.05) and Western Ontario and McMaster Universities Arthritis Index (P <0.05) in the treatment group. In addition, 33.3% of the hips in the control group have deteriorated to the next stage after 24 months post-procedure, whereas only 8% in the treatment group had further deterioration (P <0.05). More importantly, the non-progression rates for stage I/II hips were 100% in the treatment group and 66.7% in the control group.
  
  
  CONCLUSIONS
  Implantation of the autologous BBC grafting combined with core decompression is effective to prevent further progression for the early stages of ANFH.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT01613612. Registered 13 December 2011.
authors.forename: Yuanchen
authors.initials: Y
authors.lastname: Ma
authors.forename: Tao
authors.initials: T
authors.lastname: Wang
authors.forename: Junxing
authors.initials: J
authors.lastname: Liao
authors.forename: Honglin
authors.initials: H
authors.lastname: Gu
authors.forename: Xinpeng
authors.initials: X
authors.lastname: Lin
authors.forename: Qing
authors.initials: Q
authors.lastname: Jiang
authors.forename: Max K
authors.initials: MK
authors.lastname: Bulsara
authors.forename: Minghao
authors.initials: M
authors.lastname: Zheng
authors.forename: Qiujian
authors.initials: Q
authors.lastname: Zheng
mesh_terms: D000328:Adult; D016026:Bone Marrow Transplantation / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D005271:Femur Head Necrosis / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014182:Transplantation, Autologous; D016896:Treatment Outcome