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

IntroductionAvascular 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.MethodsA 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.ResultsAt 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.ConclusionImplantation of the autologous BBC grafting combined with core decompression is effective to prevent further progression for the early stages of ANFH.Trial registrationClinicalTrials.gov identifier NCT01613612. Registered 13 December 2011.

The role of “cell therapy” in osteonecrosis of the femoral head

“…Ma et al (2014) reported a statistically significant improvement (p < 0.001) in the cell therapy group at final follow-up compared to the baseline situation, with respect to the level of pain and joint symptoms.…”

“…3 of the studies were randomized control trials (RCTs) (Sen et al 2012, Zhao et al 2012, Ma et al 2014), 1 was a prospective control study (Gangji et al 2011), and the remaining 3 were retrospective case-control studies (Yamasaki et al 2010, Lim et al 2013, Liu et al 2013). …”

“…6 studies (with 421 participants) provided relevant data (Yamasaki et al 2010, Gangji et al 2011, Zhao et al 2012, Lim et al 2013, Liu et al 2013, Ma et al 2014). The pooled estimate of effect size for structural failure of the FH favored the cell therapy group, as, in this treatment group, the odds of progression of the femoral head to the collapse stage were shown to be decreased by 5 times compared to the control (CD) group (OR = 0.2, 95% CI: 0.08–0.6; p = 0.02).…”

“…4 studies provided relevant data, but not in a consistent way to allow us to obtain a summarized estimate of effect size of any functional outcome (Gangji et al 2011, Sen et al 2012, Liu et al 2013, Ma et al 2014). …”

“…Relevant data were obtained from 5 studies (with 252 participants) (Yamasaki et al 2010, Gangji et al 2011, Zhao et al 2012, Liu et al 2013, Ma et al 2014). The pooled estimate of effect size for structural failure of FH indicated an 8-fold decrease in the odds of collapse of the FH in the cell therapy group compared to the CD group (OR = 0.12, 95% CI: 0.06–0.26; p < 0.001) in the absence of statistical heterogeneity (Q-test = 1.81, df = 4, p = 0.77, and I 2 = 0%) (Figure 6A, see Supplementary data).…”