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

Yuanchen Ma, Tao Wang, Junxing Liao, Honglin Gu, Xinpeng Lin, Qing Jiang, Max K Bulsara, Minghao Zheng, Qiujian Zheng, Yuanchen Ma, Tao Wang, Junxing Liao, Honglin Gu, Xinpeng Lin, Qing Jiang, Max K Bulsara, Minghao Zheng, Qiujian Zheng

Abstract

Introduction: 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.

Conclusion: Implantation of the autologous BBC grafting combined with core decompression is effective to prevent further progression for the early stages of ANFH.

Trial registration: ClinicalTrials.gov identifier NCT01613612. Registered 13 December 2011.

Figures

Figure 1
Figure 1
Image of operation procedure. (A) Radiography of the femoral head at the time of the operation. The Kirschner wire and 10-mm diameter trephine were driven into the mid-line of the trochanter by a cannulated drill under C-arm x-ray guidance toward the necrotic area. (B) A 3.5-cm long cylindrical bone was taken from the trochanter through the trephine and used for bone graft to enriched bone marrow incorporation.
Figure 2
Figure 2
Flow chart of patient enrollment and randomization.
Figure 3
Figure 3
A comparison between the control group and bone-marrow buffy coat (BBC) group of the visual analogue scale (A), the Lequesne index (B) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score (C) at the pre-operation, 3 months post-operation, and 24 months post-operation. The results were present as mean ± standard error of the mean. Asterisk (*) indicated a significant difference compared with the baseline; pound sign (#) indicated a significant difference compared with the control group.
Figure 4
Figure 4
Long-term follow-up of disease progression. (A) Rate of progression for the control group and bone-marrow buffy coat (BBC) group of different stage avascular necrosis of femoral head (ANFH) at 3 months’ and 24 months’ follow-up. (B) Cumulative percentage of different Ficat stages of hip in the control and BBC group at pre-operation, 3 months post-operation, and 24 months post-operation.

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