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

Mengyuan Li, Yuanchen Ma, Guangtao Fu, Ruiying Zhang, Qingtian Li, Zhantao Deng, Minghao Zheng, Qiujian Zheng, Mengyuan Li, Yuanchen Ma, Guangtao Fu, Ruiying Zhang, Qingtian Li, Zhantao Deng, Minghao Zheng, Qiujian Zheng

Abstract

Background: Avascular necrosis of the femoral head (ANFH) is a severely disabling disease of the hip. Several clinical trials have shown promising outcomes on the use of mesenchymal stem cells for the treatment of ANFH, but long-term clinical assessments are lacking. Previously, we reported the 2-year follow-up results of a prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with ANFH. Here, we report the 10-year follow-up results of this study.

Methods: We recruited 43 (53 hips) patients from 2009 to 2010. The hips were randomly allocated to code decompression (CD) with or without bone marrow buffy coat (BBC) grafting. Participants underwent follow-up at 24, 60, and 120 months postoperatively. The visual analogue scale (VAS), Lequesne algofunctional index, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis scores were recorded. Survival rate analysis and prognostic factor analysis were performed. The endpoint was defined as progression to Ficat stage IV or conversion to hip arthroplasty.

Results: A total of 31 patients (41 hips) were included in the final analysis. The CD + BBC group had better subjective assessment scores than the CD group. The average survival times were 102.3 months and 78.1 months in the CD + BBC group and CD group, respectively (log-rank test, P = 0.029). In the univariate Cox proportional hazards regression model, age [hazard ratio (HR) = 1.079, P = 0.047] and preoperative Ficat stage (HR = 3.283, P = 0.028) indicated a high risk for progression, while the use of BBC (HR = 0.332, P = 0.042) indicated a low risk. Preoperative Ficat stage III was isolated as an independent risk factor for clinical failure in the multivariate model (HR = 3.743, P = 0.018).

Conclusion: The 10-year follow-up results of this prospective, double-blinded, randomized, controlled study showed that the use of autologous BBC in combination with core decompression was more effective than the use of core decompression alone.

Trial registration: ClinicalTrials.gov, NCT01613612 . Registered on 13 December 2011-retrospectively registered.

Keywords: Autologous bone graft; Avascular necrosis of the femoral head; Bone marrow buffy coat; Core decompression.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of the present study. CD core decompression, BG bone grafting, BBC bone marrow buffy coat
Fig. 2
Fig. 2
Functional outcome before and after surgery. Error bars denote the minimum and maximum value of each group. Segments with significant statistical differences (*P < 0.05) between the groups were marked with asterisks. CD core decompression, BG bone grafting, BBC bone marrow buffy coat, VAS visual analogue scale, WOMAC Western Ontario and McMaster Universities Arthritis Index osteoarthritis scoring
Fig. 3
Fig. 3
Anteroposterior plain sequence from the representative cases. a, b and c show the 2-year, 5-year, and 10-year postoperative anteroposterior plain of a 24-year-old male with the diagnosis of ANFH (Ficat stage IIB) caused by steroid. He was assigned in the CD + BG + BBC group. At 10-year follow-up, the necrotic region progressed slightly. d, e, and f show the 2-year, 5-year, and 10-year postoperative anteroposterior plain of a 26-year-old female, who underwent the treatment of CD + BG because of idiopathic ANFH (Ficat stage IIA). At 10-year follow-up, it showed progressive decrease in the necrotic region and the hip showed significant degeneration
Fig. 4
Fig. 4
Kaplan-Meier survival curve showing femoral head survival dependent on the treatment. CD core decompression, BG bone grafting, BBC bone marrow buffy coat
Fig. 5
Fig. 5
Univariate (a) and multivariate (b) Cox proportional hazards regression analysis. The forest plot of hazard ratio showed the proportional risk. BBC bone marrow buffy coat, HR hazard ratio, CI confidence interval

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