Minimally invasive treatment for osteonecrosis of the femoral head in ARCO stage <b>Ⅱ</b> and <b>Ⅲ</b> with bioceramic system_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

LU Yajie ¹ ,  WANG Zhen ¹ , LU Xiao ² ,  LU Jianxi ² , CHEN Xiantao ³ , NIU Dongsheng ⁴ , FENG Xianfa ⁵ , ZHANG Chengquan ⁶ , YU Jinwei ⁷ , WANG Baocang ⁸

1. Department of Orthopedics, the First Affiliated Hospital of the Air Force Medical University of Chinese PLA, Xi’an Shaanxi, 710032, P.R.China;
2. Shanghai Bio-lu Biomaterials Co., Ltd., Shanghai, 200000, P.R.China;
3. Department of Orthopedics, Luoyang Orthopedic-Trumatological Hospital of Henan Province (Henan Provincial Orthopedic Hospital), Luoyang Henan, 471000, P.R.China;
4. Department of Orthopedics, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan Ningxia, 750021, P.R.China;
5. Department of Orthopedics, Songyuan Central Hospital, Songyuan Jilin, 138000, P.R.China;
6. Department of Orthopedics, Hanzhong Central Hospital, Hanzhong Shaanxi, 723000, P.R.China;
7. Department of Orthopedics, the Second People’s Hospital of Jiaozuo, Jiaozuo Henan, 454150, P.R.China;
8. Department of Orthopedics, the Second Hospital of Tangshan, Tangshan Hebei, 063000, P.R.China;

Corresponding author：

WANG Zhen, Email: wangzhen@fmmu.edu.cn; LU Jianxi, Email: lujianxi888@hotmail.com

Keywords：

Osteonecrosis of the femoral head; bioceramics; vascularization; biomechanics; multicenter clinical study

DOI：

10.7507/1002-1892.201904066

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Objective To perfect the theory system of minimally invasive treatment for osteonecrosis of the femoral head (ONFH) with β tricalcium phosphate (β-TCP) bioceramic system and evaluate the effectiveness. Methods Eighteen New Zealand white rabbits aged 7-8 months were used to establish an animal model to verify the vascularization of porous β-TCP bioceramic rods. Micro-CT based three-dimensional reconstruction and fluorescence imaging were used to display the new blood vessels at 4, 8, and 12 weeks after operation. The inserting depth, number and diameter of vessels in the encapsulated area were analyzed. Nine pig femoral specimens were randomly divided into 3 groups (n=3): group A was normal femur; group B had cavity (core decompression channel+spherical bone defect in femoral head); in group C, mixed bioceramic granules were implanted to fill the defect in femoral head, and porous β-TCP bioceramic rod was implanted into decompression channel. The stiffness and yield load of specimens were analyzed by biomechanical test. A multicenter retrospective study was conducted to analyze 200 patients (232 hips) with femoral head necrosis treated with bioceramic system in 7 hospitals in China between January 2012 and July 2018. There were 145 males and 55 females, with an average age of 42 years (range, 17-76 years). According to the Association Research Circulation Osseous (ARCO) stage, 150 hips were in stage Ⅱ and 82 hips in stage Ⅲ. Postoperative imaging assessment was carried out regularly, and hip function was evaluated by Harris score. The effectiveness of ARCO stage Ⅱ and Ⅲ was also compared. Results Animal experiments showed that blood vessels could grow into the encapsulated area and penetrate it at 12 weeks. The inserting depth, number and diameter of blood vessels in the encapsulated area gradually increased, and there was significant difference between different time points (P<0.05). Biomechanical tests showed that the stiffness and yield load of specimens in groups B and C were significantly lower than those in group A, while the yield load in group B were significantly lower than that in group C (P<0.05). The stiffness in group C was restored to 41.52%±3.96% in group A, and the yield load was restored to 46.14%±7.85%. Clinical study showed that 200 patients were followed up 6-73 months, with an average of 22.7 months. At last follow-up, 12 patients (16 hips) underwent total hip arthroplasty, and the hip survival rate was 93.10%. According to the imaging evaluation, 184 hips (79.31%) were stable and 48 (20.69%) were worse. Harris score (79.3±17.3) was significantly higher than that before operation (57.3±12.0) (t=18.600, P=0.000). The excellent rate of hip function was 64.22% (149/232). The survival rate of hip joint, imaging score and Harris score of patients in ARCO stage Ⅱ were better than those in ARCO stage Ⅲ (P<0.05). Conclusion β-TCP bioceramic system can guide the abundant blood supply of greater trochanter and femoral neck to the femoral head to promote repair; it can partly restore the mechanical properties of the femoral head and neck in the early stage, providing a new minimally invasive hip-preserving method for patients with ONFH, especially for those in early stage.

Citation： LU Yajie, WANG Zhen, LU Xiao, LU Jianxi, CHEN Xiantao, NIU Dongsheng, FENG Xianfa, ZHANG Chengquan, YU Jinwei, WANG Baocang. Minimally invasive treatment for osteonecrosis of the femoral head in ARCO stage Ⅱ and Ⅲ with bioceramic system. Chinese Journal of Reparative and Reconstructive Surgery, 2019, 33(10): 1291-1298. doi: 10.7507/1002-1892.201904066 Copy

1.	Cooper C, Steinbuch M, Stevenson R, et al. The epidemiology of osteonecrosis: findings from the GPRD and THIN databases in the UK. Osteoporos Int, 2010, 21(4): 569-577.
2.	Liu TG, Chen WH. Research progress of epidemiology about non-traumatic osteonecrosis of femoral head. Medical Recapitulate, 2009, 15(17): 2637-2639.
3.	Liu F, Wang W, Yang L, et al. An epidemiological study of etiology and clinical characteristics in patients with nontraumatic osteonecrosis of the femoral head. J Res Med Sci, 2017, 22: 15.
4.	Zhao DW, Yu M, Hu K, et al. Prevalence of nontraumatic osteonecrosis of the femoral head and its associated risk factors in the Chinese Population: results from a nationally representative survey. Chin Med J (Engl), 2015, 128(21): 2843-2850.
5.	赵德伟, 谢辉. 成人股骨头坏死保髋手术治疗的策略及探讨. 中国修复重建外科杂志, 2018, 32(7): 792-797.
6.	Zhao D, Qiu X, Wang B, et al. Epiphyseal arterial network and inferior retinacular artery seem critical to femoral head perfusion in adults with femoral neck fractures. Clin Orthop Relat Res, 2017, 475(8): 2011-2023.
7.	Gao P, Zhang H, Liu Y, et al. Beta-tricalcium phosphate granules improve osteogenesis in vitro and establish innovative osteo-regenerators for bone tissue engineering in vivo. Sci Rep, 2016, 6: 23367.
8.	Feng B, Jinkang Z, Zhen W, et al. The effect of pore size on tissue ingrowth and neovascularization in porous bioceramics of controlled architecture in vivo. Biomed Mater, 2011, 6(1): 015007.
9.	Xiao X, Wang W, Liu D, et al. The promotion of angiogenesis induced by three-dimensional porous beta-tricalcium phosphate scaffold with different interconnection sizes via activation of PI3K/Akt pathways. Sci Rep, 2015, 5: 9409.
10.	Xu S, Lin K, Wang Z, et al. Reconstruction of calvarial defect of rabbits using porous calcium silicate bioactive ceramics. Biomaterials, 2008, 29(17): 2588-2596.
11.	Mont MA, Cherian JJ, Sierra RJ, et al. Nontraumatic osteonecrosis of the femoral head: where do we stand today? A ten-year update J Bone Joint Surg (Am), 2015, 97(19): 1604-1627.
12.	Plakseychuk AY, Kim SY, Park BC, et al. Vascularized compared with nonvascularized fibular grafting for the treatment of osteonecrosis of the femoral head. J Bone Joint Surg (Am), 2003, 85(4): 589-596.
13.	Mont MA, Etienne G, Ragland PS. Outcome of nonvascularized bone grafting for osteonecrosis of the femoral head. Clin Orthop Relat Res, 2003, (417): 84-92.
14.	Liu ZH, Guo WS, Li ZR, et al. Porous tantalum rods for treating osteonecrosis of the femoral head. Genet Mol Res, 2014, 13(4): 8342-8352.
15.	Wang Q, Zhang H, Li Q, et al. Biocompatibility and osteogenic properties of porous tantalum. Exp Ther Med, 2015, 9(3): 780-786.
16.	Pandolfi L, Minardi S, Taraballi F, et al. Composite microsphere-functionalized scaffold for the controlled release of small molecules in tissue engineering. J Tissue Eng, 2016, 7: 2041731415624668.
17.	Zhang C, Zeng B, Xu Z, et al. Treatment of femoral head necrosis with free vascularized fibula grafting: a preliminary report. Microsurg, 2005, 25(4): 305-309.
18.	吴敏, 官建中, 肖玉周, 等. 带旋髂深血管蒂骨膜瓣植入治疗未成年股骨颈骨折术后股骨头缺血性坏死. 中国修复重建外科杂志, 2015, 29(3): 275-279.
19.	Ligh CA, Nelson JA, Fischer JP, et al. The effectiveness of free vascularized fibular flaps in osteonecrosis of the femoral head and neck: a systematic review. J Reconstr Microsurg, 2017, 33(3): 163-172.

1. Cooper C, Steinbuch M, Stevenson R, et al. The epidemiology of osteonecrosis: findings from the GPRD and THIN databases in the UK. Osteoporos Int, 2010, 21(4): 569-577.
2. Liu TG, Chen WH. Research progress of epidemiology about non-traumatic osteonecrosis of femoral head. Medical Recapitulate, 2009, 15(17): 2637-2639.
3. Liu F, Wang W, Yang L, et al. An epidemiological study of etiology and clinical characteristics in patients with nontraumatic osteonecrosis of the femoral head. J Res Med Sci, 2017, 22: 15.
4. Zhao DW, Yu M, Hu K, et al. Prevalence of nontraumatic osteonecrosis of the femoral head and its associated risk factors in the Chinese Population: results from a nationally representative survey. Chin Med J (Engl), 2015, 128(21): 2843-2850.
5. 赵德伟, 谢辉. 成人股骨头坏死保髋手术治疗的策略及探讨. 中国修复重建外科杂志, 2018, 32(7): 792-797.
6. Zhao D, Qiu X, Wang B, et al. Epiphyseal arterial network and inferior retinacular artery seem critical to femoral head perfusion in adults with femoral neck fractures. Clin Orthop Relat Res, 2017, 475(8): 2011-2023.
7. Gao P, Zhang H, Liu Y, et al. Beta-tricalcium phosphate granules improve osteogenesis in vitro and establish innovative osteo-regenerators for bone tissue engineering in vivo. Sci Rep, 2016, 6: 23367.
8. Feng B, Jinkang Z, Zhen W, et al. The effect of pore size on tissue ingrowth and neovascularization in porous bioceramics of controlled architecture in vivo. Biomed Mater, 2011, 6(1): 015007.
9. Xiao X, Wang W, Liu D, et al. The promotion of angiogenesis induced by three-dimensional porous beta-tricalcium phosphate scaffold with different interconnection sizes via activation of PI3K/Akt pathways. Sci Rep, 2015, 5: 9409.
10. Xu S, Lin K, Wang Z, et al. Reconstruction of calvarial defect of rabbits using porous calcium silicate bioactive ceramics. Biomaterials, 2008, 29(17): 2588-2596.
11. Mont MA, Cherian JJ, Sierra RJ, et al. Nontraumatic osteonecrosis of the femoral head: where do we stand today? A ten-year update J Bone Joint Surg (Am), 2015, 97(19): 1604-1627.
12. Plakseychuk AY, Kim SY, Park BC, et al. Vascularized compared with nonvascularized fibular grafting for the treatment of osteonecrosis of the femoral head. J Bone Joint Surg (Am), 2003, 85(4): 589-596.
13. Mont MA, Etienne G, Ragland PS. Outcome of nonvascularized bone grafting for osteonecrosis of the femoral head. Clin Orthop Relat Res, 2003, (417): 84-92.
14. Liu ZH, Guo WS, Li ZR, et al. Porous tantalum rods for treating osteonecrosis of the femoral head. Genet Mol Res, 2014, 13(4): 8342-8352.
15. Wang Q, Zhang H, Li Q, et al. Biocompatibility and osteogenic properties of porous tantalum. Exp Ther Med, 2015, 9(3): 780-786.
16. Pandolfi L, Minardi S, Taraballi F, et al. Composite microsphere-functionalized scaffold for the controlled release of small molecules in tissue engineering. J Tissue Eng, 2016, 7: 2041731415624668.
17. Zhang C, Zeng B, Xu Z, et al. Treatment of femoral head necrosis with free vascularized fibula grafting: a preliminary report. Microsurg, 2005, 25(4): 305-309.
18. 吴敏, 官建中, 肖玉周, 等. 带旋髂深血管蒂骨膜瓣植入治疗未成年股骨颈骨折术后股骨头缺血性坏死. 中国修复重建外科杂志, 2015, 29(3): 275-279.
19. Ligh CA, Nelson JA, Fischer JP, et al. The effectiveness of free vascularized fibular flaps in osteonecrosis of the femoral head and neck: a systematic review. J Reconstr Microsurg, 2017, 33(3): 163-172.

Chinese Journal of Reparative and Reconstructive Surgery

Minimally invasive treatment for osteonecrosis of the femoral head in ARCO stage Ⅱ and Ⅲ with bioceramic system

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