课题背景：本课题2002年获得国家自然科学基金资助（30170945），内容是“支撑架结合血管内皮生长因子基因治疗股骨头坏死研究”。本文是其子课题，主要通过将同种异体骨支撑架、自体骨和脱钙骨基质植入髓芯减压后的坏死股骨头内，以加强其力学结构和生物学效应，探讨治疗股骨头坏死的新方法。

应用要点：本实验将经过特殊处理的同种异体骨支撑架植入坏死的股骨头内，发现能对其软骨下骨起到有力的支撑作用，能有效加强股骨头的力学结构，促进坏死骨的修复，防止股骨头关节面的塌陷。

同行评价：股骨头坏死保存股骨头治疗过程中的方法很多，有髓芯减压、干细胞移植、带血管蒂和不带血管蒂的腓骨移植，各种截骨术、骨水泥植入等，均有一定疗效，但没有一种技术是完全满意的。本文从动物和临床实验两方面对同种异体骨支撑架植入行髓芯减压后的股骨头进行研究，并通过各种科研方法探索并验证其有效性。为临床提供了一种新的有应用前景的治疗方式。

摘要
背景：目前常用的加强股骨头力学结构的植骨方法防止塌陷的作用有限，结果并不能完全令人满意。
目的：探讨髓芯减压术后利用同种异体骨支撑架结合自体骨和脱钙骨基质植入强化股骨头力学结构，治疗股骨头坏死的可行性。
设计、时间及地点：随机对照动物实验于2005-10/2006-07在华中科技大学同济医学院协和医院骨科实验室完成。临床病例分析于2001-01/2005-04在协和医院骨科完成。
材料：羊、人同种异体骨支撑架由中国辐射防护研究院山西医用组织库加工制作完成。20只成年雄性大尾羊行双侧股骨头坏死造模。
参试者：早中期股骨头坏死患者23例24髋，排除Ficat IV期及III期关节面受累范围>15%的患者。
方法：①动物实验：18只模型羊随机分为3组，单纯髓芯减压组行坏死股骨头髓芯减压，自体松质骨和脱钙骨基质植入组在行髓芯减压后植入自体松质骨和脱钙骨基质，同种异体骨支撑架植入组在行髓芯减压后植入同种异体骨支撑架、自体松质骨和脱钙骨基质。②临床观察：23例患者均采用同种异体骨支撑架结合自体骨和脱钙骨基质治疗。
主要观察指标：①动物实验：术后5，10和20周对股骨头行影像学、组织学观察和生物力学测定。②临床观察：随访手术前后Harris评分变化、X射线影像学进展。
结果：①动物实验结果：影像学和组织学检查显示同种异体骨支撑架植入组在髓芯减压区骨缺损修复及成骨方面较自体松质骨和脱钙骨基质植入组略高，此两组都较同时期的单纯髓芯减压组明显增强（P < 0.05）；生物力学测试显示同种异体骨支撑架植入组力学强度高于其他2组（P < 0.05）。②临床随访结果：所有患者随访>18个月，Harris评分术前优良率为43.5%，术后优良率为91.3%。22侧髋关节影像学表现保持稳定，无明显并发症发生。
结论：应用同种异体骨支撑架结合自体骨和脱钙骨基质治疗股骨头坏死，能有效加强股骨头的力学结构，促进坏死骨的修复，防止股骨头关节面的塌陷。
关键词：股骨头坏死；生物力学；支架；骨移植；生物材料

梅荣成，杨述华，杨操，李宝兴，李进，叶哲伟.同种异体骨支撑架结合自体骨和脱钙骨基质植入强化力学结构修复股骨头坏死[J].中国组织工程研究与临床康复，2008，12(19):3620-3624
[www.zglckf.com/zglckf/ejournal/upfiles/08-19/19k-3620(ps).pdf]

Biostructural augmentation for the osteonecrotic femoral head by implanting a composite of allogeneic bone support frame, autologous bone and decalcified bone matrix

Abstract
BACKGROUND: Currently, the effect of bone grafting with biostructural augmentation on femoral collapse is not satisfactory.
OBJECTIVE: To evaluate the feasibility to treat osteonecrosis of the femoral head by biostructural augmentation through insertion of allogeneic bone support frame in combination with autologous bone and decalcified bone matrix following core decompression procedure.
DESIGN, TIME AND SETTING: The randomized controlled animal trial was performed at Orthopaedics Laboratory, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology from October 2005 to July 2006; the clinical case analyses were performed at Department of Orthopaedics, Union Hospital from January 2001 to April 2005.
MATERIALS: Goat and human allogeneic bone support frame was developed by China Institute for Radiation Protection Tissue Bank; 20 adult male fat-tailed sheep were selected for models of osteonecrosis of the bilateral femoral heads.
PARTICIPANTS: Twenty-three patients (24 hips) with early or middle stage osteonecrosis of the femoral head were enrolled, and those at Ficat IV stage and III stage and affected articular surface scope＞15% were excluded.
METHODS: Eighteen sheep were randomly divided into 3 groups. Core decompression alone group only underwent core decompression procedure for the osteonecrotic femoral heads; autologous bone and decalcified bone matrix group underwent implantation of autologous bone and decalcified bone matrix following core decompression procedure; allogeneic bone support frame group underwent implantation of allogeneic bone support frame, autologous bone and decalcified bone matrix following core decompression procedure. In addition, 23 patients were treated by implantation of allogeneic bone support frame, autologous bone and decalcified bone matrix.
MAIN OUTCOME MEASURES: Imageology, histological examinations and biomechanic testing were performed in the animals at 5, 10, and 20 weeks after implantation. In addition, the changes of Harris hip scores and the progression in radiographic stages of patients before and after surgery were observed.
RESULTS: Histological and imageological examinations revealed that the bone defect repair and bone formation in allogeneic bone support frame group were better than autologous bone and decalcified bone matrix group, and the two groups were significantly better than core decompression alone group (P < 0.05). The biomechanics test showed the biomechanical properties of the femoral head in allogeneic bone support frame group were significantly superior over the other two groups (P < 0.05). All patients were followed up for more than 18 months. The preoperative excellent rate of Harris scores was 43.5%, and that of postoperative score was 91.3%. The recent follow-up showed that 22 hips were radiologically stable. No major complications occurred.
CONCLUSION: Implanting a composite of allogeneic bone support frame, autologous bone and decalcified bone matrix can enhance biomechanical properties of the femoral heads, promote osteonecrotic bone repair and prevent collapse.

Mei RC, Yang SH, Yang C, Li BX, Li J, Ye ZW.Biostructural augmentation for the osteonecrotic femoral head by implanting a composite of allogeneic bone support frame, autologous bone and decalcified bone matrix.Zhongguo Zuzhi Gongcheng Yanjiu yu Linchuang Kangfu 2008;12(19):3620-3624 [www.zglckf.com/zglckf/ejournal/upfiles/08-19/19k-3620(ps).pdf]