早期的股骨头坏死通常采用髓芯减压术,该方法是通过微创的方法将克氏针钻到骨坏死的区域,降低骨髓内压力,改善骨坏死区域的血液微循环,进而终止或逆转骨坏死的发生和进展。结合患者术前的CT影像制作出3D打印导板,通过导板准确的将克氏针送到骨坏死的中心区域,避免了反复调整克氏针过程中对股骨头血运的破坏,大大降低了手术难度,手术时间缩短到5-10分钟,同时减少了术中X线透视对患者和医生的电离辐射。 图1 此为3D打印导板,通过该导板可以准确的将克氏针穿刺到术前设计的位置。图2 左图为患者术前在CT图像上模拟的克氏针穿刺位置,右图为患者术中减压针穿刺的位置。两图对比可以看出,通过3D打印导板可以使手术更精确。 总而言之,3D打印技术应用于髋周疾病的治疗,手术操作难度、手术时间、手术费用、术后康复、远期疗效等方面都取得了跨越式进展,自技术开展以来,好评如潮,团队将不断完善精准技术,为髋周疾病患者康复带来不竭的希望。
3D打印技术在髋关节发育不良中的应用髋关节发育不良是髋关节外科的常见病,对于60岁以上的患者,通常采取人工关节置换术。年轻患者为避免二次或多次翻修手术的问题,通常采取保留髋关节的手术治疗。目前治疗髋关节发育不良的常用保髋手术方法是截骨术,它是通过截骨后旋转髋臼,增加髋臼对股骨头的覆盖,增加接触面积(图1)。该手术需要做大范围的截骨,手术创伤大、风险高,术后需长时间卧床,恢复时间长,易出现卧床并发症。利用计算机模拟与3D打印技术制作的多孔钽金属髋臼补块可以精准的填补髋臼缺损部分(图2),有效增加髋臼对股骨头的包容,改善两者之间的接触面积,从而延缓或终止髋关节骨性关节炎的进展。该方法利用计算机精准设计,使填补的髋臼盖与股骨头的匹配度达到最佳,同时,多孔结构设计及钽金属有利于骨长入到填补的模块中,使其远期也能够具有较好的稳定性,手术操作简单,无需截骨,对患者损伤小,术后可以早期下床活动,避免卧床并发症。(图3)图1 截骨术的手术示意图。图2 3D打印多孔钽金属髋臼补块治疗髋关节发育不良的手术示意图。箭头所示为3D打印髋臼补块。图3 典型病例:上图为术前CT,可见髋臼对股骨头覆盖不足,同时伴有囊性变;下图为术后CT,可见髋臼对股骨头覆盖明显改善,囊性变被修复。
对于大范围的骨缺损修复术,用3D技术打印出来的金属填充物能够做到与患者骨缺损区域完全贴合,术中无需修整患者自身骨骼以匹配金属植入物,减少对患者的损伤,减少术中出血,缩短手术时长,同时,金属填充物植入后非常稳定,可以与患者自身骨骼完全长合到一起,成为一个整体,因此,术后1-2天即可下地活动,恢复快,远期疗效也非常好。3D打印技术避免了传统治疗方法中利用大块异体骨移植时存在的排斥、感染、植入骨被吸收等风险,也避免了应用固定规格金属填充物时与宿主骨不匹配,需修整原本已经大范围缺损的宿主骨。同时,3D打印技术相比传统治疗方法的医疗费用大大降低,减轻患者的经济负担。对术者而言,术者可以通过3D打印出来的骨骼进行模拟手术,做到心中有数,大大降低了手术难度。 大连大学附属中山医院骨外科赵德伟图1 在计算机中构建骨骼模型(左上图),并制作骨缺损区的金属填充物(右上图),同时进行模拟手术(左下图、右下图)。图2 典型病例:左图为术前X线,可见髋臼杯明显上移,伴有大范围骨缺损,下肢上移短缩,股骨伴有囊性变;右图为术后X线,可见髋臼杯位置良好,髋臼缺损区被金属填充物填充,双下肢等长,股骨囊变区被植骨填充。
中华医学会骨科分会显微修复学组中国修复重建外科专业委员会骨缺损及骨坏死学组中华骨科杂志通信作者:赵德伟股骨头坏死(osteonecroois 0f the femoral head,ONFH),又称股骨头缺m性坏死(avascular necrosis of the femoralhead,AVNFH),是骨科常见病。2006年中华医学会骨科学分会关节外科学组和《中华骨科杂志》编辑部组织国内骨坏死专家拟订了《股骨头坏死诊断与治疗的专家建议》,一定程度上规范了ONFH诊断、治疗及评定方法。2012年3月中华医学会骨科分会显微修复学组及中国修复霞建外科专业委员会骨缺损及骨坏死学组组织相关专业专家对《股骨头坏死诊断与治疗的专家建议》进行了讨论、修改和补充,制订了《成人股骨头坏死诊疗标准专家共识)(2012年版)。一、概述国际骨循环学会(Assaciation Research Circulation Osseous,ARCO)及美国医师学会(American Academy of Orthopaedie Surgeons,AAOS)将ONFH定义为股骨头血供中断或受损,引起骨细胞及骨髓成分死亡及随后的修复,继而导致股骨头结构改变,股骨头塌陷,引起患者关节疼痛、关节功能障碍的疾病,是骨科领域常见的难治性疾病。ONFH可分为刨伤性和非创伤性两大类,前者主要是由股骨颈骨折和髋关节脱位等髋部外伤引起,后者在我国的主要病因为皮质类固醇的应用、酗酒、减压病、镰状细胞贫血和特发性等。二、诊断标准参照日本厚生省骨坏死研究会(Japanese InvestigationCommittee,JIC)及Etienne和Mon提出的诊断标准,制定我国的ONFH诊断标准。(一)临床症状、体征和病史:以腹股沟、臀部和大腿部位为主的关节痛.偶尔伴有膝关节疼痛,髋关节屈曲、内旋、外旋活动受限,常有髋部外伤史、皮质类固醇应用史、酗酒史以及潜水等职业史。(二)x线片改变:疾病早期,股骨头出现密度增高(硬化)和透光区(囊变);病情进一步发展,出现典型的新月征;晚期可出现股骨头塌陷,关节问隙变窄和严重的骨关节改变,髅臼硬化和囊变常见。(三)CT扫描改变:股骨头内可见硬化带包绕坏死骨、修复骨或软骨下骨断裂。(四)MRI征象:坏死区T;WI显示带状低信号或T2wI显示双线征。(五)核素骨扫描:坏死早期呈灌注缺损(冷区);病情进一步发展,出现热区中有冷区现象,即“面包圈样”改变。(六)骨活检:骨小梁的骨细胞空陷窝多子50%,且累及邻近多根骨小梁,骨髓坏死。专家建议:符合上述两条或两条以上标准即可确诊。除(一)、(五)外,符合(--)、(三)、(四)、(六)中的一条即可诊断。三、鉴别诊断对具有类似临床症状、影像学征象的疾患,应作出鉴别诊断(表1)。(一)中、晚期髋关节骨关节炎:常见于中老年人,由于透明软骨的退行性变、软骨软化、糜烂等引起,多累及双侧髋关节,常引起髋关节刺痛。当关节间隙变窄,出现软骨下囊性变时可能与ONFH混淆。其CT表现为硬化并有囊性变,MRI改变以低信号为主,可据此鉴别。(--)髋臼发育不良继发骨关节炎:该病好发于儿童及青年,女性常见,多累及双侧。X线片表现为股骨头包裹不全,关节闻隙变窄、消失,骨硬化、囊变。髋臼对应区出现类似改变,易鉴别。(三)强直性脊柱炎累及髋关节:常见于青少年男性,多为双侧骶髂关节受累,HLA-B27大多阳性,股骨头保持圆形,但关节间隙变窄、消失甚至融合,易鉴别。部分患者长期应用皮质类固醇可合并ONFH,殷骨头出现塌陷,但往往不严重。(四)类风湿关节炎:多见于中老年女性,累及双侧,x线片表现为股骨头保持圆形,但关节间隙变窄、消失。常见股骨头关节面及髋臼骨侵蚀,易鉴别。(五)股骨头内软骨母细胞瘤:通常于儿童晚期或青少年期发病,好发于男性,男女之比为2~3:1。好发于长骨的骨骺和骨突,单侧发病。MRI征象为T:WI呈片状高信号,CT扫描呈不规则的溶骨破坏”j。(六)骨纤维结构不良累及股骨头:该病好发于儿童及青年.女性较常见,是一种病因不明、缓慢进展的自限性良性骨纤维组织疾病。好发于四肢长骨,常累及单侧肢体的多数骨,典型的x线片表现为股骨近端“牧羊人手杖”畸形。(七)暂时性骨质疏松症:可见于中青年,常一侧发病。无明显诱因的髋关节暂时疼痛。X线片示股骨头颈甚至转子部骨量减少。MRI可见T。WI均匀低信号,T2W1高信号,范围可至股骨颈及转子部,无带状低信号,可与ONFH鉴别4J。病灶可在3-12个月内消散。(八)软骨下不全骨折:多见于60岁以上老年患者,女性多见,常单侧发病,无明显外伤史。表现为突然发作的髋部疼痛,不能行走,关节活动受限。X线片表现为股骨头外上部稍变扁。MRI征象:T1wI和T2wI软骨下低信号线,周围骨髓水肿.T2抑脂像为片状高信号”j。(九)色素沉着绒毛结节性滑膜炎:好发于20--40岁的青壮年,多为单关节发病,男女无明显差别。累及髋关节的特点为:髋部轻中度痛伴有跛行,早、中期关节活动轻度受限。CT及X线片表现为股骨头颈或髋臼皮质骨侵蚀,关节间隙轻、中度变窄。Mm征象为广泛滑膜肥厚.低或中度信号均匀分布。(十)骨梗死:该病流行病学特征不详,常为双侧发病。发生在长骨骨干的不同时期的骨梗死其影像学表现不同,MRI表现分别为:(1)急性期:病变中心T.WI呈与正常骨髓等或略高信号,’I'2WI呈高信号,边缘呈长TI、长T2信号;(2)亚急性期:病变中心T-WI呈与正常骨髓相似或略低信号,LWI呈与正常骨髓相似或略高信号,边缘呈长T1、长T2信号;(3)慢性期:T。WI和‘BWI均呈低信号。四、分期ONFIt一经确诊,则应立即进行分期,指导制定治疗方案。准确判断预后。建议采用ARCO分期”J,参考Steinberg分期和Ficat分期),临床可将ONFH分为:早期,ARCO 0期一I期;中期,ARC0Ⅱ期一lllb期;晚期,ARCOⅢc期~Ⅳ期。五、ONFH的治疗0NFH的治疗方法较多,制订合理的治疗方案应综合考虑分期、坏死体积、关节功能以及患者年龄、职业及对保存关节治疗的依从性等因素。(一)非手术治疗主要应用于ONFH早期患者。1.保护性负重:使用双拐可有效减少疼痛,但不提倡使用轮椅‘2.药物治疗:非甾体抗炎药、低分子肝素、氨基二膦酸盐等有一定疗效,扩血管药物也有一定疗效“3.中医治疗:以中医整体观为指导,遵循“动静结合、筋骨并重、内外兼治、医患合作”的基本原则.强调早期诊断、病证结合、早期规范治疗。对高危人群及早期无疼痛患者采用括血化瘀为主、辅以祛痰化湿1151、补肾健骨,具有促进坏死修复、预防塌陷的作用;对于早期出现疼痛等症状的ONFH,在保护性负重的基础上,应用活血化瘀、利水化湿中药,能缓解疼痛,改善关节功能;对于中、晚期0NFH,能配合外科修复手术,提高手术效果。4.物理治疗:包括体外震波、高频电场、高压氧、磁疗等,对缓解疼痛和促进骨修复有益。5.制动与适当牵引:适用于ONFHI早、中期病例。(二)ONFH的手术治疗由于0NFH进展较快,菲手术治疗效果欠佳,多数患者需要手术治疗。手术方式包括保留患者自身股骨头为主的修复、重建手术和人工髋关节置换手术两大类。保留股骨头手术包括髓芯减压术、骨移植术、截骨术、带或不带血运的骨移植术等㈣,适用于ONFH早、中期患者,坏死体积在15%以上的ONFH患者。如果方法适当,可避免或推迟人工关节置换术。1.股骨头髓芯减压术髓芯减压术历史久。疗效肯定。目前可分为细针钻孔减压术和粗通道髓芯减压术。其区别主要是减压通道的直径不同”,细针钻孔减压术的孔道直径为3 nlnl、3.5ml或4ml;粗通道髓芯减压术的孔道直径为6mm。建议采用细针(直径约3mm 左右),在透视引导下多处钻孔。可配合植人材料。髓芯减压联合干细胞移植(或浓集自体骨髓单个核细胞移植)目前属于卫生部部管的三类医疗技术,国内没有广泛开展。基于目前国内部分医疗机构I临床应用的效果较好”1.专家建议应在建立多中心大样本的长期随访报告制度后谨慎应用。2.不带血运骨移植术应用较多的有经股骨转子减压植骨术、经股骨头颈灯泡状减压植骨术等。植骨方法包括压紧植骨、支撑植骨等。应用的植骨材料包括自体皮质骨与松质骨、异体骨、骨替代材料。3.截骨术将坏死区移出股骨头负重区。应用于临床的截骨术包括内翻或外翻截骨、经股骨转子旋转截骨等。截骨术的选择以不改建股骨髓腔为原则。4.带血运自体骨移植自体骨移植可分为髋周骨瓣移植及腓骨移植。髋关节周围带血管蒂骨瓣的选择有多种:(1)带旋股外侧血管升支髂骨(膜)瓣转移术∞3;(2)旋股外侧血管升支臀中肌支大转子骨瓣转移术哺1;(3)带旋股外侧血管横支大转子骨瓣转移术;(4)带旋髂深血管蒂髂骨(膜)瓣转移术;(5)整个股骨头甚至部分股骨颈都受到累及,可以横支大转子骨瓣联合升支髂骨(膜)瓣再造股骨头(颈);(6)髋关节后方人路旋股内侧血管深支大转子骨瓣、臀上血管深上支髂骨瓣等;(7)带股方肌蒂骨瓣(柱)C2s-3”。髋周带血管蒂骨瓣手术创伤小、疗效确切、手术方法容易掌握,推荐使用。为增加股骨头内的强力支撑.在应用髋周带血管蒂骨瓣时可联合植入钽金属棒,可有效避免术后股骨头塌陷。此方法中短期疗效佳,长期疗效有待确定。吻合血管腓骨移植的手术效果日前也较为肯定”应用带血运自体骨移植疗效佳,推荐使用。各种不同血管蒂骨瓣的选择可根据其优缺点、术者的熟练程度等因素综合考虑。5.人丁关节置换术股骨头塌陷较重(ARCOⅢc期、Ⅳ期),出现关节功能严重丧失或疼痛较重时,应选择人工关节置换术。一般认为,非骨水泥型或混合型假体的中、长期疗效优于骨水泥型假体。0NFH人工关节置换术有别于其他疾病的关节置换术,要注意一些相关问题:(1)患者长期应用皮质类固醇,或有基础病需继续治疗,使感染率升高;(2)长期不负重、骨质疏松等原因导致假体容易穿入髋臼;(3)曾行保留股骨头手术。可带来各种技术困难;(4)激素性ONFH、酒精性ONFH不仅仅是股骨头病变,其周围即全身骨质也已受损,所以其长期效果可能不及骨关节炎或创伤性ONFH。六、治疗方案选择的原则选择治疗方案应根据坏死分期、患者年龄、患者对保留关节治疗的依从性等全面考虑。(一)不同分期ONFH的治疗选择对于非刨伤性ONFH病例,如果一侧确诊,则应高度怀疑对侧,行双侧MR检查,建议每3~6个月随访一次。无症状的ONFH:对坏死体积大(>30%)、坏死位于负重区者应积极治疗,不应等待症状出现。建议联合应用髓芯减压术和非手术治疗。ARCOI期:对无症状、非负重区、坏死体积<15%者,可严密观察,定期随访;有症状或坏死体积>15%者。应积极进行下肢牵引及药物等非手术治疗.也可采用保留关节的手术治疗,推荐髓芯减压术(干细胞移植或浓集自体骨髓单个核细胞移植)。ARCOII期:对股骨头尚未塌陷的病例建议采用髓芯减压术(干细胞移植或浓集自体骨髓单个核细胞移植)、带血运自体骨移植术、不带血运的骨移植术(150<坏死体积<30%)。ARCOIlla、皿b期:建议采用各种带血运自体骨移植术。ARC0111 c、IV期:对症状轻、年龄小的病例,可选择保留关节手术,建议采用带血管自体骨骨移植(如带血管蒂大转子骨瓣联合骼骨移植等);对股骨头严重塌陷者建议采用人工全髋关节置换。保留股骨头的手术可以应用其中一种或两种以上的组合术式。建议联合应用,如髓芯减压术配合骨瓣移植。非手术治疗也应在综合治疗范围内。(二)年龄因素与治疗方案的选择青壮年ONFH病例,由于活动量较大,应选择既能保留股骨头又不会对将来可能进行的人工关节置换术造成不利影响的治疗方案。建议采用髓芯减压术(干细胞移植)、带血运自体骨移植术及不带血运的骨移植术(15%<坏死体积<30%)。中年ONFH病例。如果处于ONFH较早期阶段(无塌陷)应尽量保留股骨头,如髓芯减压术、带或不带血运的骨移植术。如果处于ONFH中、晚期,应结合患者主观愿望及技术条件选择保留股骨头治疗或人工关节置换术。当决定采用人工关节置换术时,术前假体选择应充分考虑二次翻修的叮能。老年(年龄超过55岁)ONFH病例,建议采用人工全髋关节置换术。对高龄ONFH病例,应视患者日常活动状况、髋部骨质情况、寿命长短的预期等因素决定。建议采用双极(三极)人工股骨头置换术或人工全髋关节置换术。七、疗效评价及康复锻炼(一)疗效评价对ONFH的疗效评价分为临床评价和影像学评价。临床评价采用髋关节功能评分(如Harris髋关节评分啪]、WOMAC骨关节炎评分[“、中华医学会骨科学分会百分法Ⅲ1等),应根据相同的坏死分期、相似的坏死面积及相同的治疗方法逐例评价。同时建议进行步态分析。影像学评价可应用X线片,采用同心圆模板观察股骨头外形、关节间隙及髋臼变化。ARCOII期以内的病变评估应有MR检查资料。对于带血运骨移植患者,应进行DSA检查,用来评价血运恢复情况m1。专家建议对ONFH患者建立病例档案,积累更多有价值的资料,有助于评价不同病因、不同坏死时期、不同年龄、不同治疗方法的疗效。有利于达成更规范的治疗ONFH的共识。(二)康复锻炼康复锻炼可舫止ONFH患者废用性肌肉萎缩。是促其早目恢复功能的一种有效手段。功能锻炼应以主动为主、被动为辅。由小到大,由少到多,逐步增加,并根据ONFH的分期、治疗方式、髋关节功能评分及步态分析资料选择适宜的锻炼方法。1.卧位抬腿法:仰卧,抬患腿,屈髋屈膝900,动作反复。每Et 200次,分3"4次进行。应用于ONFH保守治疗及外科治疗术后卧床期。2.坐位分合法:坐在椅子上,双手扶膝,双脚与肩等宽,左腿向左.右腿向右同时充分外展。内收。每日300次,分3^4次进行。应用于ONFH保守治疗及外科治疗术后可部分负重期。3.立位抬腿法:手扶固定物.身体保持竖直,抬患腿,使身体与大腿成直角,屈髋屈膝900,动作反复。每日300次,分3,4次进行。应用于ONFH保守治疗及外科治疗术后可部分负重期。4.扶物下蹲法:手扶固定物,身体直立,双脚与肩等宽,下蹲后再起立,动作反复。每日300次,分3--4次进行。应用于0NFH保守治疗及外科治疗术后可完全负重期。5.内旋外展法:手扶固定物,双腿分别做充分的内旋、外展、划圈运动。每日300次,分3--4进行。应用于ONFH保守治疗及外科治疗术后可完全负重期。6.扶拐步行训练或骑自行车锻炼:应用于ONFH保守治疗及外科治疗术后可完全负重期。
赵德伟发表于美国Bone杂志a b s t r a c tArticle history:Received 14 June 2011Revised 31 October 2011Accepted 1 November 2011Available online 07 November 2011Edited by: Thomas EinhornKeywords:Osteonecrosis of the femoral headMesenchymal stem cellsCore decompressionAutologous implantationEarly stageBackground: Treatment of early-stage osteonecrosis of the femoral head (ONFH) with autologous implantationof iliac crest bone marrow-derived mononuclear cells, which contain tens of thousands of bone marrowmesenchymal stem cells (BMMSCs), recently achieved a promising outcome.Methods: One hundred patients with early-stage ONFH were recruited and randomly assigned to BMMSCtreatment or core decompression (CD) treatment. Each BMMSC-treated hip received femoral head (FH)implantation of 2×106 autologous subtrochanteric bone marrow-derived and ex vivo expanded BMMSCs.The radiographic stage of ONFH according to the Association Research Circulation Osseous classification,Harris hip score (HHS), and the volume of the necrotic lesion or the low signal intensity zone (LowSIZ) inthe FH were assessed before and 6, 12, 24, and 60 months after the initial operation.Results: Sixty months after the operation, only 2 of the 53 BMMSC-treated hips progressed and underwentvascularized bone grafting. In CD group, 7 hips lost follow-up, and 10 of the rest 44 hips progressed andunderwent vascularized bone grafting (5 hips) or total hip replacement (5 hips). Compared with the CDgroup, BMMSC treatment significantly improved the HHS as well as decreased the volume of femoral headLowSIZ of the hips preoperatively classified at stage IC, IIB, and IIC (Pb0.05, respectively; stage IIA,P=0.06, respectively). No complication was observed in both treatment groups.Conclusions: Ex vivo expansion of autologous BMMSCs can reliably provide a greater number of BMMSCs forFH implantation. This intervention is safe and effective in delaying or avoiding FH collapse, which may necessitatetotal hip replacement. 2011 Elsevier Inc. All rights reserved.IntroductionOsteonecrosis of the femoral head (ONFH) is a disease in which necrotic bone lesions usually progress to femoral head collapse and symptomatic hip arthritis; the disease mainly affects individuals in their thirty to sixty years of age [1,2]. ONFH is always associatedwith one or more risk factors, such as trauma to the hips, alcohol abuse, excessive use of corticosteroid, hemoglobinopathy, Gaucher's disease, pregnancy, coagulopathies, Caisson disease, organ transplantation,hyperbaric exposure, inflammatory or autoimmune diseases, and other idiopathic mechanisms. However, the pathophysiology of ONFH remains uncertain [3–6].Core decompression (CD) has been widely used to delay the progress of osteonecrotic lesions destroying the femoral head. However, a number of factors may influence the prognosis of such treatment, including alcohol abuse and corticosteroid use, as well as the size and location of the necrotic lesion [6–10]. Although vascularized or nonvascularized autologous bone grafts and osteotomies have also been employed in treating ONFH [4,6,8,9], these procedures remain complicated, expensive, and not widely reproducible. Recent pioneer studies by Hernigou et al. and Gangji et al. have demonstrated the efficacy of autologous bone marrow cell implantation into the femoral head during early-stage ONFH [11–13]. In such procedures, several tens of thousands of bone marrow stem cells, which were isolated and concentrated from anterior iliac crestaspirated bone marrow, were implanted into the osteonecrotic zone in the femoral head right after CD. A novel protocol has been developed in which subtrochanteric bone marrow was directly aspirated through the CD tunnel and bone marrow-derived mesenchymal stem cells (BMMSCs) were cultured ex vitro for about two weeks to obtain millions of cultured BMMSCs for femoral head implantation. The concentration of BMMSCs in harvested autologous bone marrow is relatively lower than that in the ex vivo cultured MSC suspension. To obtain a larger number of BMMSCs without ex vivo expansion, a higher volume of autologous bone marrow must be aspirated. In the current study, about 10 mL of bone marrow were harvested and about 2 mL ofconcentrated BMMSC suspension were obtained by ex vivo expansion. Transplanted BMMSCs are believed to directly differentiate into osteoblasts or into vascular endothelial cells to promote the repair process in vivo [7,11]. The present study aims to assess the safety and efficacy of the above-mentioned novel proceduresin the treatment of early-stage ONFH.MethodsStudy designThis single-center randomized clinical trial was conducted in a university-affiliated hospital in China between May 2004 and July 2006. The objective of this study was to assess the efficacy of cultured bone marrow derived mesenchymal stem cell implantation into the femoral head as treatment against early stage osteonecrosis of the femoral head. The protocol of the present study was approved by the Institutional Review Board of Dalian University and the Ethics Committee of the City of Dalian under the authorization of the Ministry of Public Health of China. Written informed consent was obtained from each patient before enrollment. Participants and randomization Patients with ONFH were recruited at the Dalian UniversityZhongshan Hospital. The inclusion criteria were age between 18 and 55 years, presence of osteonecrotic stages from IC to IIC according to the Association Research Circulation Osseous (ARCO) classification[14], and risk factors, such as trauma, corticosteroid use, alcohol abuse, Caisson disease, and other idiopathic mechanisms. The exclusion criteria were pregnancy, current and previous infections, skeletal immaturity, immunosuppressive drug therapy, a history of inflammatory arthritis, cardiovascular diseases, prior systemic corticosteroid treatment, and mental health problems. The patients who met the inclusion criteria were randomly divided into two groups following the randomization sequence created by a third party not involvedin this study at the time of patient admission (Fig. 1). Patients in one group were treated with core decompression (CD treatment group) and patients in the other group were treated withfemoral head autologous implantation of cultured BMMSCs (BMMSC treatment group).ProceduresBMMSC treatment With the aid of a Stryker's Navigation System, a decompression tunnel was made using a trephine through the trochanter and femoral neck into the necrotic region in the femoral head, 2–3 mm awayfrom the cartilage (Fig. 2A). The medial part of the bone core withdrawn from the trephine was sent for pathological examination (Fig. 2B) and the lateral part was bored with a 1 mm diameter Kirschner wire along its central axis (Fig. 2C). After 10 mL of subtrochanteric bone marrow was aspirated through the decompression tunnel (Fig. 2D), the necrotic segment was removed by a custom-made trephinewith a collapsible scraping end (Fig. 2E). Next, the bored bone core was plugged into the decompression tunnel (Fig. 2F) before the outlet of the decompression tunnel was sealed with bone wax followedby layer closure. The subtrochanteric bone marrow-derived BMMSCs were subjected to proliferation in vitro for two weeks, after which about 2×106 BMMSCs were harvested and prepared in 2 ml normal saline solution later injected into the osteonecrotic site inthe femoral head with a puncture needle through the bored plug andthe decompression tunnel (Fig. 2G). Detailed surgical procedures and BMMSCs culture protocol are described in the online Supplementary data. CD treatment The procedures for CD treatment including establishment ofthe decompression tunnel and removal of the necrotic segmentfrom the femoral head were identical to the BMMSC treatment as described above; however, some steps including bone marrow aspiration from the iliac crest, bone core plug preparation, and BMMSC implantation were skipped. Please see detailed procedures described in the online Supplemental data. Postoperative care After surgeries, all patients were treated prophylactically with an intravenous infusion of cefazolin for 3–5 days. Patients were prohibited from bearing full bodyweight for six weeks. Postoperative rehabilitation followed postoperative care, where all patients followed a strict rehabilitation and training program. Quadriceps muscle and passive range of motion exercises began the first day after surgery. All patients had bed rest with light skin traction for 3 weeks. Patients were allowed assisted weight bearing with two crutches within 3 weeks following the operation. Patients were then instructed topractice weight bearing with a maximum of 30% body weight 4 weeks post-operation. Full weight bearing was permitted at the beginning of the 6th week post-operation.Outcome assessmentsPatients were assessed before and 6, 12, 24, and 60 months after the treatments. Primary outcomes were assessed by radiographic progression in the osteonecrotic stage, as well as pain, function, activity, and motion of the hip, which were measured and recorded with Harris hip score (HHS) [15]; secondary outcomes were evaluated by assessing the size of the osteonecrotic lesion in the femoral head. The study by Hernigou and Lambotte demonstrated a close correlation between the measurements of the necrotic volume in the femoralhead based on the pathologic specimens and the necrotic volume (low signal intensity zone) in magnetic resonance images (MRIs) [16]; therefore, following the methods described by Steinberg et al. and Gangji et al. [12,17] in determining the osteonecrotic volume in the femoral head, we used an ImageJ image analysis software to measure the actual sizes of the necrotic lesion and the non-affected zone in the femoral head on each of the 20 transverse T1-weighted MRI slices with 3 mm slice thickness acquired with a 1.5 T PHILIPS Intera Achieva MRI Scanner, and then calculated the percent volume of the necrotic lesion (before the surgery) or the low signal intensity zone (LowSIZ [after surgical removal of the necrotic lesion]) of the femorahead. All the preoperative and postoperative assessments were done by the authors who were unaware of the group assignment.Statistical analysisData are presented as “mean” or “mean±SEM”. The significance of differences between the two treatment groups in terms of patient characteristics was examined using the χ2 test or the Fisher's exact test for categorical variables. Within each treatment group, significance of difference in the changes of HHS or percent osteonecrotic volume over the entire follow-up period between the groups divided by osteonecrotic stages was assessed using a one-way analysis of variance (ANOVA) followed by Tukey–Kramer multiple comparisonstest. The significance of difference in the changes of HHS or the percent osteonecrotic volume in the femoral head over the entire follow-up period between two treatment groups with hips at the same ARCO stage or two groups of hips at different stages but within the same treatment was tested with two-way ANOVA. An unpaired t test was used to examine the difference in HHS or percent volume of necrotic lesion/LowSIZ of the femoral head, or in the percent change against the preoperative baseline level between the two treatmentgroups, a P-value of less than 0.05 was considered statistically significant. All statistical analyses were performed using GraphPad Prism software (Version 5.0).ResultsPatients Between May 2004 and July 2006, 100 patients with 104 hips affected by ONFH enrolled in the current study. These patients were randomly assigned to the CD (50 patients/51 hips) and BMMSC (50 patients/53 hips) treatment groups. Follow-up assessments were performed 6, 12, 24, and 60 months post-operation. Seven patients (7 hips) in the CD treatment group did not complete the follow-up examinations because of family relocation, whereas all patients in the BMMSC treatment group completed their follow-ups (Fig. 1). The demographic data of the patients were recorded during the preoperative visit. Patients in the two treatment groups were statistically comparable in age, sex, and osteonecrotic stages (Table 1).Primary outcomesSixty months after the initial surgeries, 10 of the 44 CD-treated hips had progressed to stage III or IV ONFH, whereas only 2 of the 53 BMMSC-treated hips had progressed to stage III, demonstrating that BMMSC treatment significantly protected the treated hips from progressing to higher osteonecrotic stages (Pb0.05, as examined by Fisher's Exact Test). Of the ten CD-treated hips, 5 hips that progressed to ARCO stage III or IV underwent total hip replacement, including 1 case before 36 months post-operation, 2 cases between 36 and48 months, and 2 cases between the 48 and 60 months postoperation; the other five hips that progressed to ARCO stage III had vascularized bone grafting, including 3 cases before 36 months, 1 case between 36 and 48 months, and 1 case between 48 and 60 months post-operation. In contrast, no total hip replacementwas needed in BMMSC-treated hips, wherein the two hips, which progressed from IIA to IIIA or IIC to IIIC, respectively, underwent vascularized bone grafting between 24 and 36 months after the initial surgeries (Fig. 3, survivorship curves). Over the 60-month postoperative period, statistically improved HHS was found in CD- and BMMSCtreated hips except for the CD-treated hips that were preoperatively classified as stage IC (Fig. 4, upper panel), demonstrating the efficacy of both treatments against early stage ONFH. Compared with CDtreatment, BMMSC treatment contributed to greater improvement of HHS in hips of Stages IC (Pb0.01), IIA (P=0.06), IIB (Pb0.01), and IIC (P=0.02) (Fig. 4). As results, the mean HHS of BMMSCtreatedhips of each stage, which was assessed 60 months after the initial surgery, was statistically higher than that of CD-treated hips (Fig. 4, upper panel). Specifically, the percent increase in HHS assessed at the 60-month follow-up against the preoperative baseline (identified as “0 month” in Fig. 4) in BMMSC-treated hips preoperatively classified as stage IIB or IIC was statistically greater than that of the corresponding CD-treated hips (Stage IIB, 129.0% vs. 104.1%, Pb0.05; Stage IIC, 109.9% vs. 79.1%, Pb0.05, tested by unpairedt tests). Secondary outcomes Quantitative volumetric measurements remain the most reliable method to determine the true size of a three-dimensional osteonecrotic lesion in the femoral head [18].In the present study, MRI examination was performed before and 6, 12, 24, and 60 months after the surgery, and the volume of the necrotic lesion or LowSIZ in the femoral head was measured following the methods described by Steinberg et al. and Gangji et al. [12,17] and expressed as the percent necrotic volume of the femoral head (before the surgery) or percent LowSIZ volume of the femoral head (after the surgical removal ofthe necrotic lesion). Sixty months after the initial surgery, statistically decreased LowSIZ volumes in the femoral head were found in both treatment groups, except the CD-treated hips preoperatively classifiedas stage IIA. Over this postoperative period, BMMSC treatment greatly decreased LowSIZ volume in the femoral head of the hips at each preoperative stage, compared with CD treatment (Fig. 4C, stage IC, P=0.014; stage IIA, P=0.06; stage IIB, Pb0.001; and stage IIC, Pb0.001). Among the hips at advanced osteonecrotic stages such as IIB and IIC, statistically greater percent decrease in the LowSIZ volume was found in the BMMSC-treated hips compared with CDtreated hips (Fig. 5, lower panel, Pb0.001, respectively). Accordingly,the remaining volume of LowSIZ in BMMSC-treated hips was significantly smaller than that of the CD-treated hips at stage IIB (6.5% versus 13.3%, Pb0.001) or IIC (13.8% versus 29.3%, Pb0.001). Within the BMMSC treatment group, the percent decrease in the volume of LowSIZ in the femoral head was greater in the hips of stage IIB or IIC than that of the hips at stage IIA (Fig. 5, lower panel, Pb0.001 orP=0.046, respectively). As shown in the left panels of Figs. 6A, C, E, and G, BMMSC treatment constantly decreased the volume of LowSIZ in the femoral head. In contrast, in many CD-treated hips, apparentdecreases in the LowSIZ volume were found only during the first 24 months post-operation, after which the LowSIZ remained no change or increased over time (Fig. 6, right panels).DiscussionThe current study demonstrates that autologous implantation of cultured BMMSCs into the femoral head is a safe and effective treatment against early-stage ONFH. Compared with CD treatment, BMMSC implantation can significantly decrease the pain and other joint symptoms caused by osteonecrosis and delay or avoid the progress of this disease towards higher osteonecrotic stages or collapse of the femoral head, which may necessitate additional surgeries including total hip replacement. Theoretically, the necrotic bone can be repaired by the bone progenitor cells in the femoral head. However, osteonecrotic changes in the femoral head can decrease the number of bone progenitor cells in the uninvolved part in the femoral head [19]. Based on the fact that the stromal component of the red bone marrow is the source of osteogenic precursor cells [20], promising results have been achieved in a number of studies undertaken to assess the efficacy and safetyof autologous implantation of bone marrow mononuclear cells into the necrotic zone in the femoral head [11,12,21]. According to their protocols, surgical procedures were performed to aspirate severalhundred milliliters of bone marrow from the anterior iliac crest. Subsequently, the bone marrow mononuclear cells were isolated and concentrated into a final volume of about 50 mL containing several tens of thousands of stem cells in terms of fibroblast colony-forming units for implantation in to the femoral head [11,12,21]. In the present study, about 10 mL of bone marrow from the subtrochanteric region were directly aspirated once the decompression tunnel was established in the surgery, abandoning the procedures for bone marrow aspiration from the iliac crest. Expansion of autologous BMMSCs ex vivo allowed the harvesting of sufficient amounts of cultured BMMSCs within two weeks and preparation about 2×106 BMMSCs for FH implantation, which was much greater than the number of implanted bone marrow stem cells per FH reported by other researchers [11,12,21]. Recent findings demonstrated an increase in the level of vascular endothelial growth factor in hematoma [22], which could promote angiogenesis and osteogenesis of mesenchymal stem cells [22,23]. Therefore, we speculate that the organization of hematoma in the plugged decompression tunnel and the cavity of the cleaned necrotic site provides not only an ideal reservoir with which to retain the implanted BMMSCs, but also an optical microenvironment to promote the differentiation of the BMMSCs, which contributes to the repair and revascularization of the femoral head. Recent findings by Feng et al. also associated decreased number of circulating endothelial progenitor cells with osteonecrosis of the femoral head [24], suggesting a negative influence in angiogenesis and vascular repair in the affected femoral head; however, such condition could be compensated by the implantation of BMMSCs into the femoral head since bone marrow mesenchymal stem cells were found to differentiate into endothelial cells both in vitro and invivo [25,26]. The size and location of the necrotic lesion are considered to be the most important prognostic factors [6–10]. According to our experience, a navigation system can offer the surgeons not only 3- dimensional mapping of the anatomical features but also virtual real-time imaging, guiding the trephine on the way towards the necrotic lesion without malpositions, and simultaneously reducingintraoperative fluoroscopic time. However, a number of problems exist with the navigation system, including a relatively low level ofimage resolution as well as a relatively high acquisition cost. Therefore, MRI examination remains an effective way in determining the size and location of a necrotic lesion in the femoral head with a relatively high resolution, ensuring a thorough curettage and evacuation of the necrotic lesion. We propose since successful repair of the necrotic damage in the femoral head can result in constant alleviation of pain and amelioration of the function, activity, and motion of the hip, as well as a constant decrease in the volume of the LowSIZ crucially, it should be considered a factor that predicts the clinical outcomes of this disease. Such a proposal could be supported by the most recent findings of Hernigou and colleagues, who had followedup 342 patients with 534 hips at osteonecrotic stage I or II according to the Steinberg classification [17] for 8 to 18 years after autologous bone marrow grafting [13]. During the most recent follow-up, a mean HHS of 88 points (improved from a mean preoperative HHS of 70 points) was exhibited in 440 hips that did not need total hip replacement, of which 69 hips preoperatively classified as stage I exhibited total resolution of osteonecrosis and the other 371 hips only exhibited a mean volume of 12 cm3 (decreased from a mean preoperative volume of 26 cm3) of LowSIZ without a marginal band-like pattern on T1-weighted MRIs [13]. Given the fact that thefemoral head has an average volume of 60 cm3, the 12 cm3 LowSIZ could be estimated to be 20% in volume of the femoral head [11]. Therefore, this large sample study suggests that the reconstructive repair is a slow process, taking at least 8 years to improve the HHS to a mean of 88 points and to decrease the percent volume of LowSIZ to a mean of 20% of the femoral head. In the present study, the mean HHS of the BMMSC-treated hips was increased to 88 points and the percent LowSIZ volume of the femoral head was decreased to amean of 15% at 60 months post-operation, suggesting a rapid reconstructive repair process promoted by BMMSC implantation, which predicts an optimistic outcome. As demonstrated in Fig. 3, for example,LowSIZ remains in the BMMSC-treated hip 60 months after the initial surgery (Fig. 6G); therefore, follow-up examination will be continued and updates especially about the complete healing of the affected hips in the BMMSC treatment group will be reported in the future.ConclusionsIn summary, obtaining a significantly larger number of BMMSCs through ex vivo expansion of autologous BMMSCs from a relatively small volume of subtrochanteric bone marrow aspirated throughthe core decompression tunnel is a safe, reliable, and highly effective procedure. The present study demonstrates the efficacy and safety of autologous implantation of ex vivo expanded BMMSCs into the femoralhead for the treatment of early-stage ONFH. Acknowledgments We thank the patients and their families. We thank Drs. S. Zhong (Chinese Academy of Science) and D. Xu (China Southern Medical University) for their discussion and technical advices. This work was supported by China National Natural Science Foundation grants 30670542 and 30471752 (to D. Zhao).Appendix A. Supplementary dataSupplementary data to this article can be found online at doi:10.1016/j.bone.2011.11.002.
赵德伟发表于中华医学杂志,2006,86(7) 股骨头缺血性坏死(Osteonecrosis of the Femoral Head,ONFH)是骨科领域中至今尚未解决的疑难疾病之一,未经及时、有效治疗大多数患者病情将进行性发展,并最终导致严重的髋关节骨性关节炎,使病人丧失劳动能力甚至生活不能自理。人工全髋关节置换术作为一项成熟和经典的骨科治疗技术已经在髋关节疾病的治疗中取得了巨大的成功,但对于中青年ONFH病人应用人工关节置换并发症发生率较高,远期效果并不理想,不少患者一生中不得不接受一次甚至数次的关节翻修手术,而目前关节翻修手术从手术难度、术中创伤到远期效果都仍存在诸多问题。因此,青壮年ONFH治疗的主要目的应是改善症状和功能,尽量保留股骨头,延缓进行关节置换的时间并最终避免人工关节置换而做出努力。 近年来由于高速交通工具普及(外伤)、药物的不规范应用(激素)、生活饮食习惯的改变(饮酒)等原因,使股骨头缺血性坏死的患病率呈明显上升趋势,发病年龄也趋于年轻化。然而对于本病的治疗,由于医师自身诊治水平的不足,出现很多认识上的误区:一方面不少医疗机构及个体诊所,迎合病人惧怕手术的心理,一味采用中医中药方法进行保守治疗,致使很多病人失去了保留股骨头的最佳手术时机;另一方面,很多医生对于股骨头缺血性坏死的患者一律进行人工关节置换,而并没有充分考虑年龄和病变分期,甚至对于年龄仅17~18岁的ONFH患者也进行人工关节置换,使后期的并发症很难处理。所以提高ONFH的诊治水平,严格掌握治疗的适应症是我们应该强调的重要问题之一。 一、ONFH分期与治疗 ONFH分期方法很多,被广泛接受的体系按出现时间顺序为Ficat\Arlet体系、Florida体系、Pennsylvanis体系、日本骨坏死研究会体系、国际骨循环研究会分类(ARCO)体系和Pittsburgh(匹兹堡)体系。然而不管分期方式如何,其目的均为预测病变的自然发展过程并指导临床治疗。到目前为止,Ficat\Arlet体系仍是临床应用最广泛的一种分类标准。对于Ficat I~II期髓芯减压是争议较小的一种术式,其目的是通过减小股骨头髓腔内的压力来恢复股骨头内正常的血运并减轻由此产生的疼痛。该术式操作简单,手术创伤小,术后并发症少,适用于股骨头尚未塌陷的早期患者。近年来为提高疗效和/或减小手术创伤,一些学者对髓芯减压的操作技术进行改良或在髓芯减压的同时结合应用自体或异体成骨物质移植,进一步提高了治疗效果 [6,7,8]。Ficat IV期出现明显的骨性关节炎改变,进行人工关节置换便成为合理的治疗选择。关节置换包括人工全髋关节置换、双极人工股骨头置换和髋关节表面置换,此期病人髋臼常受累及故双极人工股骨头置换和髋关节表面置换并不适用。对于股骨头已经出现不同程度塌陷的中期病例(过渡期、III期) 治疗方法很多,诸如带或不带血管蒂的骨瓣移植、各种截骨术、关节置换术等,由于各种术式术后优良率报道不尽相同,如何选择合理的治疗方案便成为目前争议的焦点。 1.截骨术.通过改变股骨头的负重区域来发挥治疗作用,可分为转子间和经转子截骨两大类[9]。Hasegawa等经过5年和10年的随访,发现带旋髂深血管蒂的髂骨瓣转移治疗缺血性股骨头坏死较转子间旋转截骨有更好的疗效,其股骨头5年和10保存率分别为85%/71%及67%/61%。骨瓣组没有严重的并发症,而截骨组发现有深部感染、转子间骨折、假关节及进行性塌陷等几个主要的并发症[10]。截骨术虽然能在一定程度上减缓股骨头的塌陷,但此术式技术难度高,需要延长恢复时间以使骨质愈合、经常引起下肢不等长或跛行、并发症发生率高、对股骨近端的扭曲不利于以后的全髋关节置换,故临床应慎重使用。 2.不带血管蒂的骨移植,能够减轻髓内压力,自体或异体骨对塌陷或即将塌陷的股骨头提供新的支撑,同时亦起到骨诱导的作用。Mont等应用一种改良的“活门”技术和富含BMP的同种异体移植物治疗缺血性股骨头坏死,19例(21髋)经过平均48个月(36-55个月)的随访,86%(18髋)获得临床成功。病灶较小的病例均获成功,而在病灶较大的14髋中有3髋失败[11]。该术式相对于带血管的骨移植手术操作简单,但病灶清除后植入的骨材需经较长时间的爬行替代过程方可获得足够的支撑强度,因此该术式适用于缺血性股骨头坏死病灶较小的病例。 3.带血管蒂的骨移植. 带营养血管的骨组织瓣移植由于从纠正ONFH的病理生理改变入手,既重建股骨头的血液循环又提供可替代坏死骨质的活骨,经临床应用已经显示出较大的优越性,并有可能成为保留股骨头的主要手术治疗方法。目前应用的这类方法有两类:一是吻合血管的游离腓骨移植术[12.13];一是带血管蒂的骨(膜)瓣转移术。带血管蒂的骨瓣或骨膜瓣移位术由于无需进行显微吻合,因而更易普及推广。由于髋关节周围可供移位的骨(膜)瓣较多,故属于第二类的手术方法有:①带旋髂深血管蒂的髂骨瓣转移术[14];②带旋股外侧血管升支髂骨瓣转移术[15];③带旋股外侧血管升支臀中肌支大转子骨瓣转移术[16];④带旋股外侧血管降支股骨骨膜瓣转移术[17];⑤带旋股外侧血管横支大转子骨瓣转移术[18];⑥带旋股内侧血管深支或臀下血管吻合支大转子骨瓣转移术[19,20];⑦带旋股外侧血管横支大转子骨瓣联合髂骨(膜) 瓣转移股骨头修复与再造术[21]。以上各种带血管骨瓣转移的治疗方法,手术入路及取材部分各有不同,这要根据病损部位及手术者自身经验而定。我们单独或联合应用带旋股外侧血管升支髂骨瓣、带旋股外侧血管横支大转子骨瓣、带旋股外侧血管降支骨膜支骨膜瓣、带旋髂深血管蒂髂骨瓣及带旋股外侧血管升支臀中肌支大转子骨瓣转移的方法修复与再造股骨头,1005例(1226侧)经平均5.1年的随访,股骨头得到重建的病例,术后Harris髋关节功能评分明显提高(术前平均56.2,术后平均85.8),其中临床成功率为89.4%(1041髋),影像学成功率为75.4%(878髋)。根据Ficat骨坏死分期标准,II期优良率为95.3%,III期为87.9%,IV期为60.8%。对于股骨头坏死范围广泛或出现严重塌陷的晚期病例,股骨头关节面软骨出现明显缺损或破坏,应用常规骨瓣或单一骨瓣转移往往不能完成股骨头的修复,应用带血管蒂的大转子骨瓣或联合髋周其它骨(膜)瓣转移再造股骨头,远期成功率可达60%以上[21]。由于这种治疗方法即使失败也不会对全髋关节置换产生不良影响,故当考虑到青壮年病人进行人工关节置换后必将面临翻修手术的巨大心理压力和经济负担,对晚期病例进行股骨头的修复与再造仍不失为一种有退路的治疗选择。 二、年龄因素与治疗方案 随着人工关节制备工艺和手术操作技术的不断发展和完善,关节置换的年龄适应症已经降为55岁,年龄大于55岁的老年患者成骨能力差,血管条件也不如青壮年,保留股骨头的治疗措施成功率相对较低,因此对于此年龄段的ONFH病例,通常进行人工全髋关节置换。 对于年龄在20岁~40岁的 ONFH病例,由于患者活动量较大,选择即能保留股骨头又不至于对可能进行的人工全髋关节置换造成不利影响的治疗方案应该是临床医生积极努力的方向。 对于40岁~55岁的病例,如果处于ONFH的较早期阶段同样应该尽最大努力保留股骨头,如果处于ONFH的中晚期,则应该结合患者的主观愿望及技术条件即可选择保留股骨头的治疗措施,也可以选择创伤小又有退路的关节置换术,如髋关节表面置换。当决定进行全髋关节置换时,术前假体选择应充分考虑二次翻修的可能。 总之,虽然ONFH的治疗方法很多,但对于中晚期病例的治疗方案尚未统一。如何在缓解症状和改善功能的前提下,尽可能的保留股骨头,避免进行关节置换或延迟关节置换的时间应该是选择治疗方案时重点考虑的问题。作者认为在ONFH病因等诸多问题未被彻底揭示前,如何准确判断本病的病程以及受累的范围,采用操作相对简单而效果确切的方法来阻止本病的进一步发展,应该是髋关节外科医生的首要任务。
赵德伟发表于CLINICAL ORTHOPAEDICS AND RELATED RESEARCH杂志We determined the long-term clinical and radiologic outcomesof patients with osteonecrosis treated with a combinationof autologous cancellous bone impaction and pediclediliac bone block transfer perfused by the ascending branch ofthe lateral femoral circumflex artery. We retrospectively reviewed197 patients (226 hips) operated on from 1985–1998who had a mean age of 38 years (range, 19–65 years) and anaverage followup of 12.5 years (range, 6–19 years). Fourteenhips (13 patients) (6%) had conversion to a total hip arthroplastybecause of progressive collapse, severe pain, or both.Of the remaining 212 reconstructions, 195 hips were clinicallysuccessful (92%), and 76% were radiographically successful.The postoperative Harris hipscore substantially improvedin the patients without hip failure. Successful resultswere achieved in 96% of the patients with Ficat and ArletStage II osteonecrosis, 90% with Stage III osteonecrosis, and57% with Stage IV osteonecrosis. Good results were obtainedin 94% of the patients younger than 45 years. Our datasuggest the method is useful for treating osteonecrosis of thefemoral head only in active symptomatic patients with goodintegrity of hip cartilage and Stages II or III osteonecrosis.Level of Evidence: Therapeutic study, Level IV (case series).See the Guidelines for Authors for a complete description oflevels of evidence.Osteonecrosis, a relatively common disease in younger,active patients seemingly has a wide range of etiologiesand a poorly understood pathogenesis.16,20–22,30,36,38,40,51Despite improvements in hip arthroplasty design and techniques,it is unlikely that prosthetic replacements will endurefor life.5,8,25,41,44 Alternatively, various headpreservingprocedures have been used to avert or delay theneed for a total hip arthroplasty (THA). The proceduresinclude core decompression,4,11,33,37 various types of osteotomies,17,26,42,47 different methods of nonvascularizedbone grafting procedures,6,31,32,37 vascularized bone graftingincluding the fibula,1,23,48 and iliac crest boneblock13,18,29 transfer for revascularization of necrotic boneaimed at directly influencing the pathologic event.10 Todate, no single treatment method has been shown to reliablyprevent progression.Symptomatic osteonecrosis of the femoral head typicallyprogresses with collapse and incongruity of thejoint.13 Therefore, it is worthwhile investigating methodsthat restore sphericity of the femoral head and revascularizethe necrotic bone to minimize the risk of collapse.Although the vascularized fibula has been widely used, avascularized bone graft from the iliac crest with decreaseddonor site morbidity might be anattractive alternative.10,15,18,27 The efficacy of vascularized procedures alsomight be enhanced by nonvascularized bone grafting,which could provide structural support to the subchondralbone and articular cartilage to prevent collapse during therepair mechanism.31,32,37 The iliac crest bone block perfusedby the ascending branch of the lateral femoral circumflexartery was selected in this study because it can beobtained and implanted through the same single incisionwithout dissecting or exposing the inguinal ligament.10,54We have used this technique since 1985. It involvestotal excision of the necrotic bone through a window madeat the femoral head-neck junction. The necrotic bone thenis replaced by impacted autologous cancellous bone associatedwith a vascularized iliac bone block transfer to improvethe mechanical properties of the femoral dome andto revascularize the femoral head.We wanted to determine whether this procedure providesdurable, improved function and whether the improvedfunction differs by stage or size of necrotic areas orage of patients.MATERIALS AND METHODSWe retrospectively reviewed 243 hips in 211 consecutive patientswith segmental femoral head necrosis treated from 1985–1998. All patients had a vascularized iliac bone graft combinedwith an autologous cancellous bone impaction and were operatedon by one surgeon (DWZ). Of these, 197 patients (226 hips)were evaluated clinically and radiographically at an average followupof 12.5 years (range, 6–19 years) postoperatively. Fivepatients died after a mean of 7 years postoperatively from causesunrelated to the index hip surgery, three patients moved abroad,and six patients were lost to followup. In these 14 patients, thelast note in the records indicated an asymptomatic hip. The endof followup was determined by the time of conversion to totalhip arthroplasty (14 hips in 13 patients) or the long-term followup.The average age of the 197 patients (126 men and 71women) was 38 years (range, 19–65 years) at the time of surgery.The diagnosis of osteonecrosis was based on clinical history;anteroposterior (AP) and frog-leg lateral radiographs, andcomputed tomography (CT) (27 patients at the later stage of thestudy).The etiology of the osteonecrosis was steroid use in 53 patients(65 hips), alcohol abuse in 14 patients (23 hips), posttraumaticin 58 patients (59 hips), idiopathic in 51 patients (57 hips),hyperlipidemia in nine patients (one patient had bilateral involvement),postinfectious in 11 patients, pregnancy-related inone patient, and other in 21 patients (22 hips). Each hip is discussedseparately, independently of whether a patient had bilateralsurgeries. Of the 226 (197 patients) clinically symptomatichips, 91 hips had Ficat and Arlet Stage II osteonecrosis, 93 hipshad Stage III osteonecrosis, and 42 hips had Stage IV osteonecrosis.Patients did not have this procedure if they had FicatStage I osteonecrosis or a cartilage defect.The patient was placed in the supine position with the buttockand ilium elevated 30°. An approximately 12-cm double curveincision was made 4 cm proximal to the anterosuperior iliacspine for an anterolateral approach to the hip (Fig 1). The intervalbetween the sartorius muscle and tensor fasciae lata musclewas located and split in the direction of the skin incision. Carewas taken when splitting the rectus femoris muscle and gluteusmedius muscle before exposing the hip capsule because the ascendingbranch of the lateral femoral circumflex vessels beneaththe rectus femoris muscle enters the tensor fasciae lata laterallyand ascends directly to the anterosuperior iliac crest along thetensor fasciae lata muscle. The vessels were isolated and therespective vascular branches were ligated to the vessels and iliaccrest transplant. Based on the location of the ascending branch ofthe lateral femoral circumflex vessels, a vascularized bone blockwas harvested from the anterosuperior iliac crest that was approximately5-cm long and 3-cm wide, keeping the inner plate ofilium in situ with a vascular pedicle of as much as 12 cm. Thepedicled bone block was saved in saline-wrapped gauze for lateruse and an adequate amount of autologous cancellous iliac boneharvested from the area. The capsule was incised in a T shape toexpose the femoral head and neck. The hip was dislocated andthe femoral head cartilage and acetabular cartilage were inspectedthoroughly to ascertain if there were any full-thicknessdefects or areas of detached cartilage. With defects greater than0.5 cm, we used an alternative microsurgical method to reconstructthe femoral head.53 A bone window approximately 2 cm ×3 cm was made at the femoral head-neck junction using anosteotome. A high-speed abrasive drill was used to remove thedead bone and curette a cavity in the femoral hea until bleedingcould be seen. Specially designed impaction instruments of differentsizes were used to impact autologous cancellous bonegraft from the iliac crest to the excavated region of the femoralhead. An attempt was made intraoperatively to elevate the collapsedsegment of the femoral head with impaction instruments.This area then was supported with the autologous bone graft andthe previously harvested vascularized bone graft (Fig 2). Duringinsertion, care was taken not to squeeze the soft tissue cuffcontaining the vessels to the bone block. The transplant wascompleted by exerting some pressure with impaction instrumentsto achieve solid impaction, and the wound was closed by layers.Bleeding from the cancellous surface of the iliac graft at theconclusion of the surgery was used as an indication of vesselpatency. This procedure took less than 120 minutes to complete(mean, 90 minutes; range, 55–120 minutes).Bed rest with traction was used for 45 days postoperatively toprevent additional collapse and decrease the compression betweenacetabulum and femoral head. After the graft incorporatedwith the host area, progressive weightbearing was permitted.Full weightbearing was achieved by 6 months. Followup radiographicand clinical examinations were done at 3 months, 6months, and yearly thereafter.The clinical results were evaluated by one examiner(WMW),independent of the operating surgeon, using the Harris hip scoringsystem.14 A clinical success was defined as a score 80points. A clinical failure was defined as a Harris hip score lessthan 70 points or conversion to THA. A physical examinationwith calculation of the Harris hip score was done before the iliacbone grafting, before conversion to THA, and at the most recentfollowup.The preoperative radiographs were assessed by two of theauthors (DWZ, WMW) to determine the stage based on thesystem of Ficat and Arlet.12 The diagnosis and surgery involvedwas done before availability of MRI, therefore, recent classificationslike ARCO-system or Steinberg Classification could notbe used. The necrotic area of the femoral head was determinedby conventional AP and frog-leg lateral radiographs obtainedpreoperatively and postoperatively. The sizes of the lesion measurementswere assessed using the combined necrotic angle techniqueof Kerboul et al.24 This angle is derived by adding thesums of the angle of the lesions on AP and lateral radiographs.This radiographic parameter has been compared between patientswith or without hip failure to assess whether it could be aprognostic factor for the result of treatment.32,33,45 Preoperativeradiographs also were used to assess the extent of femoral headcollapse. The hips were categorized according to the degree offemoral head collapse as determined on the AP and lateral radiographs:125 hips had 2 mm collapse or mild collapse, 68hips had 2–4 mm collapse or moderate collapse, and 33 hips had 4 mm collapse or severe collapse. The joint space was measuredon the AP radiograph over the center of the femoral headand was compared with that seen on preoperative and earlypostoperative (within 6 weeks postoperatively) radiographs. Radiographicsuccess was defined as the stability of the stagingaccording to the classification system of Ficat and Arlet.12Because of the possible error in radiographic alignment measurementsbefore the study, an assessment of interobserver andintraobserver error in radiographic evaluation was made. Theintraobserver reliability of the two surgeons (DWZ, WMW) wasexcellent, with 98% agreement. The agreement was an exactmatch in 95% of cases. To avoid the problem of intraobserverand interobserver variability in assessing the various radiographicparameters, two of the authors (DWZ, WMW) independentlyevaluated the radiographs. If there was a disagreement, athird person (XC) interpreted the radiographs until a unanimousdecision could be made regarding the best guess at stage, size,joint space, or degree of collapse.The preoperative and postoperative parameters were comparedby the Mann-Whitney U nonparametric test. Fisher’s exacttest was used for comparison of groups.RESULTSOne hundred ninety-five of the 212 surviving hips (92%)had a successful result at a mean followup of 12.5 years(range, 6–19 years). Harris hip scores improved from amean of 51 points (range, 31–83 points) preoperatively, toa mean of 92 points (range, 62–100 points) at final followupfor surviving hips. The preoperative Harris hipscore for the entire group was 46 points (range, 21–83points). The average postoperative score for all hips was84 points (range, 19–100 points) at the most recent followup or just before conversion to THA (Table 1) (Fig 3).Including the 14 hips treated with THA, the overall outcomein our study was successful in 86% of the 226 hips.Fourteen hips in 13 patients (6%) required conversion to aTHA at a mean followup of 3 years (range, 1–6 years).Two of these hips (two patients) had Ficat Stage II diseaseat the time of the surgery, whereas five hips (five patients)had Ficat Stage III disease and seven hips (six patients)had Ficat Stage IV disease. Preoperatively, patients whohad subsequent conversion surgery to THA had a lower(p 0.005) mean Harris hip score compared with thepatients without hip failure (32 points versus 55 points,respectively). The graft had marginal or no bleeding beforeits insertion into the femoral neck in four patients, andin one patient the vascular pedicle was torn. These fivepatients needed subsequent THAs. Comparing all the patientspreoperatively with the patients without subsequenthip failure at followup, there was a reduction (p0.0001)in pain sensation. The parameters of range of motion(ROM) were not improved (Table 2).Hips with Stage II and Stage III disease were associatedwith a better outcome. Eighty-seven of 91 hips (96%) withStage II disease had successful results, 84 of 93 hips (90%)with Stage III disease had successful results, whereas only24 of 42 hips (57%) with Stage IV disease had successfulresults. For the majority of patients who needed conversionsurgery to THA, the etiology was steroid or alcoholuse (seven patients [50%] and five patients [36%] respectively).Patients who experienced subsequent failure wereolder (p 0.005) at the time of surgery (average, 47years; range, 36–65 years) than patients without hip failure(average, 33 years; range, 19–60 years). Of the patientsyounger than 45 years, 94% had successful results,whereas only 62% of the patients older than 45 years hadsuccessful results.Patients with only moderate or mild collapse of thefemoral head had better results. In hips with mild collapse,120 of 125 hips (96%) had successful results; in hips withmoderate collapse, 58 of 68 hips (85%) had successfulresults; however, in hips with severe collapse, only 17 of33 hips (52%) had successful results. Computed tomographywas used for 32 patients during the followup stage,and radiographs and CT scans show the iliac graft wasfully incorporated in all surviving hips (Figs 4, 5).At the postoperative examination of surviving hips, thestage of the necrosis remained unchanged in 161 hips(76%), 28 hips had deterioration of one stage, three hipshad deterioration of two stages, and 20 hips had progressiveosteoarthritis or progression of collapse. No patienthad improvement in the stage of osteonecrosis. At thelatest followup, 78 hips were classified as having Stage IIosteonecrosis, 76 hips were classified as having Stage IIIosteonecrosis, and 58 hips were classified as having StageIV osteonecrosis. Of the hips with Stage II disease, eighthips progressed to Stage III disease and three hips progressedto Stage IV disease. Twenty hips with Stage IIIdisease progressed to Stage IV disease, and 20 hips withStage IV disease had progressive osteoarthritis or progressionof collapse (Table 3). Radiographically, for the 212surviving hips, 53 additional hips had evidence of slightjoint space narrowing (1–2 mm), which may be interpretedas a result of the deterioration of the stage of the necrosispostoperatively. The preoperative angle of necrosis as defined by Kerboul et al24 was similar in the group of patientswithout hip failure (mean, 226°; range, 162°–268°)and patients with hip failure (mean, 258°; range, 178°–286°).There were no intraoperative complications. Postoperativecomplications occurred in 16 patients (8%). Four patientshad deep venous thromboses, three patients had meralgiaparesthetica, which resolved, and nine patients hadsecondary wound healing.DISCUSSIONThe natural history of symptomatic osteonecrosis of thefemoral head may be progressive, and without operativeintervention it results in collapse and deterioration of thejoint. Orthopaedic surgeons have tried to find a surgicallyeffective solution for preserving the femoral head, but todate no solution has been completely satisfying.23 Of thevarious treatment options, nonvascularized cancellousbone grafting is appealing because it replaces the necroticsegment of the femoral head and has low donor site morbidity.32,37 However, despite successful short-term resultsafter bone graft, the long-term results are not convincing.11Using microsurgical techniques has allowed new therapeuticapproaches for revascularizing necrotic bone to influencethe pathologic process.1,10,18 Free vascularized fibulartransplant and vascularized iliac crest transplants havebeen reported to achieve this aim.10,23,29,48 Some surgeonshave considerable experience with free autogenous vascularizedfibular transplantation, whereas others rely onthe use of vascularized autogenous iliac cresttransplants.15,18,27 However, the necessity for microvascularanastomosis is a disadvantage to the free vascularizedfibular transplant compared with the vascularized iliaccrest transplant.50 Vascularized iliac bone graft perfusedby the ascending branch of the lateral femoral circumflexartery as an alternative method for osteonecrosis has beenused widely in China for approximately two decades withresearch28,53 documented that the vascular branches thatrun into the anterosuperior iliac crest along the tensor fasciaelata musclesconsistently are present. The only variationsof the vasculature were the branches of the artery tothe anterosuperior iliac crest, which would not affect perfusionof the graft. Because this vascularized iliac bonegraft can be harvested and implanted through the samesingle approach used to expose the femoral head anterolaterally,the process is less time consuming and less technicallydemanding.54 Combining the vascular bone transferwith autologous cancellous bone impaction providesinsight as to whether the addition of a vascularized boneblock improves the long-term clinical and radiographicoutcomes compared with nonvascularized bone grafting orvascularized bone block transfer alone.Several limitations must be kept in mind. We had nocontrol group or comparative cohort. Therefore, we cannotensure the surgical technique reduces the development ofosteoarthritis compared with the natural history. However,the results were good compared with those in the literature.There is a certain level of interobserver variability ininterpreting radiographs, but we did this with blinded observerswith good reliability. Postoperative digital subtractionarteriography to confirm patency of the pedicle wasnot available, and we did not monitor postoperative bloodflow through the pedicle. We did check intraoperativeblood flow for patency, but have no evidence that bloodflow through the vascularized graft had a major impact onthe revascularization and salvage of the femoral head.However, we suspect good function of the blood supply inthe postoperative period is crucial for a successful outcome,and that it is important to prevent occlusion of thepedicle in the bone graft at the time of insertion.Despite these limitations, the subjective clinical outcomeof patients without conversion surgery to THA isencouraging at a mean 12.5 years postoperatively. However,most patients reported a decrease in high-demandactivities and sports. There is a discrepancy between clinicaland radiographic outcomes in the current patients. Thismay be because the patients reduced their daily activitiesto accommodate their hip disease. The hips were preservedradiographically in 161 hips in our series. In selected patients,autologous cancellous bone impaction and iliacgraft revascularization potentially may avoid or postponesubsequent conversion to THA and its inherent long-termcomplications. This is significant for a disease that particularlyaffects young patients. Patient selection for thistype of surgery must be restrictive, particularly consideringpreoperative parameters such as stage, age, and collapse.Results of this new procedure should be compared withresults of the traditional bone grafting techniques for thisdisease. In the 1960s and 1970s, nonvascularized bonegrafting techniques were used commonly. Core decompressioncombined with nonvascularized bone grafting hashad less than optimal results. Results have ranged from17%–90% at short to midterm followup (range, 2–8 years),with lower success rates at longer followups.2,3,9,35,39,43,46Nonvascularized bone grafting techniques through a windowin the femoral head cartilage or femoral neck havehad better success rates (81%–83%).31,34,37 In these reports,local bone graft or iliac crest bone was used as thegraft donor. In the late 1970s and early 1980s, vascularizedbone grafting was introduced to improve the success rateof nonvascularized bone grafting for treatment of osteonecrosis.Ishizaka et al18 reported on a cohort of patientstreated with vascularized iliac bone block alone. At 6 yearsfollowup they found a decrease in the average score formobility, and osteoarthritic changes were found in 13 ofthe patients. Ishizaka et al18 had better results in patientswith medial type necrosis than in patients with the necrosisin the lateral weightbearing zone, underlining the importanceof the mechanical properties. In the study of Eisenschenket al,10 clinical results according to the Harris hipscore were good or excellent in 86.6% of the patients, andthe radiographic appearance remained stable in 56.1% ofthe patients according to the Association for Research ofCirculation Osseous (ARCO) classification system after anaverage of 5 years. Urbaniak et al48 assessed the long-termfollowup of patients treated by a vascularized fibula alone.After a mean of 7 years, 31 of 103 hips (31%) requiredconversion to THA. However, if only patients with earlynecrosis are considered, the rate for conversion to THA isonly 17%. Malizos et al29 reported that 35 of 40 (87.5%)patients who had a free vascularized fibular transplant hadradiographically improved or unchanged necrosis after 32months. Although comparison among studies is difficult,the results of our study suggest that the clinical successrate in patients treated with this technique is improvedcompared with results of patients who had nonvascularizedbone grafting or revascularization alone (Table 4).If revascularization is considered, the use of an iliaccrest block perfused by the ascending branch of the lateralfemoral circumflex artery is the logical alternative to avascularized fibula1,50 or another iliac bone graft perfusedby the circumflexed ilium profunda artery,10,18 becausedonor site morbidity can be reduced. The ideal conditionwould be Ficat Stages II or III disease with a mild-tomoderatecollapse of the femoral head that does not involvecartilage destruction in a patient younger than 45years. In patients older than 45 years who have an advancedstage of necrosis and severe femoral head collapse,autologous trabecular bone grafting in combination withrevascularization is not justified.The insertion of a corticocancellous iliac crest transplantperfused by the ascending branch of the lateral femoralcircumflex vessels in the femoral head places a highquality autogenous bone transplant in a weak host bed, andthe impaction with autologous trabecular bone in thefemoral head once occupied by the necrotic bone elevatesthe cartilage and restores the sphericity of the femoralhead. The current procedure has several advantages: restorationof sphericity and prevention of femoral head collapsewith autologous bone impaction; removal of the necroticor poorly vascularized bone replaced with healthycancellous bone and autogenous bony material with reliableblood supply; lack of microvascular anastomosis; and temporary delay or prevention of an additional therapy,such as THA.Although there was a trend toward increasing collapseof the femoral head, the amount of flattening or preoperativelinear collapse of the femoral head was not a predictorof survival or functional outcome. We think that elevationof the collapsed segment intraoperatively and support withimpaction cancellous graft and a pedicled iliac block mitigatesthe influence of this variable on outcome. However,we suspect that if a portion of necrotic bone remains andis not revascularized, this small area will collapse and theprocedure may fail, underscoring the importance of thoroughlydébriding the necrotic lesion and carefully protectingthe vascular pedicle. This may explain why the extentof necrosis as defined by Kerboul et al24 did not influencethe results of this treatment.Our results suggest that vascularized iliac bone blocktransfer combined with autologous cancellous bone impactionas described is not appropriate for patients with advancedstages of osteonecrosis of the femoral head. However,when this procedure is used in patients younger than45 years who have Stages II or III osteonecrosis withmild-to-moderate collapse of the femoral head but integrityof the weightbearing surface, the patients had satisfyingresults regardless of the extent of the sequestrum.
股骨头缺血性坏死的修复与再造 ◎带旋股外侧血管升支髂骨(膜)瓣转移术 ◎带旋股外侧血管臀中肌支大转子骨瓣转移术 ◎带旋股外侧血管横支的大转子骨瓣转移术 ◎带旋股外侧血管降支骨膜支的股骨骨膜瓣转移术 ◎股骨头腾起加股骨头修复术 ◎股骨头修补术 ◎股骨头部分重建术 ◎股骨头全头再造术 ◎股骨头颈部再造术 ◎髋关节成形术
■保留股骨头的手术治疗◎微创治疗股骨头缺血性坏死微创带血管蒂骨瓣转移术在股骨头缺血性坏死中的应用赵德伟发表于中华医学杂志,2007,87(29)中晚期股骨头缺血性坏死(Osteonecrosis of the Femoral Head,ONFH)治疗比较困难,若不进行手术干预大多数患者病情将进行性发展,关节置换往往不可避免。青壮年患者的人工关节置换并发症发生率较高,远期效果并不理想,不少患者一生中不得不接受一次甚至数次的关节翻修手术,而目前关节翻修手术从手术难度、术中创伤到远期效果都仍存在诸多问题[1,2]。因此,对于这部分患者,保留股骨头的手术方法是理想的选择,传统的血管化的骨瓣转移修复手术往往创伤较大,针对这一问题,我院自2001年7月至2006年1月选择性的对一部分病例行微创的带血管蒂骨瓣转移术,早中期临床随访疗效满意。对象与方法一、对象选择自2001年7月至2006年1月于我院手术,且资料完整者232例,均为单侧发病,男146例,女86例,年龄22~55岁(平均39.8岁)。病因:激素性89例,创伤性48例,酒精性46例,特发性41例。从出现症状到接受手术治疗的时间,最短5个月,最长30个月(平均10个月)。体重指数(body mass index,BM I)16.3~ 30.2(平均23.5)。术前根据正位、蛙式位X线片评估,按Ficat[3]分期标准分为,Ⅱ期114例,Ⅲ期96例,IV期22例。对58例患者术前术后行数字血管剪影造影评估,确定血管条件、解剖位置,及术后带血管蒂骨瓣及股骨头内血供。术前Harris髋关节功能评分40~71分(平均57分)。术式选择:带旋股外侧血管升支髂骨瓣转移术83侧;旋股外侧血管升支臀中肌支大转子骨瓣转移术66侧;带旋股外侧血管横支的大转子骨瓣转移术54例;联合带旋股外侧血管横支、升支臀中肌支大转子骨瓣转移术29例。二、方法采用连续硬膜外麻醉,仰卧位,患侧髋部垫高45°。髋前外侧入路,以髂前上棘和髌骨外缘连线为轴线,取弧型切口,切口全长7-11cm(平均9.8cm)。1.带旋股外侧血管升支髂骨(膜)瓣转移术:部分切断缝匠肌和股直肌起始部,将阔筋膜张肌向外拉开,筋膜下可见旋股外侧血管升支主干。沿髂嵴方向分离直到阔筋膜张肌起始处。在髂前上棘外侧取髂骨瓣转移到股骨头颈开窗处,填入股骨头内。2.旋股外侧血管升支臀中肌支大转子骨瓣转移术:在股直肌深面筋膜下找到旋股外侧血管升支,解剖分离显露臀中肌支,带1cm肌肉袖切取大转子骨瓣转移到股骨头颈开窗处,嵌入股骨头内。3.带旋股外侧血管横支的大转子骨瓣转移术:在深筋膜下分离出旋股外侧动脉横支。在前外侧大转子处,切取带血管蒂骨瓣转移到股骨头颈开窗处,填入股骨头内,或在股骨头负重区坏死病灶切除后将带血管蒂的大转子骨瓣转移到股骨头残端,以羊肠线缝合固定。4.联合旋股外侧血管升支臀中肌支及横支大转子骨瓣转移术:沿旋股外侧动脉主干,分别向外上及外下分离出升支及横支血管蒂。按升支走行分离至阔筋膜张肌肌门处,结扎升支髂嵴支及阔筋膜张肌支,带0.5cm肌袖继续分离臀中肌支至大转子的上外侧止点。在同一切口内升支血管下方分离横支血管,于股外侧肌起点下1~2cm处切开部分肌肉,游离血管至大转子前外侧,切取带横支大转子支及臀中肌支的大转子骨瓣转移到股骨头下开窗处。术后皮牵引制动,三周后CPM功能锻炼,3个月后患肢渐进性负重。术后定期随访行影像学评估,以确定是否有分期进展。统计学处理,应用Kaplan-Meier法进行生存分析,以任何原因所导致的关节置换为截尾数据。绘制生存曲线,并做组间分析。结果本组病人随访10~62个月,平均39个月,根据Harris髋关节评分标准进行临床评价,术后Harris评分不小于80分定义为临床成功;影像学评价术后分期稳定定义为影像学成功。全部病例除5例术后出现切口脂肪液化经保守治疗痊愈外,无围手术期并发症。失血量200~450ml(平均340ml),手术时间45min~90min(平均55min)。股骨头得到重建的病例于随访期末进行Harris髋关节功能评分较术前有不同程度的改善(术前平均57分,术后平均87.8分);X线摄片根据Ficat分期标准185侧无骨坏死进展表现,18侧II期病例进展到III期,29侧III期进展到IV期。47例影像学进展病例中的23例行全髋人工关节置换术,其中Ficat II 4例,III期11例和IV期8例;分别于术后16个月至58个月因疼痛不缓解或股骨头进行性塌陷改行人工全髋关节置换术。另外24例中,18例患者Harris评分大于80分,6例患者最近随访时除功能康复治疗以外无其它进一步治疗要求。随访期内行全髋人工关节置换的包括带旋股外侧血管升支髂骨瓣转移术9例;旋股外侧血管升支臀中肌支大转子骨瓣转移术6侧;带旋股外侧血管横支的大转子骨瓣5例;联合带旋股外侧血管横支、升支臀中肌支大转子骨瓣3例。本组病人临床成功率为87.5%,影像学成功率为79.7%。56例术后DSA造影表现,作为血管蒂显影清晰、饱满无中断,其伴随静脉无造影剂淤滞现象。以骨瓣为基底有放散样血管向原坏死骨区域延伸,股骨头染色面积增大,染色时间变短,单位面积内血管数量增加,静脉回流显影提前,回流障碍得到了明显改善。提示股骨头血运得到了恢复,微循环开始重新建立。2例DSA造影血管蒂显影不良的病例末次随访评价中分期无影像学进展,Harris评分分别为82、85分。生存分析:应用Kaplan-Meier法进行生存分析,以任何原因所导致的关节置换为截尾数据。该组病例总生存率为90.09%,其中Ficat II 期生存率为96.49%,平均生存时间58.46月(95%可信区间,56.98~59.94月);Ficat III 期生存率为88.54%,平均生存时间57.50月(95%可信区间,55~60.1月),Ficat IV 期生存率为63.64%,平均生存时间47.23月(95%可信区间,42.22~52.25月);其中Ficat II期与Ficat III期生存率比较无统计学意义(P=0.0564),Ficat IV期与Ficat II、III期比较均有统计学意义(P<0.0001,P=0.0084),(图1)。根据不同手术方法,带旋股外侧血管升支髂骨瓣转移术生存率为89.16%;旋股外侧血管升支臀中肌支大转子骨瓣转移术90.91%;带旋股外侧血管横支的大转子骨瓣转移术90.74%;联合带旋股外侧血管横支、升支臀中肌支大转子骨瓣转移术89.66%,四种疗法的生存时间差异无显著性意义,各组的总体水平比较无统计学意义(P=0.9594)(图2、3、4、5、6、7、8)。讨论股骨头缺血性坏死是骨科领域中至今尚未解决的疑难疾病之一,目前本病的发病有年轻化的趋势,如果未经及时、有效治疗大多数患者病情将进行性发展,并最终导致严重的髋关节骨性关节炎,使病人丧失劳动能力。对晚期患者,人工全髋关节置换术作为一项成熟和经典的骨科治疗技术已经在髋关节疾病的治疗中取得了巨大的成功,但并不适合中青年患者。对于ONFH的治疗,争论的焦点主要集中于Ficat II-III期,对于Ficat I期的髓芯减压和Ficat IV期的关节成形术已经被国内外学者普遍接受[4,5,6]。各种针对Ficat II-III期的治疗由于分期、愈后评价和远期随访存在着诸多差异,还没有一种治疗方法能够被广泛的接受[7]。在ONFH病因未被彻底揭示前,治疗的重点在于如何准确判断本病的病程以及受累的范围,采用操作相对简单而效果确切的方法来阻止本病的进一步发展,延迟或最终避免人工关节置换。带营养血管的骨组织瓣移植由于从纠正ONFH的病理生理改变入手,既重建股骨头的血液循环又提供可替代坏死骨质的活骨,经临床应用已经显示出较大的优越性,并有可能成为保留股骨头的主要手术治疗方法。目前应用的这类方法有两类:一是吻合血管的游离腓骨移植术;一是带血管蒂的骨(膜)瓣转移术。传统的手术方法创伤大,对股骨头的血运可能会进一步的破坏。因此,微创理念的建立就尤其重要。本组病例均采用切口小于11厘米的微创手术方法行带血管蒂的骨瓣转移术。经早中期随访,临床和影像成功率满意,Ficat II,III期骨瓣的生存率较高,为96.49%,88.54%。1.微创化带血管蒂骨瓣转移术的特点带血管蒂的骨瓣或骨膜瓣移位术由于无需进行显微吻合,因而更易普及推广,移植的骨瓣带有独立的动静脉系统,可与病灶周围的血运建立联系,重建股骨头内的血液供应[8,9]。微创化带血管蒂骨瓣转移术的突出优点是对髋周组织干预小,于肌间隙进入,不损伤髋屈曲及外展功能,术后疼痛轻,切口美观,恢复快,手术时间和术中失血较传统的骨瓣转移术没有明显差异。即使失败也不会对全髋关节置换产生不良影响[10],考虑到青壮年病人进行人工关节置换后必将面临翻修手术的巨大心理压力和经济负担,因而进行股骨头的修复与再造仍不失为一种有退路的治疗选择。然而值得注意的是,该术式要求术者对髋周解剖熟悉,术中根据血管状况选取适当的带血管蒂的骨瓣,而不应因追求小切口,而将手术程式化,勉强选用骨瓣,最好的术后功能康复应该应是手术的目标。2.微创化带血管蒂骨瓣转移术的适应症和禁忌症并非所有的ON FH 患者均适用微创的骨瓣转移手术,选择合适的患者才能获得良好的疗效。适应证为: ①体重指数小于30; ②病变位于前侧或前外侧的Ficat II-III期病例 ③术前影像学评估,血管条件良好,解剖位置无较大变异。④术者对常规的骨瓣转移术有丰富的经验,入路清晰。⑤具备必要的设备, 如特殊拉钩等。相对禁忌证: ①体重指数大于 30,尤其是肌肉发达的男性和肥胖患者; ②二次手术者(不包括髓芯减压术) ; ③髋关节已强直,晚期骨关节炎表现的FicatIV期患者(本组Ficat IV期临床生存率仅为63.64%)。3.微创化带血管蒂骨瓣转移术的技术要点良好的暴露是手术成功的前提,尽量减小切口长度和对髋周组织的侵袭。但不应盲目追求小切口而增加对皮肤和软组织的过度牵拉。手术应熟悉髋关节、旋股外侧血管的解剖,有条件可常规术前血管造影以确定血管位置,术前选择血管条件较好的作为血管蒂将大大提高手术的成功率,减少手术时间和术中出血。该方法主要适用于Ficat分期Ⅱ、Ⅲ期的中青年患者,经临床早中期随访,对于已出现骨性关节炎表现的Ficat IV期病例,临床成功率相对效低。对于60岁以上的老年患者应慎用,因老年人成骨能力差且多存在血管内膜病变,故手术失败率较高。术中游离升支臀中肌支血管时,避免损伤臀上神经,以免术后臀中肌瘫痪;切取骨瓣时要尽可能保持臀中肌止点的完整性,切取的肌肉仅限前外侧下端的小部分臀中肌。手术应注意避免血管蒂扭转及痉挛,术后常规采取保障血管蒂通畅的治疗措施。参考文献1.Mont M A, Jones L C, Hungerford DS.Nontraumatic Osteonecrosis of the Femoral Head: Ten Years Later. 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对于股骨头缺血性坏死的治疗,由于医师自身诊治水平的不足,出现很多认识上的误区:一方面为迎合病人惧怕手术的心理,一味采用中医中药方法进行保守治疗,致使很多病人失去了保留股骨头的最佳手术时机;另一方面,很多医生对于ONFH的患者一律进行人工关节置换,而并没有充分考虑年龄和病变分期,使后期的并发症很难处理。所以提高ONFH的诊治水平,严格掌握治疗的适应症是我们应该强调的重要问题之一。 ◎韦氏活骨I号治疗股骨头缺血性坏死 近年来随着对股骨头缺血性坏死的发病机理研究的不断深入,血管内凝血学说越来越得到多数学者的认同,认为血管内凝血这一中间机制,可能成为各种病因的最后共同通路,从而引起非创伤性骨坏死。这与祖国医学对骨坏死病因的阐述不谋而合,中医认为各种原因导致的骨坏死的病理特点都是因为气血不通,瘀滞而产生“瘀血”。气血对骨的滋养是骨骼能保持正常形态和正常功能的关键,而一旦瘀血阻滞,脉络不通,气血失去滋养,骨则必然会枯朽、塌陷、坏死。“脉络不通,不通则痛”,综合骨坏死病人骨痛、功能障碍等症状,莫不与此符合。这与中医的“气血不行,气滞血瘀”的观点是一致的。 经多年临床实践,我们研制了韦氏活骨Ⅰ号胶囊,其方中选用黄芪即能补气助阳推动血脉运行,又能增强体能;当归补血,活血,与丹参,红花配伍增强活血化瘀之功;延胡索行气化瘀止痛,与乳香,没药合用共奏活血止痛,消肿生肌之效;麝香味辛,性温,芳香走窜,通行十二经,能开窍通络,活血化瘀,又能消肿生骨。诸药合用,使气血双补,促进局部血液循环,改善骨血供,舒通经络,化瘀生新,加速新骨的生成,达到标本兼治的目的。自1995年至今,我们已应用于股骨头缺血性坏死早期患者1000余例,有效避免或延缓了病人的手术治疗,对于早期患者治疗愈率达90%。 ◎股骨头缺血性坏死的综合治疗 保守治疗的主要目的是减少或避免股骨头负重,以待股骨头骨质自身修复,防止股骨头软骨面的塌陷,同时应用抗凝,扩张血管及补钙药物,促进股骨头内的血液循环,增加股骨头血供,促进股骨头内的骨质修复。保守治疗适应于股骨头缺血性坏死ARCO分期Ⅰ期或Ⅱ期早期患者。对于股骨头内有大的囊变及死骨的Ⅱ期晚期患者,保守治疗很难使囊变消失,死骨亦难爬行替代,因为这些死骨常被新生骨小梁包裹,破骨细胞难以达到。Ⅲ期患者保守治疗亦不能使塌陷的软骨再次腾起,与Ⅳ期患者一样是保守治疗的禁忌症,只能采取手术彻底治疗。保守治疗根据文献报道及我们治疗经验,效果欠理想,有报道非手术治疗只有24%股骨头能保持2~3年的正常外形,其余76%均出现股骨头塌陷。 我们采取的综合治疗方法是: (1)卧床,患肢避免负重皮牵引1个月,牵引重量2~4kg,之后扶双拐下地,3个月内患肢不能负重。 (2)应用抗凝、扩血管、扩容药物 静脉滴注低分子右旋糖酐注射液500ml,复方丹参注射液16ml,也可使用凯时注射液10~20ug,加入生理盐水或葡萄糖中静点,上述药物连续应用3周。并同时服用韦氏活骨I号胶囊。 (3)高压氧治疗 10天为一个疗程,可连续2~3个疗程,治疗期间应注意氧中毒等并发症。 治疗期定期复查X线片,有条件的患者可复查CT,一旦发现坏死加重,则应立即放弃保守治疗,尽快手术,以防股骨头塌陷病情进一步加重。