骨水泥聚乙烯内衬技术的临床与生物力学研究
摘要
研究背景
全髋人工关节置换术成功开展数十年,用于治疗多种晚期髋关节疾病包括骨关节炎、类风湿性关节炎、股骨头缺血性坏死、髋臼发育不良等,手术技术日臻成熟,大宗病例证实疗效肯定,已成为临床常用的标准手术之一。1971年Harris首次采用模块化假体,促进了各类材料、界面组合的发展,为关节外科医师提供了更多的选择,同时也带来了内衬磨损、分离、假体不稳等并发症。过去20年多数人工全髋关节置换术采用金属或陶瓷对聚乙烯界面,由于传统聚乙烯的特点,容易发生聚乙烯磨损,磨损颗粒引起假体周围骨溶解,随之人工假体无菌性松动、下沉、移位。骨溶解和假体松动是影响人工全髋关节置换术远期疗效的主要原因。磨损及其引起的一系列生物学反应是造成骨溶解和假体松动的主要因素及机制。源于聚乙烯内衬磨损导致的假体松动是髋臼翻修的主要原因之一。
人工髋臼翻修术主要有两种方式：髋臼假体松动时行全髋臼翻修,在骨缺损处植骨已成为共识；对于金属髋臼稳定伴有聚乙烯内衬磨损和髋臼假体周围程度不一的骨溶解的病例,选择取出金属髋臼还是单纯更换内衬仍存在争论。后者主要适用于金属髋臼稳定、聚乙烯内衬磨损伴骨溶解或内衬失败的病例,优点是手术损伤较小、出血少、手术时间短、保留患者髋臼骨量,可同时行清除磨损碎屑及界膜组织,并通过髋臼螺钉孔植骨或者在患者髋臼开窗植骨治疗骨溶解,避免全髋臼假体翻修可能导致的患者髋臼骨缺损、骨盆不连续,降低患者费用、减少手术致残、致死率。
更换聚乙烯内衬有两种方式：1、单纯更换新聚乙烯内衬；2、用骨水泥将新聚乙烯内衬固定于原金属髋臼内,可称为骨水泥聚乙烯内衬技术,亦有作者称之为“双杯”技术(Double-socket technique)。前者常由于锁定装置损坏、新聚乙烯内衬不匹配、难以找到原型号内衬等原因而难以实现；而后者用骨水泥将新内衬固定于原金属髋臼内解决上述问题,此外可使用含抗生素骨水泥减少翻修术后感染,可改变假体界面,例如使用金属内衬,还可以在原金属髋臼允许范围内选择不同大小的内衬,但其选择由于对内衬厚度及股骨头直径的要求而有所限制。
骨水泥聚乙烯内衬技术在患者的应用由Heck与Murray于1986年首次报道,此后得到广泛应用与研究。生物力学研究表明聚乙烯内衬-骨水泥-金属髋臼界面的固定强度优于或相当于髋臼标准锁定装置,骨水泥-金属髋臼界面未见失败记录,对聚乙烯内衬外表面的处理及水泥层厚度有较一致的结果。临床病例经过中短期随访,临床及影像学结果良好。更换聚乙烯内衬及股骨头可以减少磨损,减缓骨溶解进展,更换内衬尤其是使用高交联聚乙烯内衬替换原传统聚乙烯内衬后,高交联聚乙烯磨损率降低,陶瓷对聚乙烯或金属对聚乙烯界面产生磨损颗粒减少,骨溶解进展减缓,联合金属髋臼螺钉孔或者开窗骨溶解区病灶清除异体骨植骨可以清除骨溶解区域界膜组织、减少局部磨损颗粒、填充骨溶解区域,恢复患者髋臼周围骨量。但该手术技术并发症不容忽视：15%-30%的脱位发生率；骨水泥聚乙烯内衬技术不能改变金属髋臼外倾、前倾角度,对于位置不良的金属髋臼,如：后倾或者过度外倾的金属髋臼,更换聚乙烯内衬术后可能出现关节不稳；该手术技术增加了聚乙烯内衬-骨水泥-金属髋臼界面,可能增加界面分离的风险；手术入路对术后关节脱位的发生有一定的影响。
对合适的患者选择合适的手术方式是取得手术成功的关键。目前骨水泥聚乙烯内衬技术主要应用于聚乙烯内衬磨损、股骨头穿透内衬、金属髋臼锁定装置损坏、没有匹配原金属髋臼聚乙烯内衬的病例,对于伴有髋臼假体周围骨溶解的病例,要制定个体化的治疗策略。如局限性骨溶解病灶,可以更换聚乙烯内衬联合骨溶解病灶清除加异体骨植骨；广泛的骨溶解或连续的髋臼假体周围透亮线应考虑全髋臼翻修；如髋臼假体使用时间较长,需查阅关于该种假体寿命的记录作为参考；如患者有人工髋关节不稳定的历史,聚乙烯内衬更换需慎重；而对于髋臼假体位置不良但稳定的病例,由于单纯更换聚乙烯内衬术后脱位风险较高,目前认为以全髋臼翻修为佳。
人工髋臼位置不良并不少见,如中立位或后倾放置、过度外倾,人工全髋关节置换术中过分追求髋臼外上方的骨性包容,虽然骨组织对金属髋臼覆盖满意,但容易发生髋臼外倾角过大,导致聚乙烯内衬外上方的磨损。对于这类病例,采用骨水泥聚乙烯内衬技术将新的聚乙烯内衬放置于较佳的髋臼外翻角度是否可行与可靠,是一个非常实用的研究课题。在这种情况下,聚乙烯内衬非高边赤道面与金属髋臼的赤道面出现交角,两者之间的水泥层能否提供足够的固定强度,目前尚无报道。人工全髋关节置换术后金属髋臼外倾角度过大的发生率也需要进一步调查。能否将骨水泥聚乙烯内衬技术指征扩大,使金属髋臼固定牢固、外倾角度过大的患者避免全髋臼假体翻修,为远期翻修手术保留骨量,令这部分患者受益呢?有必要对骨水泥聚乙烯内衬技术作进一步的研究。
目的
1、对全髋关节置换术后患者进行随访,了解髋关节Harris评分由患者自评的结果与医师评分有无差异。调查人工全髋关节置换术后髋臼假体外倾角≥50。与≥55。的发生率及髋臼外倾角与聚乙烯内衬线性磨损的关系,探讨固定稳定、位置不良的金属髋臼应用骨水泥聚乙烯内衬技术的必要性。
2、了解骨水泥聚乙烯内衬技术应用于聚乙烯内衬翻修时聚乙烯内衬-骨水泥-金属界面的生物力学强度；评估金属髋臼与聚乙烯内衬存在交角时,聚乙烯内衬-骨水泥-金属界面能否提供与标准锁定装置相当或更大的固定强度。使聚乙烯内衬外表面“纹理化”处理简单化,并对简单“纹理化”的聚乙烯-骨水泥界面力学强度作出评价。评估聚乙烯内衬中心化的效果。
3、初步探讨骨水泥聚乙烯内衬技术用于聚乙烯髋臼翻修的技术要点、可行性,并观察手术早期效果。
方法
1、临床调查：对1993年1月至2006年5月在广医一院所行全髋关节置换术147例165髋进行随访,医生对获得随访的32例36髋进行Harris评分,并由患者对自身做Harris评分,两组资料作配对t检验。选取2011年5月前我院骨外科所行126例145髋人工全髋关节置换术的末次随访骨盆前后位X线片,由放射科医师及骨科医师测量髋臼外倾角,采用配对t检验比较两者测量结果有无差异；统计外倾角≥50。及≥55。的发生率。测量聚乙烯内衬线性磨损值,采用线性回归分析评估外倾角大小与聚乙烯内衬线性磨损值的相关性,比较外倾角<50。与≥50。时聚乙烯内衬线性磨损值的差异,比较内衬使用时间<5年与大于5年聚乙烯内衬线性磨损值的差异。
2、生物力学实验：抗杠杆力实验组：25对金属髋臼及聚乙烯内衬假体随机平均分为5组,以标准锁定装置组作为对照组,其余4组应用骨水泥聚乙烯内衬技术在聚乙烯内衬与金属髋臼不同交角(0。,10。,20。)下固定聚乙烯内衬,分为无钢珠聚乙烯内衬与金属髋臼0。交角组、带钢珠聚乙烯内衬与金属髋臼0。交角组、带钢珠聚乙烯内衬与金属髋臼10。交角组、带钢珠聚乙烯内衬与金属髋臼20。交角组(分别简称为无钢珠0。组,0。交角组,10。交角组,20。交角组)。部分组别在固定聚乙烯内衬时在聚乙烯内衬外表面放置4个2mm直径球形钢珠,使骨水泥层厚度均匀。通过生物力学杠杆实验,测定各组界面抗杠杆力强度。抗扭转力实验组：25对金属髋臼及聚乙烯内衬假体随机平均分为5组,以标准锁定装置组做为对照组,其余4组应用骨水泥聚乙烯内衬技术在聚乙烯内衬与金属髋臼不同交角(0。,10。,20。)下固定聚乙烯内衬,分为无钢珠聚乙烯内衬与金属髋臼0。交角组、带钢珠聚乙烯内衬与金属髋臼0。交角组、带钢珠聚乙烯内衬与金属髋臼10。交角组、带钢珠聚乙烯内衬与金属髋臼20。交角组(分别简称为无钢珠0。组,0。交角组,10。交角组,20。交角组)。部分组别在固定聚乙烯内衬时在聚乙烯内衬外表面放置4个2mm直径球形钢珠,使骨水泥层厚度均匀。通过生物力学扭转实验,测定各组界面抗扭力强度。“纹理化”聚乙烯内衬组：5对金属髋臼与聚乙烯内衬假体以骨水泥固定,进行生物力学扭转实验。对本组聚乙烯内衬的开孔填充部分骨蜡,在聚乙烯内衬外表面形成榫孔,使骨水泥溢入,形成聚乙烯内衬与骨水泥之间的“咬合”。测定其界面抗扭力强度与扭转实验中标准锁定装置组比较,评估简单“纹理化”聚乙烯内衬采用水泥固定后的抗扭力强度。
3、对2例髋臼翻修术采用骨水泥聚乙烯内衬技术更换内衬,进行短期随访,观察临床及影像学结果。
结果
1、末次随访医师Harris评分为90.01±7.75分(68.5-100分),排除“体征”及“活动范围”两部分内容后的医师评分为：83.39±7.591(62-91分),患者自评为84.36±6.974(66-91分),采用配对样本t检验,t=-0.1567,P=0.126,差异无统计学意义。关节外科与放射科医师所测髋臼外倾角均数分别为47.56。+8.826。、48.41。±9.395。,配对样本t检验显示t=2.978,P=0.003,差异有统计学意义。髋臼外倾角≥55。的百分率为22.1%(32/145,15.3%-28.9%),髋臼外倾角≥50。的百分率为42.1%(61/145,34.1%-50.1%)。所有聚乙烯均可见不同程度的磨损,剔除双髋置换病例后,107个单侧全髋关节置换术后聚乙烯内衬线性磨损均值为0.832±0.7069mm。对107个髋的髋臼外倾角与聚乙烯线性磨损值做散点图及简单线性回归分析,采用曲线拟合的方法,结果显示,二次多项式曲线拟合效果较好,拟合优度(R Square)为0.697,聚乙烯线性磨损值与髋臼外倾角同向相关,其回归方程为y＝4.431-0.21x+0.003x2。
2、生物力学实验：抗杠杆力实验组：各组抗杠杆力分别为无钢珠0。交角组915.04±197.49N、0°交角组449.02±119.78N、10。交角组814.68±53.89N、20。交角组1033.05±226.44N、标准锁定组626.68±206.12N,各组样本的总体方差齐性一致,单因素方差分析显示F为8.989,P<0.001,提示各组间抗杠杆力存在差异。20。交角组、10。交角组、无钢珠0。交角组抗杠杆力均大于标准锁定组。LSD法以标准锁定组为对照组比较与其他各组的差异,发现标准锁定组与20。交角组(P=0.001)、无钢珠0。交角组之间(P=0.016)的比较有统计学差异,P值均小于0.05。与10。交角组比较,P＝0.102,无统计学差异。与标准锁定组比较,0。交角组的抗杠杆力较弱,P值为0.121,两组间没有统计学差异。抗扭转力实验组：各组最大扭矩分别为：无钢珠0。交角组6.39±1.03Nm,0。交角组7.60±1.73Nm、10。交角组7.01±2.25Nm、20。交角组7.32±1.56Nm、标准锁定组23.82±3.78Nm。Levene检验各组样本的总体方差不齐,单因素方差分析显示F=50.859,P<0.001,提示各组间抗扭力扭矩存在差异。采用Gamse-Howell法比较两两组间差异,显示标准锁定组与其他各组比较有统计学差异,P值均等于0.001,其余各组间两两比较没有差异。标准锁定装置显示了较强的抗扭转性能。“纹理化”聚乙烯内衬组：纹理化组：31.03±1.58Nm,标准锁定组23.82±3.78Nm,采用独立样本t检验比较两组均值,两组间方差不齐,F=6.277,P=0.037,独立样本t检验显示t=-3.94,P=0.01,差异有统计学意义。
3、2个采用骨水泥聚乙烯内衬技术更换内衬的全髋关节翻修病例,其髋关节Harris评分分别由术前的53分、66分提高到随访时的97分、97.5分,手术效果满意,无并发症。骨盆及髋关节照片未见髋臼松动及新骨溶解区,植骨生长良好。
结论
1、Harris评分表可制作成临床问卷调查,作为全髋关节置换术后临床随访工作的有益补充。人工全髋关节置换术后髋臼外倾角角度过大有一定的发生率,髋臼外倾角过大是聚乙烯内衬磨损的重要因素之一,初次手术中需要采取有效措施防止髋臼假体外倾角过大。由于髋臼前倾角没有统计,结合髋臼假体外倾角过大的发生率,金属髋臼假体位置不良的发生率不能低估,对其中金属髋臼稳定者行更换聚乙烯内衬翻修,并将聚乙烯内衬以骨水泥固定于正常位置是否可行及可靠,需要进一步研究。
2、生物力学实验：抗杠杆力实验组：与标准锁定装置相比,聚乙烯内衬与金属髋臼之间存在交角时用骨水泥固定,能够提供足够的早期固定强度。抗扭转力实验组：与标准锁定装置相比,聚乙烯内衬与金属髋臼之间以骨水泥固定强度减弱,这与研究采用的聚乙烯内衬外表面光滑、没有纹理化有关,需要对聚乙烯内衬外表面做“纹理化”提高其抗扭转性能。聚乙烯内衬外表面简单的“纹理化”处理加强了聚乙烯-骨水泥界面的抗扭转能力,结果优于标准锁定装置的固定强度。本研究中对聚乙烯内衬外表面纹理化的简单处理可作为研制新型聚乙烯内衬的参考。
3、骨水泥聚乙烯内衬技术上是可行的,手术效果显著,手术操作有其特点,相对于全髋臼翻修创伤小,恢复快,可保留宿主髋臼骨量,延缓全髋臼翻修,是髋臼翻修术中一个可选择的术式。
主要创新点
提出骨水泥内衬改向技术理念,应用于金属髋臼稳定、位置不良时的内衬改向翻修,并对内衬改向翻修的固定强度进行生物力学研究,目前尚未见报道。
Background
Total hip arthroplasty (THA) has been used, successfully and effectively, for the treatment of various advanced stage hip diseases, such as osteoarthritis, rheumatoid arthritis, congenital acetabular dysplasia, avascular necrosis of the femoral head for decades. Harris firstly reported a modular prosthesis in1971, which promoted the development of various materials and the interface combination, and provided surgeons more choices, but also brought wearing, separation, loosen of prosthesis and other complications. Over the past20years, most of THA were composed of metal or ceramic head and traditional polyethylenes (PE) liner. The worn liner, periprothetic osteolysis and prosthesis aseptic loosening resulted from PE particles, were the main reasons of revision.
There are mainly two kinds of techniques in acetabular prosthesis revision, total acetabular revision and isolated acetabular liner exchange. Total acetabular revision with bone grafting if necessary, become a consensus in management of acetabular loosening. For the stable metal acetabular cup with worn liner and various degree of periprothetic osteolysis, the choice of total acetabular revision or liner exchange remains controversial. Lots of surgeons prefer to liner exchange, for which have the advantage of mimic invasive, less bleeding, time and cost effective, bone reservation, eliminating wearing particles and membrane at the same time. Osteolysis can be treated by allograft bone grafting through acetabular screw holes or by fenestration. Liner exchange can avoid acetabular bone defect and pelvic discontinuity, reduce operation disability and mortality rate.
Liner exchange can be divided into simple liner exchange and cemented liner technique. The later which is so-called double-socket technique means a liner was fixed into the original metal acetabular cup with cement. Simple liner exchange is often difficult to carry out because of a damaged locking mechanism (by wear, fatigue or trauma), lack of a replacement liner in desire material or size, and so on. While cement liner technique that fixed a new liner into the original metal acetabular cup with cement, can not only avoid the problems above, but also prevent revision from infection by using antibiotics cement. Cement liner technique can change prosthesis interface to metal liner or other material. Liner with different sizes can be chosen to cement in the original acetabular cup, concerning about the diameter of the femur head and the thickness of liner.
Cemented liner technique in clinical was firstly reported by Heck and Murray in1986and then spreaded worldwide in extensive research and clinical application. Biomechanical studies suggested that the interface fixation of liner-cement-metal acetabular cup was stronger than or comparable to the acetabular standard locking mechanism. Meanwhile, cemented liner technique had also achieved excellent results in clinical or radiographic follow up. The replacement liner, especially the highly cross-linked polyethylene liner could prevent patient from progress or recurrence of osteolysis because of low wear rate and reduce wear particles generated from polyethylene-on-ceramic or polyethylene-on-metal interface. Combined with allograft bone grafting through screw holes or by fenestration in osteolysis area to remove the interface membranes, wear particles and granulation tissue, eliminate osteolysis and recover the bone mass of host acetabulum, cemented liner technique can also promote bone ingrowing with the porous surface of acetabular cup. Although cemented liner technique achieved excellent results, its complications could not be ignored. The rates of hip dislocation after revision were high (range,15%-30%) for several reasons. This technique was limited to the direction of previous acetabular cup. Cemented liner in the acetabular cup of retroversion or excessive abduction made the hip in high risk of dislocation and interface separation. Some authors believed that there were some correlation between dislocation after revision and operative approach. The posterior approach debridement of scar and resection of joint capsule might lead to dislocation, while there was an extremely low rate of hip dislocation in liner revision using lateral or anterior approach.
The proper choice of indication is critical for operation. Cemented liner technique is mainly for the management of the stable acetabular cup with liner wear, damage of locking machanism, lack of liner to match the original acetabular cup. Sometimes, the indications were relative. The healing strategy were adjusted accordingly, such as the local osteolysis need liner revision combined with allograft bone grafting in the osteolysis zone, while extensive or periprosthetic osteolysis should be considered the total acetabular revision. If the acetabular cup had been used for a long time which approach to the prosthesis longevity, the total acetabular revision may be a proper choice, otherwise, cementing a liner will be a good selection. If a patient has a history of dislocation or a mal-positional acetabular cup in his artificial hip joint, liner replacement should be careful for the high risk of dislocation. Most of surgeons prefered to choose total acetabular revision in this condition.
Malposition of artificial acetabulums, such as neutral or backward place, excessive abduction of the metal acetabular cups, is a common defection. Excessive abduction result from seeking osseous containment for getting a satisfactory fixation of acetabular cup, increase liner wear at upper parts. For such cases, whether it is feasible and reliable that a new liner cemented and rolling in an unsatisfied acetabular cup till to a correct abduction or anteversion angle is not reported in our knowledge but a practical topic.
Therefore, we focus our attention on this topic to provide whether cemented liner technique is suitable for such cases for avoiding total acetabular revision preserving bone mass and preventing patient from dislocation.
Objective
1. To compare hip Harris score between surgeon's result and patients' self-evaluation. To access the correlation between abduction angle of acetabular cup and the liner wear, investigate the incidence rate of excessive abduction acetabular cup (≥50°,≥55°), and illustrate the necessity of cemented liner technique in the stable but dys-directional acetabular cup.
2. To evaluate the strength of liner-cement-metal cup interface in cemented liner technique, and assess whether the interface fixation of liner-cement-metal cup is more strength than or equivalent to the acetabular standard locking mechanism when there is a cross angle between metal cup and polyethylene liner. Simply textured at outer surface of the polyethylene liner to strengthen interface stability, and estimate the reinforce effect of the polyethylene-cemented interface. To evaluate the effect of cementing a polyethylene liner in the center of acetabular cup.
3. To investigate the technical key points, feasibility and observe the early clinical effect of the technique that cementing a polyethylene liner into acetabular cup in hip revision.
Methods
1. Clinical investigation:32cases out of147patients(165hip) who were underwent THA in the First Affiliated Hospital of GuanZhou Medical College from January,1993to May,2006, have been performed Harris score by doctors and patients themselves, and the mean of which were compared by using pair-samples T test. Clinical retrospective analysis was performed in147patients (47male,80female) with a mean age60.2years (range,23-85years) who were underwent THA in the First Affiliated Hospital of GuanZhou Medical College before May2011. The anteroposterior films of pelvic were obtained by digital radiography in post-operation and follow-up to measure the abduction angle of acetabular cup by orthopedist and radiologist. Two groups of results were compared, and the incidence of excessive abduction angle greater than50°and55°were also calculated. Meanwhile, the linear polyethylene wear were measured on unilateral THA to access the correlation between abduction angle of acetabular cup and liner wear. Furthermore, the linear wear value of the polyethylene liner were compared between groups of abduction angle<50°and≥50degree, groups of using period less than5years and exceed5years.
2. Biomechanical study:The lever-out test:25pair metal acetabular cups with polyethylene liners were randomly divided into5groups. One group with standard locking mechanism as control group, other liners were cemented into acetubular cups as experimental groups. According to the different intersection angle of metal acetabular cups with polyethylene liners and the polyethylene liners with/without metal ball, the four experimental groups were:no ball0degree group which is metal acetabular cups intersected with polyethylene liners(without metal ball) at0degree angle,0degree group which is metal acetabular cups intersected with polyethylene liners(with metal ball) at0degree angle,10degrees group which is metal acetabular cups intersected with polyethylene liners(with metal ball) at10degree angle,20degrees group which is metal acetabular cups intersected with polyethylene liners(with metal ball) at20degree angle. In order to obtain an even thickness of cement mantle, four balls of2mm diameter were placed between metal cup and polyethylene liner when liners were cemented. The lever-out biomechanical test was then performed at each group to evaluate the lever-out failure strength of liner-cement-metal cup interface. The torsion test:other25pairs metal acetabular cups with polyethylene liners were also randomly divided into5group. One group with standard locking mechanism group as control group, the others were prepared to imitate cementd liner technique as experimental groups. According to the different intersection angle of metal acetabular cups with polyethylene liners and the polyethylene liners with or without metal ball, four experimental groups were:non-ball0degree group stood for metal acetabular cups intersected with polyethylene liners(without metal ball) at0degree angle,0degree group stood for metal acetabular cups intersected with polyethylene liners(with metal ball) at0degree angle,10degrees group which is short for metal acetabular cups intersected with polyethylene liners(with metal ball) at10degree angle,20degrees group stood for metal acetabular cups intersected with polyethylene liners(with metal ball) at20degree angle. In order to obtain a uniform thickness of cemented shell, four balls of2mm in diameter were placed between metal cup and polyethylene liner while fixate liner with cement. The torsion test was also performed at each group to determine the anti-torsion strength of the liner-cement-metal cup interface. Texture reinforce test:10holes were made at the outer surface of5polyethylene liner (2symmetrical holes for each liner) by drill of3mm in depth. Therefore the polyethylene liner was interlocked with cement mantle after cement filled into the hole. Then the ant-torsion strength of the textured liner-cement-metal cup interface were tested and evaluated by comparing with the ant-torsion strength of the standard locking mechanism group.
3. Cementing polyethylene liner into acetabular cup was performed in hip revision in two cases, and a short-term follow-up was carried out to get clinical and imaging findings.
Results
1. The clinical investigation results:In the final follow up, the mean Harris score evaluated by doctors was90.01±7.75points (range,68.5～100points), while take out the score of physical sign and action range, the mean Harris score was83.39+7.591points (range,62～91points) evaluated by doctors VS84.36+6.974points (range,66～91points) evaluated by patients themselves. No significant difference was found between the two groups(t=-0.1567, P=0.126). The mean acetabular abduction angle was47.56°±8.826°measured by joint surgeon VS48.41°±9.395°measured by radiologist, there was statistical difference (t=2.978, P=0.003). Out of145THA, there were32acetabular metal cups with an abduction angle greater than55degrees (15.3%～28.9%), and61acetabular metal cups with an abduction angle greater than50degrees (34.1%～50.1%). The mean of linear wear of polyethylene liner in107patients with unilateral THA was0.832±0.7069mm.A scatter diagram was made to reveal the relationship between abduction angle and liner wear in107unilateral THA, and then a curve estimation was taken by SPSS13.0. R square was up to0.697using Quadratic curve. Regression equation was y=4.431-0.21x+0.003x2.
2. The results of lever-out test:loading on the same moment arm, the mean±sem liver-out failure force were respectively:non-ball0degree group,915.04±197.49N;0degree group,449.02±119.78N;10degrees group,814.68±53.89N; and20degrees group,1033.05±226.44N; while the standard locking group,626.68+206.12N. ANOVA showed significant difference between each mean lever-out force(F=8.989, P<0.001). The lever-out failure forces of20degrees group,10degrees group, non-ball0degree group, were greater than the standard locking group. Using LSD method, the standard locking control group as a control group were compared with each group, the standard locking control group VS20degrees group (P=0.001), VS non-ball0degree group(P=0.016), the mean lever-out failure force of20degrees group and no ball0degree group were significantly greater than the the standard locking control group(P<0.05); while the the standard locking control group VS10degrees group (P=0.102), VS0degree group(P=0.121), the lever-out failure forces were no statistically significant difference between the two groups. The results of torsion test:the mean±sem torsion failure torque were respectively:non-ball0degree group,6.39±1.03Nm;0degree group,7.60±1.73Nm;10degree group,7.01+2.25Nm;20degree group,7.32±1.56Nm; the standard locking group,23.82±3.78Nm. ANOVA showed significant difference between each mean torsion torque(F=50.859, P<0.001). Using Games-Howell method, the standard locking control group were compared with each group, the mean torsion failure torque of the standard locking control group were significantly greater than every experimental group (P=0.001), but no statistically significant difference was found between any two of the experimental groups. Texture reinforce results:the mean torsion torque were:the textured liner group,31.03±1.58Nm; the standard locking control group,23.82±3.78Nm. Using independent sampler T-test, the mean torsion torque were compared between two groups, and the mean torsion torque of the textured liner group was significant greater than the standard locking control group(t=-3.94, P=0.01).
3. The Harris score of two cases were improved respectively from53,66before operation to97,97.5at final follow up, the operative result was satisfactory, no complication was find, the allograft bone was replaced well by new bone, meanwhile, no acetabular cup loosening and new osteolysis area were detected in the radiograms of pelvis and hip joint.
Conclusion
1. Harris score can be used as a clinical questionnaire, it was a helpful supplementary for clinical follow-up. The incidence rate of excessive abduction acetabular cup were relatively high in THA, the excessive abduction angle of acetabular cup was positively correlative to linear wear of polyethylene liner,and the excessive abduction of acetabular cup should be avoided in primary THA for which was relative to wear of polyethylene liner. The incidence rate of metal acetabular cup with should not be ignored due to the high rate of excessive abduction acetabular prosthesis, if the retroversion of acetabular prosthesis which was not measured in the study was take into consideration, the incidence rate of malposition metal acetabular cup will be increased. The feasibility and reliability of the technique that cemented polyethylene liner with correct direction into a stable but improper orientation metal acetabular cup were still need a further study.
2. Comparing to standard locking mechanism, cementing a liner into a metal cup has similar resist strength to lever-out force, but less resist strength to torsion result from the sooth outer surface of polyethylene liner without texture, therefore, interface reinforcement by texture at the outer surface of polyethylene liner were need to improve the resist strength to torsion. The management of simple texture at the outer surface of the polyethylene liner can increase ant-torsion strength of the liner-cement interface, the interface fixation strength were also slightly better than the standard locking mechanism. The simple texture way at the outer surface of the polyethylene liner used in the study can be consulted to the design of new polyethylene liner.
3. Bone cement polyethylene liner technique is feasible, effective and simple. Comparing to total acetabular revision, it is less trauma, recoverying quickly, retaining more bone mass of acetabulum, delaying the total acetabular revision acetabular revision surgery, so it is an alternative technique for acetabular revision.
The main innovative points
The technical concept of cemented liner direction-adjusting was firstly proposed to cement a new liner in a correct direction into a stable but unsatisfied-directional metal acetabular cup, the interface strength were firstly evaluated in biomechanical test. In our knowledge, these are not reported in literature.
全髋人工关节置换术成功开展数十年,用于治疗多种晚期髋关节疾病包括骨关节炎、类风湿性关节炎、股骨头缺血性坏死、髋臼发育不良等,手术技术日臻成熟,大宗病例证实疗效肯定,已成为临床常用的标准手术之一。1971年Harris首次采用模块化假体,促进了各类材料、界面组合的发展,为关节外科医师提供了更多的选择,同时也带来了内衬磨损、分离、假体不稳等并发症。过去20年多数人工全髋关节置换术采用金属或陶瓷对聚乙烯界面,由于传统聚乙烯的特点,容易发生聚乙烯磨损,磨损颗粒引起假体周围骨溶解,随之人工假体无菌性松动、下沉、移位。骨溶解和假体松动是影响人工全髋关节置换术远期疗效的主要原因。磨损及其引起的一系列生物学反应是造成骨溶解和假体松动的主要因素及机制。源于聚乙烯内衬磨损导致的假体松动是髋臼翻修的主要原因之一。
人工髋臼翻修术主要有两种方式：髋臼假体松动时行全髋臼翻修,在骨缺损处植骨已成为共识；对于金属髋臼稳定伴有聚乙烯内衬磨损和髋臼假体周围程度不一的骨溶解的病例,选择取出金属髋臼还是单纯更换内衬仍存在争论。后者主要适用于金属髋臼稳定、聚乙烯内衬磨损伴骨溶解或内衬失败的病例,优点是手术损伤较小、出血少、手术时间短、保留患者髋臼骨量,可同时行清除磨损碎屑及界膜组织,并通过髋臼螺钉孔植骨或者在患者髋臼开窗植骨治疗骨溶解,避免全髋臼假体翻修可能导致的患者髋臼骨缺损、骨盆不连续,降低患者费用、减少手术致残、致死率。
更换聚乙烯内衬有两种方式：1、单纯更换新聚乙烯内衬；2、用骨水泥将新聚乙烯内衬固定于原金属髋臼内,可称为骨水泥聚乙烯内衬技术,亦有作者称之为“双杯”技术(Double-socket technique)。前者常由于锁定装置损坏、新聚乙烯内衬不匹配、难以找到原型号内衬等原因而难以实现；而后者用骨水泥将新内衬固定于原金属髋臼内解决上述问题,此外可使用含抗生素骨水泥减少翻修术后感染,可改变假体界面,例如使用金属内衬,还可以在原金属髋臼允许范围内选择不同大小的内衬,但其选择由于对内衬厚度及股骨头直径的要求而有所限制。
骨水泥聚乙烯内衬技术在患者的应用由Heck与Murray于1986年首次报道,此后得到广泛应用与研究。生物力学研究表明聚乙烯内衬-骨水泥-金属髋臼界面的固定强度优于或相当于髋臼标准锁定装置,骨水泥-金属髋臼界面未见失败记录,对聚乙烯内衬外表面的处理及水泥层厚度有较一致的结果。临床病例经过中短期随访,临床及影像学结果良好。更换聚乙烯内衬及股骨头可以减少磨损,减缓骨溶解进展,更换内衬尤其是使用高交联聚乙烯内衬替换原传统聚乙烯内衬后,高交联聚乙烯磨损率降低,陶瓷对聚乙烯或金属对聚乙烯界面产生磨损颗粒减少,骨溶解进展减缓,联合金属髋臼螺钉孔或者开窗骨溶解区病灶清除异体骨植骨可以清除骨溶解区域界膜组织、减少局部磨损颗粒、填充骨溶解区域,恢复患者髋臼周围骨量。但该手术技术并发症不容忽视：15%-30%的脱位发生率；骨水泥聚乙烯内衬技术不能改变金属髋臼外倾、前倾角度,对于位置不良的金属髋臼,如：后倾或者过度外倾的金属髋臼,更换聚乙烯内衬术后可能出现关节不稳；该手术技术增加了聚乙烯内衬-骨水泥-金属髋臼界面,可能增加界面分离的风险；手术入路对术后关节脱位的发生有一定的影响。
对合适的患者选择合适的手术方式是取得手术成功的关键。目前骨水泥聚乙烯内衬技术主要应用于聚乙烯内衬磨损、股骨头穿透内衬、金属髋臼锁定装置损坏、没有匹配原金属髋臼聚乙烯内衬的病例,对于伴有髋臼假体周围骨溶解的病例,要制定个体化的治疗策略。如局限性骨溶解病灶,可以更换聚乙烯内衬联合骨溶解病灶清除加异体骨植骨；广泛的骨溶解或连续的髋臼假体周围透亮线应考虑全髋臼翻修；如髋臼假体使用时间较长,需查阅关于该种假体寿命的记录作为参考；如患者有人工髋关节不稳定的历史,聚乙烯内衬更换需慎重；而对于髋臼假体位置不良但稳定的病例,由于单纯更换聚乙烯内衬术后脱位风险较高,目前认为以全髋臼翻修为佳。
人工髋臼位置不良并不少见,如中立位或后倾放置、过度外倾,人工全髋关节置换术中过分追求髋臼外上方的骨性包容,虽然骨组织对金属髋臼覆盖满意,但容易发生髋臼外倾角过大,导致聚乙烯内衬外上方的磨损。对于这类病例,采用骨水泥聚乙烯内衬技术将新的聚乙烯内衬放置于较佳的髋臼外翻角度是否可行与可靠,是一个非常实用的研究课题。在这种情况下,聚乙烯内衬非高边赤道面与金属髋臼的赤道面出现交角,两者之间的水泥层能否提供足够的固定强度,目前尚无报道。人工全髋关节置换术后金属髋臼外倾角度过大的发生率也需要进一步调查。能否将骨水泥聚乙烯内衬技术指征扩大,使金属髋臼固定牢固、外倾角度过大的患者避免全髋臼假体翻修,为远期翻修手术保留骨量,令这部分患者受益呢?有必要对骨水泥聚乙烯内衬技术作进一步的研究。
目的
1、对全髋关节置换术后患者进行随访,了解髋关节Harris评分由患者自评的结果与医师评分有无差异。调查人工全髋关节置换术后髋臼假体外倾角≥50。与≥55。的发生率及髋臼外倾角与聚乙烯内衬线性磨损的关系,探讨固定稳定、位置不良的金属髋臼应用骨水泥聚乙烯内衬技术的必要性。
2、了解骨水泥聚乙烯内衬技术应用于聚乙烯内衬翻修时聚乙烯内衬-骨水泥-金属界面的生物力学强度；评估金属髋臼与聚乙烯内衬存在交角时,聚乙烯内衬-骨水泥-金属界面能否提供与标准锁定装置相当或更大的固定强度。使聚乙烯内衬外表面“纹理化”处理简单化,并对简单“纹理化”的聚乙烯-骨水泥界面力学强度作出评价。评估聚乙烯内衬中心化的效果。
3、初步探讨骨水泥聚乙烯内衬技术用于聚乙烯髋臼翻修的技术要点、可行性,并观察手术早期效果。
方法
1、临床调查：对1993年1月至2006年5月在广医一院所行全髋关节置换术147例165髋进行随访,医生对获得随访的32例36髋进行Harris评分,并由患者对自身做Harris评分,两组资料作配对t检验。选取2011年5月前我院骨外科所行126例145髋人工全髋关节置换术的末次随访骨盆前后位X线片,由放射科医师及骨科医师测量髋臼外倾角,采用配对t检验比较两者测量结果有无差异；统计外倾角≥50。及≥55。的发生率。测量聚乙烯内衬线性磨损值,采用线性回归分析评估外倾角大小与聚乙烯内衬线性磨损值的相关性,比较外倾角<50。与≥50。时聚乙烯内衬线性磨损值的差异,比较内衬使用时间<5年与大于5年聚乙烯内衬线性磨损值的差异。
2、生物力学实验：抗杠杆力实验组：25对金属髋臼及聚乙烯内衬假体随机平均分为5组,以标准锁定装置组作为对照组,其余4组应用骨水泥聚乙烯内衬技术在聚乙烯内衬与金属髋臼不同交角(0。,10。,20。)下固定聚乙烯内衬,分为无钢珠聚乙烯内衬与金属髋臼0。交角组、带钢珠聚乙烯内衬与金属髋臼0。交角组、带钢珠聚乙烯内衬与金属髋臼10。交角组、带钢珠聚乙烯内衬与金属髋臼20。交角组(分别简称为无钢珠0。组,0。交角组,10。交角组,20。交角组)。部分组别在固定聚乙烯内衬时在聚乙烯内衬外表面放置4个2mm直径球形钢珠,使骨水泥层厚度均匀。通过生物力学杠杆实验,测定各组界面抗杠杆力强度。抗扭转力实验组：25对金属髋臼及聚乙烯内衬假体随机平均分为5组,以标准锁定装置组做为对照组,其余4组应用骨水泥聚乙烯内衬技术在聚乙烯内衬与金属髋臼不同交角(0。,10。,20。)下固定聚乙烯内衬,分为无钢珠聚乙烯内衬与金属髋臼0。交角组、带钢珠聚乙烯内衬与金属髋臼0。交角组、带钢珠聚乙烯内衬与金属髋臼10。交角组、带钢珠聚乙烯内衬与金属髋臼20。交角组(分别简称为无钢珠0。组,0。交角组,10。交角组,20。交角组)。部分组别在固定聚乙烯内衬时在聚乙烯内衬外表面放置4个2mm直径球形钢珠,使骨水泥层厚度均匀。通过生物力学扭转实验,测定各组界面抗扭力强度。“纹理化”聚乙烯内衬组：5对金属髋臼与聚乙烯内衬假体以骨水泥固定,进行生物力学扭转实验。对本组聚乙烯内衬的开孔填充部分骨蜡,在聚乙烯内衬外表面形成榫孔,使骨水泥溢入,形成聚乙烯内衬与骨水泥之间的“咬合”。测定其界面抗扭力强度与扭转实验中标准锁定装置组比较,评估简单“纹理化”聚乙烯内衬采用水泥固定后的抗扭力强度。
3、对2例髋臼翻修术采用骨水泥聚乙烯内衬技术更换内衬,进行短期随访,观察临床及影像学结果。
结果
1、末次随访医师Harris评分为90.01±7.75分(68.5-100分),排除“体征”及“活动范围”两部分内容后的医师评分为：83.39±7.591(62-91分),患者自评为84.36±6.974(66-91分),采用配对样本t检验,t=-0.1567,P=0.126,差异无统计学意义。关节外科与放射科医师所测髋臼外倾角均数分别为47.56。+8.826。、48.41。±9.395。,配对样本t检验显示t=2.978,P=0.003,差异有统计学意义。髋臼外倾角≥55。的百分率为22.1%(32/145,15.3%-28.9%),髋臼外倾角≥50。的百分率为42.1%(61/145,34.1%-50.1%)。所有聚乙烯均可见不同程度的磨损,剔除双髋置换病例后,107个单侧全髋关节置换术后聚乙烯内衬线性磨损均值为0.832±0.7069mm。对107个髋的髋臼外倾角与聚乙烯线性磨损值做散点图及简单线性回归分析,采用曲线拟合的方法,结果显示,二次多项式曲线拟合效果较好,拟合优度(R Square)为0.697,聚乙烯线性磨损值与髋臼外倾角同向相关,其回归方程为y＝4.431-0.21x+0.003x2。
2、生物力学实验：抗杠杆力实验组：各组抗杠杆力分别为无钢珠0。交角组915.04±197.49N、0°交角组449.02±119.78N、10。交角组814.68±53.89N、20。交角组1033.05±226.44N、标准锁定组626.68±206.12N,各组样本的总体方差齐性一致,单因素方差分析显示F为8.989,P<0.001,提示各组间抗杠杆力存在差异。20。交角组、10。交角组、无钢珠0。交角组抗杠杆力均大于标准锁定组。LSD法以标准锁定组为对照组比较与其他各组的差异,发现标准锁定组与20。交角组(P=0.001)、无钢珠0。交角组之间(P=0.016)的比较有统计学差异,P值均小于0.05。与10。交角组比较,P＝0.102,无统计学差异。与标准锁定组比较,0。交角组的抗杠杆力较弱,P值为0.121,两组间没有统计学差异。抗扭转力实验组：各组最大扭矩分别为：无钢珠0。交角组6.39±1.03Nm,0。交角组7.60±1.73Nm、10。交角组7.01±2.25Nm、20。交角组7.32±1.56Nm、标准锁定组23.82±3.78Nm。Levene检验各组样本的总体方差不齐,单因素方差分析显示F=50.859,P<0.001,提示各组间抗扭力扭矩存在差异。采用Gamse-Howell法比较两两组间差异,显示标准锁定组与其他各组比较有统计学差异,P值均等于0.001,其余各组间两两比较没有差异。标准锁定装置显示了较强的抗扭转性能。“纹理化”聚乙烯内衬组：纹理化组：31.03±1.58Nm,标准锁定组23.82±3.78Nm,采用独立样本t检验比较两组均值,两组间方差不齐,F=6.277,P=0.037,独立样本t检验显示t=-3.94,P=0.01,差异有统计学意义。
3、2个采用骨水泥聚乙烯内衬技术更换内衬的全髋关节翻修病例,其髋关节Harris评分分别由术前的53分、66分提高到随访时的97分、97.5分,手术效果满意,无并发症。骨盆及髋关节照片未见髋臼松动及新骨溶解区,植骨生长良好。
结论
1、Harris评分表可制作成临床问卷调查,作为全髋关节置换术后临床随访工作的有益补充。人工全髋关节置换术后髋臼外倾角角度过大有一定的发生率,髋臼外倾角过大是聚乙烯内衬磨损的重要因素之一,初次手术中需要采取有效措施防止髋臼假体外倾角过大。由于髋臼前倾角没有统计,结合髋臼假体外倾角过大的发生率,金属髋臼假体位置不良的发生率不能低估,对其中金属髋臼稳定者行更换聚乙烯内衬翻修,并将聚乙烯内衬以骨水泥固定于正常位置是否可行及可靠,需要进一步研究。
2、生物力学实验：抗杠杆力实验组：与标准锁定装置相比,聚乙烯内衬与金属髋臼之间存在交角时用骨水泥固定,能够提供足够的早期固定强度。抗扭转力实验组：与标准锁定装置相比,聚乙烯内衬与金属髋臼之间以骨水泥固定强度减弱,这与研究采用的聚乙烯内衬外表面光滑、没有纹理化有关,需要对聚乙烯内衬外表面做“纹理化”提高其抗扭转性能。聚乙烯内衬外表面简单的“纹理化”处理加强了聚乙烯-骨水泥界面的抗扭转能力,结果优于标准锁定装置的固定强度。本研究中对聚乙烯内衬外表面纹理化的简单处理可作为研制新型聚乙烯内衬的参考。
3、骨水泥聚乙烯内衬技术上是可行的,手术效果显著,手术操作有其特点,相对于全髋臼翻修创伤小,恢复快,可保留宿主髋臼骨量,延缓全髋臼翻修,是髋臼翻修术中一个可选择的术式。
主要创新点
提出骨水泥内衬改向技术理念,应用于金属髋臼稳定、位置不良时的内衬改向翻修,并对内衬改向翻修的固定强度进行生物力学研究,目前尚未见报道。
Background
Total hip arthroplasty (THA) has been used, successfully and effectively, for the treatment of various advanced stage hip diseases, such as osteoarthritis, rheumatoid arthritis, congenital acetabular dysplasia, avascular necrosis of the femoral head for decades. Harris firstly reported a modular prosthesis in1971, which promoted the development of various materials and the interface combination, and provided surgeons more choices, but also brought wearing, separation, loosen of prosthesis and other complications. Over the past20years, most of THA were composed of metal or ceramic head and traditional polyethylenes (PE) liner. The worn liner, periprothetic osteolysis and prosthesis aseptic loosening resulted from PE particles, were the main reasons of revision.
There are mainly two kinds of techniques in acetabular prosthesis revision, total acetabular revision and isolated acetabular liner exchange. Total acetabular revision with bone grafting if necessary, become a consensus in management of acetabular loosening. For the stable metal acetabular cup with worn liner and various degree of periprothetic osteolysis, the choice of total acetabular revision or liner exchange remains controversial. Lots of surgeons prefer to liner exchange, for which have the advantage of mimic invasive, less bleeding, time and cost effective, bone reservation, eliminating wearing particles and membrane at the same time. Osteolysis can be treated by allograft bone grafting through acetabular screw holes or by fenestration. Liner exchange can avoid acetabular bone defect and pelvic discontinuity, reduce operation disability and mortality rate.
Liner exchange can be divided into simple liner exchange and cemented liner technique. The later which is so-called double-socket technique means a liner was fixed into the original metal acetabular cup with cement. Simple liner exchange is often difficult to carry out because of a damaged locking mechanism (by wear, fatigue or trauma), lack of a replacement liner in desire material or size, and so on. While cement liner technique that fixed a new liner into the original metal acetabular cup with cement, can not only avoid the problems above, but also prevent revision from infection by using antibiotics cement. Cement liner technique can change prosthesis interface to metal liner or other material. Liner with different sizes can be chosen to cement in the original acetabular cup, concerning about the diameter of the femur head and the thickness of liner.
Cemented liner technique in clinical was firstly reported by Heck and Murray in1986and then spreaded worldwide in extensive research and clinical application. Biomechanical studies suggested that the interface fixation of liner-cement-metal acetabular cup was stronger than or comparable to the acetabular standard locking mechanism. Meanwhile, cemented liner technique had also achieved excellent results in clinical or radiographic follow up. The replacement liner, especially the highly cross-linked polyethylene liner could prevent patient from progress or recurrence of osteolysis because of low wear rate and reduce wear particles generated from polyethylene-on-ceramic or polyethylene-on-metal interface. Combined with allograft bone grafting through screw holes or by fenestration in osteolysis area to remove the interface membranes, wear particles and granulation tissue, eliminate osteolysis and recover the bone mass of host acetabulum, cemented liner technique can also promote bone ingrowing with the porous surface of acetabular cup. Although cemented liner technique achieved excellent results, its complications could not be ignored. The rates of hip dislocation after revision were high (range,15%-30%) for several reasons. This technique was limited to the direction of previous acetabular cup. Cemented liner in the acetabular cup of retroversion or excessive abduction made the hip in high risk of dislocation and interface separation. Some authors believed that there were some correlation between dislocation after revision and operative approach. The posterior approach debridement of scar and resection of joint capsule might lead to dislocation, while there was an extremely low rate of hip dislocation in liner revision using lateral or anterior approach.
The proper choice of indication is critical for operation. Cemented liner technique is mainly for the management of the stable acetabular cup with liner wear, damage of locking machanism, lack of liner to match the original acetabular cup. Sometimes, the indications were relative. The healing strategy were adjusted accordingly, such as the local osteolysis need liner revision combined with allograft bone grafting in the osteolysis zone, while extensive or periprosthetic osteolysis should be considered the total acetabular revision. If the acetabular cup had been used for a long time which approach to the prosthesis longevity, the total acetabular revision may be a proper choice, otherwise, cementing a liner will be a good selection. If a patient has a history of dislocation or a mal-positional acetabular cup in his artificial hip joint, liner replacement should be careful for the high risk of dislocation. Most of surgeons prefered to choose total acetabular revision in this condition.
Malposition of artificial acetabulums, such as neutral or backward place, excessive abduction of the metal acetabular cups, is a common defection. Excessive abduction result from seeking osseous containment for getting a satisfactory fixation of acetabular cup, increase liner wear at upper parts. For such cases, whether it is feasible and reliable that a new liner cemented and rolling in an unsatisfied acetabular cup till to a correct abduction or anteversion angle is not reported in our knowledge but a practical topic.
Therefore, we focus our attention on this topic to provide whether cemented liner technique is suitable for such cases for avoiding total acetabular revision preserving bone mass and preventing patient from dislocation.
Objective
1. To compare hip Harris score between surgeon's result and patients' self-evaluation. To access the correlation between abduction angle of acetabular cup and the liner wear, investigate the incidence rate of excessive abduction acetabular cup (≥50°,≥55°), and illustrate the necessity of cemented liner technique in the stable but dys-directional acetabular cup.
2. To evaluate the strength of liner-cement-metal cup interface in cemented liner technique, and assess whether the interface fixation of liner-cement-metal cup is more strength than or equivalent to the acetabular standard locking mechanism when there is a cross angle between metal cup and polyethylene liner. Simply textured at outer surface of the polyethylene liner to strengthen interface stability, and estimate the reinforce effect of the polyethylene-cemented interface. To evaluate the effect of cementing a polyethylene liner in the center of acetabular cup.
3. To investigate the technical key points, feasibility and observe the early clinical effect of the technique that cementing a polyethylene liner into acetabular cup in hip revision.
Methods
1. Clinical investigation:32cases out of147patients(165hip) who were underwent THA in the First Affiliated Hospital of GuanZhou Medical College from January,1993to May,2006, have been performed Harris score by doctors and patients themselves, and the mean of which were compared by using pair-samples T test. Clinical retrospective analysis was performed in147patients (47male,80female) with a mean age60.2years (range,23-85years) who were underwent THA in the First Affiliated Hospital of GuanZhou Medical College before May2011. The anteroposterior films of pelvic were obtained by digital radiography in post-operation and follow-up to measure the abduction angle of acetabular cup by orthopedist and radiologist. Two groups of results were compared, and the incidence of excessive abduction angle greater than50°and55°were also calculated. Meanwhile, the linear polyethylene wear were measured on unilateral THA to access the correlation between abduction angle of acetabular cup and liner wear. Furthermore, the linear wear value of the polyethylene liner were compared between groups of abduction angle<50°and≥50degree, groups of using period less than5years and exceed5years.
2. Biomechanical study:The lever-out test:25pair metal acetabular cups with polyethylene liners were randomly divided into5groups. One group with standard locking mechanism as control group, other liners were cemented into acetubular cups as experimental groups. According to the different intersection angle of metal acetabular cups with polyethylene liners and the polyethylene liners with/without metal ball, the four experimental groups were:no ball0degree group which is metal acetabular cups intersected with polyethylene liners(without metal ball) at0degree angle,0degree group which is metal acetabular cups intersected with polyethylene liners(with metal ball) at0degree angle,10degrees group which is metal acetabular cups intersected with polyethylene liners(with metal ball) at10degree angle,20degrees group which is metal acetabular cups intersected with polyethylene liners(with metal ball) at20degree angle. In order to obtain an even thickness of cement mantle, four balls of2mm diameter were placed between metal cup and polyethylene liner when liners were cemented. The lever-out biomechanical test was then performed at each group to evaluate the lever-out failure strength of liner-cement-metal cup interface. The torsion test:other25pairs metal acetabular cups with polyethylene liners were also randomly divided into5group. One group with standard locking mechanism group as control group, the others were prepared to imitate cementd liner technique as experimental groups. According to the different intersection angle of metal acetabular cups with polyethylene liners and the polyethylene liners with or without metal ball, four experimental groups were:non-ball0degree group stood for metal acetabular cups intersected with polyethylene liners(without metal ball) at0degree angle,0degree group stood for metal acetabular cups intersected with polyethylene liners(with metal ball) at0degree angle,10degrees group which is short for metal acetabular cups intersected with polyethylene liners(with metal ball) at10degree angle,20degrees group stood for metal acetabular cups intersected with polyethylene liners(with metal ball) at20degree angle. In order to obtain a uniform thickness of cemented shell, four balls of2mm in diameter were placed between metal cup and polyethylene liner while fixate liner with cement. The torsion test was also performed at each group to determine the anti-torsion strength of the liner-cement-metal cup interface. Texture reinforce test:10holes were made at the outer surface of5polyethylene liner (2symmetrical holes for each liner) by drill of3mm in depth. Therefore the polyethylene liner was interlocked with cement mantle after cement filled into the hole. Then the ant-torsion strength of the textured liner-cement-metal cup interface were tested and evaluated by comparing with the ant-torsion strength of the standard locking mechanism group.
3. Cementing polyethylene liner into acetabular cup was performed in hip revision in two cases, and a short-term follow-up was carried out to get clinical and imaging findings.
Results
1. The clinical investigation results:In the final follow up, the mean Harris score evaluated by doctors was90.01±7.75points (range,68.5～100points), while take out the score of physical sign and action range, the mean Harris score was83.39+7.591points (range,62～91points) evaluated by doctors VS84.36+6.974points (range,66～91points) evaluated by patients themselves. No significant difference was found between the two groups(t=-0.1567, P=0.126). The mean acetabular abduction angle was47.56°±8.826°measured by joint surgeon VS48.41°±9.395°measured by radiologist, there was statistical difference (t=2.978, P=0.003). Out of145THA, there were32acetabular metal cups with an abduction angle greater than55degrees (15.3%～28.9%), and61acetabular metal cups with an abduction angle greater than50degrees (34.1%～50.1%). The mean of linear wear of polyethylene liner in107patients with unilateral THA was0.832±0.7069mm.A scatter diagram was made to reveal the relationship between abduction angle and liner wear in107unilateral THA, and then a curve estimation was taken by SPSS13.0. R square was up to0.697using Quadratic curve. Regression equation was y=4.431-0.21x+0.003x2.
2. The results of lever-out test:loading on the same moment arm, the mean±sem liver-out failure force were respectively:non-ball0degree group,915.04±197.49N;0degree group,449.02±119.78N;10degrees group,814.68±53.89N; and20degrees group,1033.05±226.44N; while the standard locking group,626.68+206.12N. ANOVA showed significant difference between each mean lever-out force(F=8.989, P<0.001). The lever-out failure forces of20degrees group,10degrees group, non-ball0degree group, were greater than the standard locking group. Using LSD method, the standard locking control group as a control group were compared with each group, the standard locking control group VS20degrees group (P=0.001), VS non-ball0degree group(P=0.016), the mean lever-out failure force of20degrees group and no ball0degree group were significantly greater than the the standard locking control group(P<0.05); while the the standard locking control group VS10degrees group (P=0.102), VS0degree group(P=0.121), the lever-out failure forces were no statistically significant difference between the two groups. The results of torsion test:the mean±sem torsion failure torque were respectively:non-ball0degree group,6.39±1.03Nm;0degree group,7.60±1.73Nm;10degree group,7.01+2.25Nm;20degree group,7.32±1.56Nm; the standard locking group,23.82±3.78Nm. ANOVA showed significant difference between each mean torsion torque(F=50.859, P<0.001). Using Games-Howell method, the standard locking control group were compared with each group, the mean torsion failure torque of the standard locking control group were significantly greater than every experimental group (P=0.001), but no statistically significant difference was found between any two of the experimental groups. Texture reinforce results:the mean torsion torque were:the textured liner group,31.03±1.58Nm; the standard locking control group,23.82±3.78Nm. Using independent sampler T-test, the mean torsion torque were compared between two groups, and the mean torsion torque of the textured liner group was significant greater than the standard locking control group(t=-3.94, P=0.01).
3. The Harris score of two cases were improved respectively from53,66before operation to97,97.5at final follow up, the operative result was satisfactory, no complication was find, the allograft bone was replaced well by new bone, meanwhile, no acetabular cup loosening and new osteolysis area were detected in the radiograms of pelvis and hip joint.
Conclusion
1. Harris score can be used as a clinical questionnaire, it was a helpful supplementary for clinical follow-up. The incidence rate of excessive abduction acetabular cup were relatively high in THA, the excessive abduction angle of acetabular cup was positively correlative to linear wear of polyethylene liner,and the excessive abduction of acetabular cup should be avoided in primary THA for which was relative to wear of polyethylene liner. The incidence rate of metal acetabular cup with should not be ignored due to the high rate of excessive abduction acetabular prosthesis, if the retroversion of acetabular prosthesis which was not measured in the study was take into consideration, the incidence rate of malposition metal acetabular cup will be increased. The feasibility and reliability of the technique that cemented polyethylene liner with correct direction into a stable but improper orientation metal acetabular cup were still need a further study.
2. Comparing to standard locking mechanism, cementing a liner into a metal cup has similar resist strength to lever-out force, but less resist strength to torsion result from the sooth outer surface of polyethylene liner without texture, therefore, interface reinforcement by texture at the outer surface of polyethylene liner were need to improve the resist strength to torsion. The management of simple texture at the outer surface of the polyethylene liner can increase ant-torsion strength of the liner-cement interface, the interface fixation strength were also slightly better than the standard locking mechanism. The simple texture way at the outer surface of the polyethylene liner used in the study can be consulted to the design of new polyethylene liner.
3. Bone cement polyethylene liner technique is feasible, effective and simple. Comparing to total acetabular revision, it is less trauma, recoverying quickly, retaining more bone mass of acetabulum, delaying the total acetabular revision acetabular revision surgery, so it is an alternative technique for acetabular revision.
The main innovative points
The technical concept of cemented liner direction-adjusting was firstly proposed to cement a new liner in a correct direction into a stable but unsatisfied-directional metal acetabular cup, the interface strength were firstly evaluated in biomechanical test. In our knowledge, these are not reported in literature.
引文
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[1]Meldrum RD, Hollis JM. The strength of a cement acetabular locking mechanism. J Arthroplasty 2001;16:748.
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[7]Blom AW, Astle L, Loveridge J,et al. Revision of an acetabular liner has a high risk of dislocation. J Bone Joint Surg Br 87;1636-1638,2005.
[8]Talmo CT, Kwon YM, Freiberg AA, et al. Management of polyethylene wear associated with a well-fixed modular cementless shell during revision total hip arthroplasty. J Arthroplasty.2011;26(4):576-81.
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[12]Restrepo C, Ghanem E, Houssock C, et al. Isolated polyethylene exchange versus acetabular revision for polyethylene wear. Clin Orthop Relat Res. 2009;467:194-198.
[13]O'Brien JJ, Stephen R, Burnett J, et al. Isolated liner exchange in revision total hip arthroplasty. Clinical results using the direct lateral surgical approach. J Arthroplasty.2004; 19-4:414-423.
[14]Koh KH, Moon YW, Lim SJ, et al. Complete acetabular cup revision versus isolated liner exchange for polyethylene wear and osteolysis without loosening in cementless total hip arthroplasty. Arch Orthop Trauma Surg. 2011; 131:1591-600.
[15]康鹏德,裴福兴,沈彬,等.病灶清除植骨保留髋臼假体的翻修术治疗假体周围局灶性骨溶解.中华骨科杂志.2010；10(30)：955-960.
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[18]Haft GF, Heiner AD, Dorr LD, et al. A biomechanical analysis of polyethylene liner cementation into a fixed metal acetabular shell. J Bone Joint Surg Am 2003;85-A:1100.
[19]Dunlop D, Oxland T, Gordon J, et al. The biomechanics of cementing a new liner into a well-fixed metal acetabular shell. Trans Orthop Res 2002;27:973.
[20]Hofmann AA, Prince EJ, Drake FT, et al. Cementation of a polyethylene liner into a metal acetabular shell:a biomechanical study. J Arthroplasty.2009; 24: 775-82.
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[24]Hofmann AA, Prince EJ, Drake FT, et al. Cementation of a polyethylene liner into a metal acetabular shell:a biomechanical study. J Arthroplasty.2009; 24: 775-82.
[25]Terefenko KM, Sychterz CJ, Orishimo K, et al. Polyethylene liner exchange for excessive wear and osteolysis. J Arthroplasty.2002; 17:798-804.
[26]Delanois RE, Seyler TM, Essner A, et al. Cementation of a polyethylene liner into a metal shell. J Arthroplasty.2007; 22:732-7.
[27]Lie SA, Hallan G, Furnes O, et al. Isolated acetabular liner exchange compared with complete acetabular component revision in revision of primary uncemented acetabular components:a study of 1649 revisions from the Norwegian Arthroplasty Register. J Bone Joint Surg Br.2007; 89:591-4.
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[29]Yoon TR, Seon JK, Song EK, et al. Cementation of a metal-inlay polyethylene liner into a stable metal shell in revision total hip arthroplasty. J Arthroplasty.2005; 20:652-7
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[2]Lombardi AV, Berend KR. Isolated Acetabular Liner ExchangeJ Am Acad Orthop Surg. 2008;16:243-248.
[3]Zhang H, Cheng JQ, Shen B, et al. Cementless total hip arthroplasty in Chinese patients with osteonecrosis of the femoral head. J Arthroplasty,2008,23(1):102-111.
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[11]Meehan J, Jamali AA, Nguyen H. Prophylactic Antibiotics in Hip and Knee Arthroplasty. J Bone Joint Surg Am.2009;91:2480-2490.
[12]齐海,丁悦,许杰,等Harris评分和X线在评价全髋关节置换术后疗效中的作用.中华关节外科杂志：电子版.2009；3(4)：444-448.
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[14]卢伟杰,廖威明,余楠生,等.人工全髋关节翻修骨缺损的治疗.中国骨与关节损伤杂志.2005；20-5：299-301.
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