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Zweymüller非骨水泥型全髋关节置换术后5-10年随访研究
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摘要
研究背景
     虽然Zweym(u|")ller非骨水泥型人工全髋关节假体(BICON—PLUS双锥面螺旋臼和SL-PLUS矩形股骨柄)在设计理念、材料及表明处理等方面较之前同类假体有明显改善,但螺旋臼及矩形股骨柄的疗效一直饱受争议,有学者认为其与半球形臼及圆柱形或椭圆形股骨柄相比易出现假体松动等问题。目前国内外骨科医生对于假体类型的选择方面仍存在分歧。此外,由于国人在身体特点及生活习惯等方面与西方国家存在一定差异,采用螺旋臼及矩形股骨柄的全髋关节置换术的中远期效果是否与国外报道一致需进一步研究。因此,本课题对1996-2002年在南方医院由同一术者行初次全髋关节置换术且应用Zweym(u|")ller型人工髋关节假体的患者进行了5-10年的随访,从而系统评估BICON—PLUSH双锥面螺旋臼和SL—PLUS股骨柄的中期疗效,并为国内外骨科医生选择假体提供临床参考依据。
     目的
     评估BICON—PLUS双锥面螺旋臼和SL—PLUS股骨柄术后5-10年的疗效,为骨科医生选择假体提供参考依据。
     方法
     1、随访方法
     采取门诊随访、电话随访和上门随访相结合的方式。首先通过电话或信件联系患者来我院门诊随访;对于能够取得联系但距离较远的患者通过电话随访,并嘱其按要求在当地医院拍X线片并将片寄回:对于未留有联系电话、信件寄出后长期未与随访人员取得联系的患者或因某些原因不愿来门诊随访的患者采用上门随访的方式,由随访人员陪同到当地医院行X线检查。
     2、评估方法包括临床评估和放射学评估两部分。临床评估指标包括:Harris评分、术后疼痛时间、术后扶拐行走时间、满意度、并发症等。放射学评估指标包括:异位骨化、骨皮质肥厚、髓内骨化、透亮带、骨溶解、磨损率等。所有数据的采集及评估均由独立检查者完成。磨损数据采用X线片进行测量,并根据已知的股骨头直径(28mm)校正。
     结果
     1、共116例142髋符合纳入标准,57例72髋获得随访,随访率为49.1%。44例57髋同时获临床及放射学评估,7例8髋只获得临床评估,6例7髋只获得放射学评估。57例患者中,男31例41髋,女26例31髋;双髋15例,单髋42例;左髋33个,右髋39个。随访时间为平均7.4年(5-10年)。手术时平均年龄为51.1岁,平均体重指数22.7。手术原因:股骨头无菌性坏死44例55髋,强直性脊柱炎7例10髋,先天性髋臼发育不良继发骨性关节炎2例3髋,原发性骨性关节炎2例2髋,股骨颈骨折术后骨不连2例2髋。
     2、Harris评分由术前的平均46.0分提高到随访时的平均93.2分,49髋(75.4%)术后疼痛在1个月内缓解,术后弃拐行走时间平均为2个月。X线随访见远端骨皮质肥厚26髋(44.1.%),髓内骨化26髋(49.1%),异位骨化40髋(62.5%)。无一例髋臼侧出现透亮带,23髋(35.9%)股骨侧可见透亮带,均为区域性透亮带,以1区发生率最高。7髋(10.9%)髋臼侧出现骨溶解,18髋(28.1%)股骨侧出现骨溶解,骨溶解发生率为32.8%:髋臼侧骨溶解以3区发生率最高,而股骨侧则以7区发生率最高。聚乙烯磨损率为0.09mm/年(陶瓷—聚乙烯)和0.12mm/年(金属—聚乙烯)。虽然无已行翻修病例,但2髋因髋臼松动移位需行翻修术。以翻修手术或需行翻修手术作为失败的标准,髋臼杯假体存活率为96.9%,股骨柄的存活率为100%。
     结论
     1、Harris评分由术前的平均46.0分提高到随访时的平均93.2分;远端骨皮质肥厚发生率为44.1%,髓内骨化发生率为49.1%,异位骨化发生率为62.5%,透亮带发生率为35.9%,骨溶解发生率为32.8%;髋臼杯假体存活率为96.9%,股骨柄的存活率为100%。
     2、本组病例假体存活率与近似随访年限的其他文献报道相当,但骨溶解发生率偏高。总体疗效令人满意。
     3、116例142髋中57例72髋获得随访,随访率为49.1%。更换联系方式或记载不详、患者防病治病意识薄弱是造成随访率偏低的主要原因。
Backgrounds
     The value of threaded uncemented cups and rectangular stems is still controversial because some anthors consider that this kind of prosthesis is prone to loosening compared with hemispheric cups and cylindrical or elliptic stems,though a significant improvement have been caused on design,material and surface roughness of Zweym(u|")ller hip system comprising a threaded double-cone cup and a rectangular stem.Besides,due to the differences in living habit and body conditions,whether the intermediate-term or even long-term results associated with the use of Zweym(u|")ller hip system in China is comparable with previous literatures in developed countries is still unknown.This program was conducted to review the cases who were treated with total hip replacement from 1996 to 2002 by a single surgeon using cementless Zweym(u|")ller hip systems in Nanfang Hospital and to provide references for orthopedists for prosthesis selection.
     Objectives
     To analyze the intermediate-term results associated with the use of Zweym(u|")ller hip system and to provide references for orthopedists for prosthesis selection.
     Methods
     1.Follow-up methods
     Patients who could be contacted through telephone or letters were suggested to visit the out-patient clinic for an evaluation.Patients who were unable to return for a follow-up evaluation due to a long distance from our hospital completed a telephone interview and sent recent radiograghs.With regard to the patients who had a clear address but could not be contacted through telephone or letters, investigator dropped in and took radiograghs at their local hospitals.
     2.Evaluation methods
     Both clinical evaluation and radiological evaluation were performed.Harris hip score,pain extinction time,crutch walking time,functional capabilities,patient satisfaction and complications were the clinical items involved while the radiological items included cortical hypertrophy,medullary sclerosis,heterotopic ossification,radiolucent lines,osteolysis and wear rate.Data collection and evaluation was accomplished by an independent investigator.Linear wear was measured on radiograghs and was corrected for magnification by comparing the diameter of the femoral head on each individual radiogragh with the known diameter of 28 mm.
     Results
     1.116 cases(142 hips) were involved,of which 57 cases(72 hips) were available for following up.44 cases(57 hips) were evaluated both clinically and radiographically while 7 cases(8 hips) and 6 cases(7 hips) were only evaluated clinically and radiographically respectively.Unilateral arthroplasty had been performed in 42 cases,whereas 15 cases had bilateral arthroplasty.The average follow-up period was 7.4 years(range 5 to 10 years).The average age at the initial operation was 51.1 and the average body mass index was 22.7.Initial diagnosis:aseptic necrosis of femoral head(44 cases,55 hips),ankylosing spondylitis(7 cases,10 hips),congenital dysplasia of the hip(2 cases,3 hips), idiopathic osteoarthritis(2 cases,2 hips),nonunion after femoral neck fracture(2 cases,2 hips).
     2.The mean preoperative Harris hip score(HHS) was 46.0 while the mean postoperative HHS was 93.2.Distal cortical hypertrophy and medullary sclerosis were observed in 26 hips(44.1%) and 26 hips(49.1%) respectively.Heterotopic ossification arose in 40 hips(62.5%).Radiolucent lines occured in 23 stems(35.9%) but in no cups.Radiolucent lines were mostly observed in Gruen zone 1.Osteolysis oecured in 7 cups(10.9%) and 18 stems(28.1%).Osteolysis was mostly observed in Delee Zone 3 and Gruen zone 7.In the distal Gruen zones 3,4 and 5,no radiolucent line or osteolysis was observed.Mean linear polyethylene wear rate was 0.09mm/y and 0.12mm/y for ceramic-polyethylene prosthesis and metal-polyethylene prosthesis respectively.No hips had been revised,two cups needed revision surgery because of aseptic loosening.The survivorship with aseptic loosening as a definition of failure was 96.9%for the acetabular component and 100%for the femoral component.
     Conclusions
     1.The mean preoperative HHS was 46.0 while the mean postoperative HHS was 93.2.The incidence rate of cortical hypertrophy,medullary sclerosis,heterotopic ossification,radiolucent lines and osteolysis was 44.1%,49.1%,62.5%,35.9%and 32.8%respectively.The survivorship was 96.9%for the acetabular component and 100%for the femoral component.
     2.The survival rate of Zweym(u|")ller hip systems in this group was comparable with previous literatures with approximate follow-up period,but osteolysis was more common.The overall results were satisfactory.
     3.Of the 116 cases,57 cases were followed up and the follow-up ratio was 49.1%.The reasons for a low follow-up ratio included contact messages not detailed enough or changed and patients'ignorance.
引文
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