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全膝关节置换术中高交联聚乙烯与传统聚乙烯的多中心研究。

Multicenter Study of Highly Cross-linked vs Conventional Polyethylene in Total Knee Arthroplasty.

作者信息

Meneghini R Michael, Ireland Philip H, Bhowmik-Stoker Manoshi

机构信息

Department of Orthopaedic Surgery, Indiana University Health Physicians, Indiana University School of Medicine, Indianapolis, Indiana.

Stryker Orthopaedics, Mahwah, New Jersey.

出版信息

J Arthroplasty. 2016 Apr;31(4):809-14. doi: 10.1016/j.arth.2015.10.034. Epub 2015 Dec 12.

Abstract

BACKGROUND

Despite substantial interest and use of highly cross-linked polyethylene (HXLPE) in total knee arthroplasty (TKA), outcomes remain largely unknown. The purpose of this study is to compare HXLPE and conventional polyethylene at 4- to 5-year follow-up.

METHODS

A prospective multicenter study of 307 posterior-stabilized TKAs (168 conventional and 139 HXLPE) was performed. Short-Form-6D, Short-Form 36, Knee Society Score, Lower Extremity Activity Score, health-related quality of life outcomes, and radiographs were collected preoperatively and at routine postoperative intervals.

RESULTS

Two hundred twenty-four patients obtained a minimum 4- to 5-year follow-up for analysis. There were no osteolysis or polyethylene failures in either group. Although both conventional and HXLPE poly groups showed significant improvements in all measures from preoperative baselines (P < .05), the XLPE group had slightly greater mean Knee Society Score function (P = .04), Lower Extremity Activity Score (P = .03), and Short-Form 36 Physical Composite Score (P = .03) scores and a greater improvement in Short-Form 6D health-related quality of life of 0.16 points (d = 1.02, 95% CI: 0.01-1.11) at latest follow-up.

CONCLUSION

The study findings support comparative safety and outcomes of HXLPE related to mechanical failure or osteolysis in the midterm. However, longer-term follow-up is warranted to assess whether wear and mechanical properties of HXLPE are maintained in vivo.

摘要

背景

尽管高度交联聚乙烯(HXLPE)在全膝关节置换术(TKA)中受到广泛关注并被大量使用,但其结果在很大程度上仍不明确。本研究的目的是比较4至5年随访期内的HXLPE和传统聚乙烯。

方法

对307例后稳定型TKA进行了一项前瞻性多中心研究(168例使用传统聚乙烯,139例使用HXLPE)。术前及术后常规随访时收集简明健康状况调查问卷简表6D(Short-Form-6D)、简明健康状况调查问卷简表36(Short-Form 36)、膝关节协会评分、下肢活动评分、健康相关生活质量结果及X线片。

结果

224例患者获得了至少4至5年的随访用于分析。两组均未出现骨溶解或聚乙烯失败情况。尽管传统聚乙烯组和HXLPE组在所有测量指标上均较术前基线有显著改善(P < 0.05),但HXLPE组在最新随访时的膝关节协会评分功能平均分(P = 0.04)、下肢活动评分(P = 0.03)和简明健康状况调查问卷简表36身体综合评分(P = 0.03)略高,且简明健康状况调查问卷简表6D健康相关生活质量提高了0.16分(d = 1.02,95%CI:0.01 - 1.11)。

结论

研究结果支持HXLPE在中期与机械故障或骨溶解相关的比较安全性和结果。然而,需要进行更长时间的随访以评估HXLPE在体内的磨损和机械性能是否得以维持。

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