Livingston B J, Chmell M J, Spector M, Poss R
Brigham and Women's Hospital, Boston, Massachusetts 02115, USA.
J Bone Joint Surg Am. 1997 Oct;79(10):1529-38. doi: 10.2106/00004623-199710000-00010.
We observed early failure and radiographic signs of accelerated wear as early as one to three years after insertion, without cement, of a metal-backed acetabular component with a liner made of Hylamer (DePuy). This finding prompted us to review a larger cohort of patients in whom that liner had been used. Two hundred and thirty-three components with a Hylamer liner, evaluated at a minimum of two years, had a mean rate of wear of 0.27 millimeter per year compared with 0.12 millimeter per year for a contemporaneous group of fifty acetabular cups with a conventional ultra-high molecular weight polyethylene liner made by another manufacturer. At a mean of 3.2 years, we found a significant difference (p < 0.000000006) between the mean rate of wear (0.20 millimeter per year) when the Hylamer liner articulated with a DePuy modular cobalt-chromium femoral head and the mean rate (0.29 millimeter per year) when the liner articulated with an Osteonics modular cobalt-chromium femoral head. Radiographic evaluation revealed a significant correlation between the total linear wear and the prevalence of osteolytic lesions (r2 = 0.76, linear regression analysis). We found that wear of 1.5 millimeters or more could be detected by the unaided eye. Because of the positive correlation between osteolysis and wear of 1.5 millimeters or more, we defined a hip with a liner that had that amount of wear as a hip at risk. We concluded that the wear characteristics of a Hylamer liner in vivo are inferior to those of a conventional ultra-high molecular weight polyethylene liner. Also, the rate of wear of the liner is greater when the femoral head is from a manufacturer other than DePuy. A patient who has a total hip replacement that includes a Hylamer liner should be monitored frequently for signs of wear and osteolytic changes. Additional investigations, with longer durations of follow-up and larger populations, are needed to understand fully the importance of our findings.
我们观察到，在植入无骨水泥的、带有Hylamer（迪普伊公司）内衬的金属背衬髋臼组件后，早在一到三年就出现了早期失效以及加速磨损的影像学迹象。这一发现促使我们对更多使用该内衬的患者群体进行回顾性研究。对233个带有Hylamer内衬且至少经过两年评估的组件进行研究发现，其平均每年磨损率为0.27毫米，而同期一组由另一家制造商生产的、带有传统超高分子量聚乙烯内衬的50个髋臼杯的平均每年磨损率为0.12毫米。平均在3.2年时，我们发现当Hylamer内衬与迪普伊模块化钴铬合金股骨头相匹配时的平均磨损率（每年0.20毫米）与该内衬与奥施康尼模块化钴铬合金股骨头相匹配时的平均磨损率（每年0.29毫米）之间存在显著差异（p < 0.000000006）。影像学评估显示，总线性磨损与溶骨病变的发生率之间存在显著相关性（r2 = 0.76，线性回归分析）。我们发现，肉眼即可检测到1.5毫米或以上的磨损。由于溶骨与1.5毫米或以上磨损之间存在正相关关系，我们将内衬磨损达到该程度的髋关节定义为有风险的髋关节。我们得出结论，Hylamer内衬在体内的磨损特性不如传统超高分子量聚乙烯内衬。此外，当股骨头来自迪普伊公司以外的制造商时，内衬的磨损率更高。接受全髋关节置换且使用Hylamer内衬的患者应经常接受监测，以观察磨损和溶骨变化的迹象。需要进行更长随访时间和更大样本量的进一步研究，以充分了解我们研究结果的重要性。
