10 年随访时压配杯聚 Sterilization 对磨损、骨溶解和生存率的影响。
The effect of poly sterilization on wear, osteolysis and survivorship of a press-fit cup at 10-year followup.
机构信息
Anderson Orthopaedic Research Institute, PO Box 7088, Alexandria, VA 22307, USA.
出版信息
Clin Orthop Relat Res. 2012 Feb;470(2):462-70. doi: 10.1007/s11999-011-2052-2.
BACKGROUND
During the mid-1990s when our institution was using a press-fit porous-coated cup without supplemental initial fixation for primary THA, the manufacturer transitioned from gamma irradiation to gas plasma for the terminal sterilization of their polyethylene liners.
QUESTIONS/PURPOSES: At minimum 10-year followup, we asked whether the fixation achieved by solely relying on a press-fit would be durable and how different liner sterilization methods affected radiographic wear, osteolysis, and survivorship.
PATIENTS AND METHODS
We retrospectively reviewed 373 patients who underwent 398 primary THAs with a press-fit porous-coated cup between March 1995 and December 1996. Mean age at time of surgery was 61.5 ± 13.3 years and mean followup was 10.4 ± 3.7 years. We determined reasons for revision, survivorship, femoral head penetration, osteolysis, and wear-related complications.
RESULTS
Among 20 revisions involving any component, seven were associated with wear and osteolysis. Kaplan-Meier survivorship, using component revision for any reason as an end point, was 95.7% (95% confidence interval, 93.6%-97.9%) at 10 years. Noncrosslinked liners sterilized with gas plasma demonstrated a mean head penetration rate of 0.20 ± 0.09 mm/year compared with 0.13 ± 0.07 mm/year for liners sterilized with gamma irradiation in air and 0.09 ± 0.04 mm/year for liners sterilized with gamma-irradiation with barrier packaging without oxygen. THAs with increased volumetric wear tended to demonstrate larger osteolytic lesions (r = 0.40) and there tended to be less osteolysis among the liners sterilized with gamma-irradiation with barrier packaging without oxygen. However, there was no difference in survivorship among the sterilization groups and there has been no cup or stem loosening associated with osteolysis.
CONCLUSIONS
Durable biologic fixation through 10-year followup can be achieved by solely relying on an initial press-fit. Noncrosslinking gas plasma for terminal sterilization of the polyethylene liners was associated with greater head penetration rate than gamma irradiation.
LEVEL OF EVIDENCE
Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
背景
在 20 世纪 90 年代中期，当我们的机构在初次全髋关节置换术中使用压配式多孔涂层杯且不额外进行初始固定时，制造商将聚乙烯衬垫的最终灭菌方式从伽马射线辐照改为气体等离子体。
问题/目的：在至少 10 年的随访中，我们询问仅依靠压配是否能实现持久固定，以及不同的衬垫灭菌方法如何影响射线照相磨损、骨溶解和存活率。
患者和方法
我们回顾性分析了 1995 年 3 月至 1996 年 12 月期间 373 例接受压配式多孔涂层杯初次全髋关节置换术的患者，共 398 髋。手术时的平均年龄为 61.5±13.3 岁，平均随访时间为 10.4±3.7 年。我们确定了翻修的原因、存活率、股骨头穿透、骨溶解和与磨损相关的并发症。
结果
在 20 次涉及任何部件的翻修中，有 7 次与磨损和骨溶解有关。以任何原因的部件翻修为终点，Kaplan-Meier 存活率在 10 年时为 95.7%（95%置信区间，93.6%-97.9%）。用气体等离子体灭菌的非交联衬垫的平均头穿透率为 0.20±0.09mm/年，而用空气的伽马射线辐照灭菌的衬垫为 0.13±0.07mm/年，用伽马射线辐照并采用无氧屏障包装的衬垫为 0.09±0.04mm/年。容积磨损较大的髋关节往往表现出更大的溶骨病变（r=0.40），而用伽马射线辐照并采用无氧屏障包装的衬垫的骨溶解程度较小。然而，各组的存活率没有差异，也没有与骨溶解相关的杯或柄松动。
结论
通过 10 年的随访，可以仅依靠初始压配实现持久的生物学固定。与伽马射线辐照相比，非交联气体等离子体用于聚乙烯衬垫的最终灭菌与更高的头穿透率相关。
证据水平
IV 级，治疗研究。有关证据水平的完整描述，请参见作者指南。
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