Salemyr Mats, Muren Olle, Ahl Torbjörn, Bodén Henrik, Chammout Ghazi, Stark André, Sköldenberg Olof
Division of Orthopaedics, Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
Int Orthop. 2015 Aug;39(8):1499-505. doi: 10.1007/s00264-015-2680-3. Epub 2015 Jan 29.
We hypothesized that a vitamin E-treated polyethylene articulating liner had lower femoral head penetration than a conventional liner.
Fifty-one patients with primary hip osteoarthritis were randomized to an uncemented cup with either vitamin E-treated highly cross-linked polyethylene (HXLPE) (vitamin-e group, n = 25) or a standard HXLPE liner (control group, n = 26) and followed for two years after surgery. The outcome variable was polyethylene (PE) linear head penetration, measured with radiostereometry (RSA).
The head penetration in x- (medial/lateral) and y- (vertical) axes was significantly lower for the vitamin E-treated liner up to two years with a mean difference between the groups of 0.10 mm (95 % CI 0.04-0.18) and 0.08 mm (95 % CI 0.01-0.15), respectively. The initial total penetration was lower for the vitamin-E group but did not reach statistical significance at two years with a mean difference between the groups of 0.07 mm (95 % CI -0.001 to 0.15, p = 0.09). We found no differences in clinical outcome between the groups.
In this prospective, randomized, controlled trial on a new vitamin-E diffused HXLPE liner we found, compared to a conventional HXLPE liner, lower initial head penetration and lower superior and medial wear. A longer follow-up than two years is necessary to demonstrate lower overall head penetration in vitamin-E liners compared to contemporary highly cross-linked PE.
我们推测,经维生素E处理的聚乙烯关节衬垫的股骨头穿透率低于传统衬垫。
51例原发性髋关节骨关节炎患者被随机分为两组,一组使用经维生素E处理的高交联聚乙烯(HXLPE)非骨水泥杯(维生素E组,n = 25),另一组使用标准HXLPE衬垫(对照组,n = 26),术后随访两年。观察指标为通过放射立体测量法(RSA)测量的聚乙烯(PE)线性股骨头穿透率。
在长达两年的时间里,经维生素E处理的衬垫在x轴(内侧/外侧)和y轴(垂直)上的股骨头穿透率显著更低,两组之间的平均差异分别为0.10毫米(95%置信区间0.04 - 0.18)和0.08毫米(95%置信区间0.01 - 0.15)。维生素E组的初始总穿透率较低,但在两年时未达到统计学显著性,两组之间的平均差异为0.07毫米(95%置信区间 - 0.001至0.15,p = 0.09)。我们发现两组之间的临床结果没有差异。
在这项关于新型维生素E扩散HXLPE衬垫的前瞻性、随机、对照试验中,我们发现,与传统HXLPE衬垫相比,新型衬垫的初始股骨头穿透率更低, superior和内侧磨损也更低。与当代高交联聚乙烯相比,需要超过两年的更长随访时间来证明维生素E衬垫的总体股骨头穿透率更低。