目的:本研究报告了十年磨损率,骨质溶解的发生率,临床结果,一项多中心随机对照试验比较了全髋关节置换术(THA)中氧化锆(OxZr)和钴铬(CoCr)股骨头与超高分子量聚乙烯(UHMWPE)和高度交联聚乙烯(XLPE)衬垫的并发症。
方法:从四个机构招募接受原发性THA的患者,并前瞻性地分配到以下治疗组:A组,带XLPE衬垫的CoCr股骨头;B组,带交联聚乙烯衬垫的OxZr股骨头;和C组,带UHMWPE衬垫的OxZr股骨头。所有记录结果的研究患者和评估者对治疗组不知情。对262名研究患者的结果进行了10年的随访分析。
结果:与A组患者相比,C组患者的平均衬垫磨损率增加(0.133mm/yr(SD0.21)对0.031mm/yr(SD0.07),分别为;p<0.001)和B组(0.133毫米/年(SD0.21)vs0.022毫米/年(SD0.05),分别为;p<0.001)在十年的随访中。C组患者还与骨溶解和无菌性松动的风险增加相关,需要进行翻修手术。与A组患者(分别为7/133vs0/133;p=0.007)和B组患者(分别为7/133vs0/135;p=0.007)进行比较。与B组相比,A组的平均衬垫磨损率增加的趋势无统计学意义(0.031mm/yr(SD0.07)vs0.022mm/yr(SD0.05),分别为;p=0.128)。所有三组在术前和十年随访时都具有统计学上的可比性,在测量标准化的西安大略省和麦克马斯特大学骨关节炎指数时(p=0.410),36项简短形式的健康调查(p=0.465心理,p=0.713物理),和疼痛量表评分(p=0.451)。
结论:与XLPE相比,使用UHMWPE与THA后的年衬垫磨损率逐渐增加有关。在十年的随访中,与XLPE相比,接受UHMWPE的组显示需要进行翻修手术的骨溶解和无菌性松动的发生率增加.与CoCr相比,由OxZr组成的股骨头具有降低磨损率的趋势,但这没有达到统计学意义,也没有转化为骨质溶解的任何差异,功能结果,或在两个股骨头组件之间进行翻修手术。引用本文:骨关节J2022;104-B(7):833-843。
OBJECTIVE: This study reports the ten-year wear rates, incidence of osteolysis, clinical outcomes, and complications of a multicentre randomized controlled trial comparing oxidized zirconium (OxZr) versus cobalt-chrome (CoCr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) and highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA).
METHODS: Patients undergoing primary THA were recruited from four institutions and prospectively allocated to the following treatment groups: Group A, CoCr femoral head with XLPE liner; Group B, OxZr femoral head with XLPE liner; and Group C, OxZr femoral head with UHMWPE liner. All study patients and assessors recording outcomes were blinded to the treatment groups. The outcomes of 262 study patients were analyzed at ten years\' follow-up.
RESULTS: Patients in Group C were associated with increased mean liner wear rates compared to patients in Group A (0.133 mm/yr (SD 0.21) vs 0.031 mm/yr (SD 0.07), respectively; p < 0.001) and Group B (0.133 mm/yr (SD 0.21) vs 0.022 mm/yr (SD 0.05), respectively; p < 0.001) at ten years\' follow-up. Patients in Group C were also associated with increased risk of osteolysis and aseptic loosening requiring revision surgery, compared with patients in Group A (7/133 vs 0/133, respectively; p = 0.007) and Group B (7/133 vs 0/135, respectively; p = 0.007). There was a non-statistically significant trend towards increased mean liner wear rates in Group A compared with Group B (0.031 mm/yr (SD 0.07) vs 0.022 mm/yr (SD 0.05), respectively; p = 0.128). All three groups were statistically comparable preoperatively and at ten years\' follow-up when measuring normalized Western Ontario and McMaster Universities Osteoarthritis Index (p = 0.410), 36-Item Short Form Health Survey (p = 0.465 mental, p = 0.713 physical), and pain scale scores (p = 0.451).
CONCLUSIONS: The use of UHMWPE was associated with progressively increased annual liner wear rates after THA compared to XLPE. At ten years\' follow-up, the group receiving UHMWPE demonstrated an increased incidence of osteolysis and aseptic loosening requiring revision surgery compared to XLPE. Femoral heads composed of OxZr were associated with trend towards reduced wear rates compared to CoCr, but this did not reach statistical significance and did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two femoral head components. Cite this article: Bone Joint J 2022;104-B(7):833-843.