Higher early proximal migration of hemispherical cups with electrochemically applied hydroxyapatite (BoneMaster) on a porous surface compared with porous surface alone: a randomized RSA study with 53 patients
Higher early proximal migration of hemispherical cups with electrochemically applied hydroxyapatite (BoneMaster) on a porous surface compared with porous surface alone: a randomized RSA study with 53 patients
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DOI：
10.1080/17453674.2019.1687860
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发表时间：
2019-11-07
影响因子：
3.7
通讯作者：
Stilling, Maiken
中科院分区：
文献类型：
--
作者：
Jorgensen, Peter Bo;Daugaard, Henrik;Stilling, Maiken
背景和目的：BoneMaster(BM)是一种电化学沉积的羟基磷灰石(HA)种植体涂层，分布均匀，厚度薄，吸收快。它旨在促进骨整合和早期种植体的稳定性，并减轻长期的HA诱导的第三体聚乙烯磨损。这项研究评估了使用或不使用BM的无骨水泥多孔涂层半球形杯的早期移位和功能结果。患者和方法：采用随机双盲对照试验，53例髋关节炎患者平均年龄为(55-75岁)，分别采用超杯(ZYMER BIOMET)和双节段支架(ZYMER BIOMET)加多孔和BM涂层(PBM)或仅用多孔涂层(P)进行手术。术后及术后3、6、12、24个月进行随访。用RSA和PROMS测量视杯移位的效果。结果：随访6个月时，PBM组近端视杯移位(0.09 mm，95%CI 0.02~0.20)高于P组(0.25 mm，CI 0.15~0.35)。在1年和2年的随访中，两组间所有6个自由度的眼杯移位情况相似(p>；0.2)。从术前到术后2年随访，牛津髋关节评分(OHS)平均提高17分(CI 14~20)。髋关节残疾和骨关节炎结果评分(HOOS)在所有分项中都有所增加，但在症状分项评分中，PBM组比P组更明显(p=0.04)。解释-与预期相反，PBM杯比P杯有更高的早期迁移。在两年的随访中，两组之间的迁移情况相似。在髋臼杯上涂上BM涂层似乎没有早期的好处。
Background and purpose - BoneMaster (BM) is an electrochemically deposited hydroxyapatite (HA) implant-coating, which is evenly distributed, thin, and quickly resorbed. It is designed to stimulate osseointegration and early implant stability and alleviate longer-term HA-induced third-body polyethylene wear. This study evaluates early cup migration and functional outcomes of cementless porous-coated hemispherical cups with or without BM. Patients and methods - In a patient-blinded, randomized, controlled trial 53 patients at mean 64 years (55-75) with coxarthritis were operated with an Exceed cup (Zimmer Biomet) and Bi-Metric stem (Zimmer Biomet) with porous and BM coating (PBM) or with porous coating alone (P). Follow-ups were performed postoperatively and at 3, 6, 12, and 24 months. Effect measures were cup migration measured with RSA and PROMs. Results - At 6-month follow-up, proximal cup migration in the PBM group (0.09 mm, 95% CI 0.02-0.20) was higher than in the P group (0.25 mm, CI 0.15-0.35). At 1- and 2-year follow-up, cup migration in all 6 degrees of freedom was similar between groups (p > 0.2). From before surgery to 2-year follow-up, Oxford Hip Score (OHS) increased by 17 points (CI 14-20). Hip disability and Osteoarthritis Outcome Score (HOOS) increased in all sub-scores, but was more pronounced for PBM cups compared with P cups in the Symptoms sub-score (p = 0.04). Interpretation - Contrary to expectations, PBM cups had higher early migration than P cups. At 2-year follow-up, migration was similar between groups. There seems to be no early benefit of BM coating on acetabular cups.