Mayor David, Patel Savan, Perry Clayton, Walter Norman, Burton Stephen, Atkinson Theresa
McLaren Regional Medical Center 401 S. Ballenger Hwy, Flint, MI 48532.
Kettering University 1700 University Ave, Flint, MI 48504.
Iowa Orthop J. 2014;34:78-83.
Early ceramic bearing systems in total hip arthoplasty (THA) sought to provide long term wear improvement over traditional metal on polyethylene systems. However, previous designs exhibited fractures of the ceramic acetabular liner, leading to the development of the Implex Hedrocel ceramic bearing THA system where the ceramic liner was supported on a layer of polyethylene intended to transition liner loads to the metal shell, a so-called "sandwich" design. Unfortunately, the device trial was stopped to further enrollment when liner fractures were reported. The current study examines nearly 10-year follow-up on 28 devices implanted by two surgeons at one institution in order to document ceramic bearing system performance over a longer time period.
Radiographic and patient reported outcomes, in the form of Harris Hip Scores (HHS) and 12-Item Short Form Health Survey (sF-12), were collected.
During the study period two cups were replaced, one at three years and a second at seven years. At the five year follow-up HHS were similar to those reported in the literature for devices with traditional metal-on-polyethylene bearing surfaces and for other sandwich ceramic bearing designs. At the nine year follow-up, the HHS had not changed significantly and SF-12 scores measuring overall physical and mental health were higher than age matched national norms (p<0.001). There were no signs of cup migration, stem subsidence, osteolysis or cup loosening at any time up to the last follow-up in this patient cohort. The 89% survivorship rate and device revisions due to delamination of the liner observed in this group were similar to those reported earlier for this device and for other "sandwich design" ceramic bearing systems.
This cohort did not exhibit new failure modes and HHS and SF-12 scores indicated high functionality for the majority of patients. These data suggest that a focus on preventing ceramic liner fracture through design and/or materials improvements may result in a device with long-term functionality.
全髋关节置换术(THA)中早期的陶瓷轴承系统旨在比传统的金属对聚乙烯系统提供更持久的耐磨性。然而,先前的设计出现了陶瓷髋臼衬垫骨折的情况,这促使了Implex Hedrocel陶瓷轴承THA系统的开发,该系统中陶瓷衬垫由一层聚乙烯支撑,旨在将衬垫负荷转移到金属外壳上,即所谓的“三明治”设计。不幸的是,当报告出现衬垫骨折时,该设备试验停止进一步入组。本研究对一家机构的两位外科医生植入的28个设备进行了近10年的随访,以记录陶瓷轴承系统在更长时间段内的性能。
收集了以Harris髋关节评分(HHS)和12项简短健康调查(sF - 12)形式呈现的影像学和患者报告的结果。
在研究期间,更换了两个髋臼杯,一个在三年时更换,另一个在七年时更换。在五年随访时,HHS与文献中报道的具有传统金属对聚乙烯轴承表面的设备以及其他三明治陶瓷轴承设计的设备相似。在九年随访时,HHS没有显著变化,测量总体身心健康的SF - 12评分高于年龄匹配的全国标准(p < 0.001)。在该患者队列的最后一次随访之前的任何时候,都没有髋臼杯移位、柄下沉、骨溶解或髋臼杯松动的迹象。该组观察到的89%的生存率以及因衬垫分层导致的设备翻修率与该设备以及其他“三明治设计”陶瓷轴承系统早期报告的相似。
该队列未出现新的失效模式,HHS和SF - 12评分表明大多数患者具有高功能。这些数据表明,通过设计和/或材料改进来专注于预防陶瓷衬垫骨折可能会产生具有长期功能的设备。