Aesculap AG Research & Development,Tuttlingen, Germany.
BMC Musculoskelet Disord. 2010 Jan 4;11:3. doi: 10.1186/1471-2474-11-3.
Modular neck adapters for hip arthroplasty stems allow the surgeon to modify CCD angle, offset and femoral anteversion intraoperatively. Fretting or crevice corrosion may lead to failure of such a modular device due to high loads or surface contamination inside the modular coupling. Unfortunately we have experienced such a failure of implants and now report our clinical experience with the failures in order to advance orthopaedic material research and joint replacement surgery.The failed neck adapters were implanted between August 2004 and November 2006 a total of about 5000 devices. After this period, the titanium neck adapters were replaced by adapters out of cobalt-chromium. Until the end of 2008 in total 1.4% (n = 68) of the implanted titanium alloy neck adapters failed with an average time of 2.0 years (0.7 to 4.0 years) postoperatively. All, but one, patients were male, their average age being 57.4 years (36 to 75 years) and the average weight 102.3 kg (75 to 130 kg). The failures of neck adapters were divided into 66% with small CCD of 130 degrees and 60% with head lengths of L or larger. Assuming an average time to failure of 2.8 years, the cumulative failure rate was calculated with 2.4%.
A series of adapter failures of titanium alloy modular neck adapters in combination with a titanium alloy modular short hip stem was investigated. For patients having received this particular implant combination risk factors were identified which were associated with the occurRence of implant failure. A Kaplan-Meier survival-failure-analysis was conducted. The retrieved implants were analysed using microscopic and chemical methods. Modes of failure were simulated in biomechanical tests. Comparative tests included modular neck adapters made of titanium alloy and cobalt chrome alloy material.
Retrieval examinations and biomechanical simulation revealed that primary micromotions initiated fretting within the modular tapered neck connection. A continuous abrasion and repassivation process with a subsequent cold welding at the titanium alloy modular interface. Surface layers of 10 - 30 microm titanium oxide were observed. Surface cracks caused by fretting or fretting corrosion finally lead to fatigue fracture of the titanium alloy modular neck adapters. Neck adapters made of cobalt chrome alloy show significantly reduced micromotions especially in case of contaminated cone connection. With a cobalt-chromium neck the micromotions can be reduced by a factor of 3 compared to the titanium neck. The incidence of fretting corrosion was also substantially lower with the cobalt-chromium neck configuration.
Failure of modular titanium alloy neck adapters can be initiated by surface micromotions due to surface contamination or highly loaded implant components. In the present study, the patients at risk were men with an average weight over 100 kg. Modular cobalt chrome neck adapters provide higher safety compared to titanium alloy material.
髋关节置换术的模块化颈接头允许外科医生在术中修改 CCD 角度、偏移量和股骨前倾角。由于高负荷或模块化连接内部的表面污染,微动或缝隙腐蚀可能导致这种模块化装置失效。不幸的是,我们已经遇到了这种植入物的失效,并报告了我们在失效方面的临床经验,以便推进骨科材料研究和关节置换手术。失效的颈接头于 2004 年 8 月至 2006 年 11 月共植入约 5000 个装置。在此期间,钛合金颈接头被钴铬合金接头取代。到 2008 年底,共有 1.4%(n=68)植入的钛合金颈接头失效,平均术后时间为 2.0 年(0.7 至 4.0 年)。所有患者(除 1 例外)均为男性,平均年龄 57.4 岁(36 至 75 岁),平均体重 102.3 公斤(75 至 130 公斤)。颈接头的失效分为 66%的小 CCD 为 130 度和 60%的头长为 L 或更大。假设失效的平均时间为 2.8 年,则用 2.4%计算累积失效率。
研究了与钛合金模块化短髋柄组合使用的钛合金模块化颈接头的一系列接头失效。对于接受这种特殊植入物组合的患者,确定了与植入物失效发生相关的风险因素。进行了 Kaplan-Meier 生存失败分析。使用显微镜和化学方法分析了回收的植入物。在生物力学试验中模拟了失效模式。比较试验包括钛合金和钴铬合金材料制成的模块化颈接头。
回收检查和生物力学模拟表明,最初的微动在模块化锥形颈连接内引发微动。钛合金模块化界面处不断的磨损和重新钝化过程,随后发生冷焊。观察到 10-30 微米厚的钛氧化物表面层。微动或微动腐蚀引起的表面裂纹最终导致钛合金模块化颈接头的疲劳断裂。钴铬合金制成的颈接头显示出明显减少的微动,尤其是在污染的锥连接的情况下。与钛合金颈相比,钴铬合金颈可将微动减少 3 倍。钴铬合金颈配置的微动腐蚀发生率也大大降低。
由于表面污染或高负荷植入物部件,表面微动可能导致模块化钛合金颈接头失效。在本研究中,有风险的患者是平均体重超过 100 公斤的男性。与钛合金材料相比,模块化钴铬合金颈接头提供更高的安全性。