Wazen Jack J, Daugherty Julie, Darley Spencer, Wycherly Benjamin
Silverstein Institute, Ear Research Foundation, Sarasota, Florida.
Silverstein Institute, Ear Research Foundation, Sarasota, Florida.
Am J Otolaryngol. 2015 Mar-Apr;36(2):195-9. doi: 10.1016/j.amjoto.2014.10.030. Epub 2014 Oct 30.
The timing of loading of titanium craniofacial implants is dependent upon implant characteristics, host factors, and the bonding of titanium oxide and bone referred to as osseointegration. The purpose of this feasibility study seeks to determine the safety of early loading of the Baha BI-300 implant system (Cochlear Limited, Englewood, CO), which has been modified with novel surface texture and geometric design.
This prospective study measures implant stability as determined by clinical evaluation and resonance frequency analysis at implantation and at 1, 3, 6, 12, 24 and 52weeks post-op in 20 patients who underwent single-stage implantation and exteriorization of the BI-300. The processor was loaded at 3weeks post-operatively. A modified Holger's classification system was used to evaluate skin reactions.
There was a positive linear trend in mean implant stability scores from implantation to 52weeks. Only one subject (5%) had a mild local soft tissue Holger's grade 1 score at 24weeks. No implant loss or postoperative complications were encountered as a result of the 3-week loading.
Three-week loading of the BI-300 implant did not result in any implant loss or failure of osseointegration. Earlier activation of the external processor with earlier hearing rehabilitation resulted in improved patient satisfaction. Further studies are needed to confirm these results for more universal adoption of early loading in adults.
钛颅面植入物的加载时机取决于植入物特性、宿主因素以及氧化钛与骨的结合,即骨整合。本可行性研究的目的是确定经新型表面纹理和几何设计改良的巴哈BI - 300植入系统(科利耳有限公司,科罗拉多州恩格尔伍德)早期加载的安全性。
本前瞻性研究对20例行BI - 300单阶段植入及外置术的患者,在植入时以及术后1、3、6、12、24和52周,通过临床评估和共振频率分析来测量植入物稳定性。术后3周加载处理器。采用改良的霍尔格分类系统评估皮肤反应。
从植入到52周,平均植入物稳定性评分呈正线性趋势。仅1名受试者(5%)在24周时出现轻度局部软组织霍尔格1级评分。3周加载未导致任何植入物丢失或术后并发症。
BI - 300植入物3周加载未导致任何植入物丢失或骨整合失败。更早启用外部处理器并进行更早的听力康复可提高患者满意度。需要进一步研究以证实这些结果,以便在成人中更广泛地采用早期加载。