Clinical Evaluation of a Novel Laser-Ablated Titanium Implant System for Bone Anchored Hearing Systems in a Pediatric Population and the Relationship of Resonance Frequency Analysis With Implant Survival.
Clinical Evaluation of a Novel Laser-Ablated Titanium Implant System for Bone Anchored Hearing Systems in a Pediatric Population and the Relationship of Resonance Frequency Analysis With Implant Survival.
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DOI：
10.1097/mao.0000000000003435
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发表时间：
2022-02-01
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影响因子：
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通讯作者：
McDermott AL
中科院分区：
文献类型：
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作者：
Osborne MS;Child-Hymas A;Holmberg M;Thomsen P;Johansson ML;McDermott AL
旨在评估植入新型 4.5mm 宽激光烧蚀钛骨锚固种植体系统的儿科患者的临床结果，并评估前 12 个月内种植体的稳定性。一项前瞻性、单受试者、重复测量、队列研究。参与者充当自己的对照。社区和三级转诊医院儿科评估中心。 2016 年 1 月至 2019 年 1 月，共有 115 名年龄在 4 至 15 岁的儿童患者连续植入了 176 个激光烧蚀钛骨锚固种植体。研究了前 12 个月的临床结果、种植失败率和植入后种植体稳定性商数 (ISQ) 评分。通过混合效应模型对数据进行统计显着性分析，显着性水平p = 0.01。观察到 12 个月的中位生存率为 96.6%。总共丢失了六颗种植体（3.5%），其中一颗（0.6%）因外伤而丢失。在所有术后就诊中，有 4.4% 的人观察到皮肤不良反应（Holgers 2-4 级），其中 22 人 (19.1%) 发生了这种反应。在第一阶段和第二阶段手术之间，ISQ 高 (ISQH) 和 ISQ 低 (ISQL) 值均没有显着增加。相比之下，无论基台尺寸如何，ISQ 结果在 12 个月的审查期间都呈现出从 49.1 到 57 的增长趋势。仅从 3 个月的随访开始，才显示出统计学上显着的变化。与以前的植入系统相比，使用 4.5 毫米宽的激光烧蚀钛骨锚固听力植入体具有更高的存活率和优异的临床结果。
To evaluate the clinical outcomes of pediatric patients implanted a novel 4.5 mm wide laser ablated titanium bone anchored implant system and to evaluate the implant stability over the first 12-month period. A prospective, single-subject, repeated measure, cohort study. Participants served as their own controls. Community and tertiary referral hospital pediatric assessment center. A total of 115 consecutive pediatric patients aged 4 to 15 years were implanted with 176 laser ablated titanium bone anchored implants from January 2016 to January 2019. Clinical outcomes, implant failure rates, and post implantation implant stability quotient (ISQ) scores were studied over the first 12-month period. Data were analyzed for statistical significance through mixed effect modeling, with the significance level p = 0.01. A median 12-month survival of 96.6% was observed. Six implants (3.5%) were lost in total, one of these (0.6%) was lost due to trauma. Adverse skin reactions (Holgers grade 2–4) were observed in 4.4% of all postoperative visits, occurring in 22 individuals (19.1%). Neither the ISQ high (ISQH) nor ISQ low (ISQL) values increased significantly between the stage 1 and 2 surgeries. In contrast, the ISQ results, irrespective of abutment size, demonstrated an increasing trend from 49.1 to 57 over the 12 months review period. A statistically significant change was only demonstrated from the 3 months follow up onwards. The use of 4.5 mm wide laser-ablated titanium bone anchored hearing implants resulted in superior survival rates and excellent clinical outcomes compared with previous implant systems.