Strijbos Ruben M, Straatman Louise V, Calon Tim G A, Johansson Martin L, de Bruijn Arthur J G, van den Berge Herbert, Wagenaar Mariette, Eichhorn Edwin, Janssen Miranda, Jonhede Sofia, van Tongeren Joost, Holmberg Marcus, Stokroos Robert
Department of Otorhinolaryngology and Head and Neck Surgery, University Medical Centre Utrecht, Utrecht, Netherlands.
University Medical Centre Utrecht Brain Centre, University of Utrecht, Utrecht, Netherlands.
Front Neurol. 2021 Feb 24;12:632987. doi: 10.3389/fneur.2021.632987. eCollection 2021.
Comparing the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with the linear incision technique with soft tissue preservation (LITT-P) for bone conduction devices after a follow-up of 22 months. In this multicenter randomized controlled trial, there was the inclusion of 64 adult patients eligible for unilateral surgery. There was 1:1 randomization to the MIPS (test) or the LITT-P (control) group. The primary outcome was an (adverse) soft tissue reaction. Secondary outcomes were pain, loss of sensibility, soft tissue height/overgrowth, skin sagging, implant loss, Implant Stability Quotient measurements, cosmetic scores, and quality of life questionnaires. Sixty-three subjects were analyzed in the intention-to-treat population. No differences were found in the presence of (adverse) soft tissue reactions during complete follow-up. Also, there were no differences in pain, wound dehiscence, skin level, soft tissue overgrowth, and overall quality of life. Loss of sensibility (until 3-month post-surgery), cosmetic scores, and skin sagging outcomes were better in the MIPS group. The Implant Stability Quotient was higher after the LITT-P for different abutment lengths at various points of follow-up. Implant extrusion was nonsignificantly higher after the MIPS (15.2%) compared with LITT-P (3.3%). The long-term results show favorable outcomes for both techniques. The MIPS is a promising technique with some benefits over the LITT-P. Concerns regarding nonsignificantly higher implant loss may be overcome with future developments and research. www.ClinicalTrials.gov, identifier: NCT02438618.
在随访22个月后，比较微创桥接手术（MIPS）技术与保留软组织的线性切口技术（LITT-P）用于骨传导装置的手术效果。在这项多中心随机对照试验中，纳入了64例符合单侧手术条件的成年患者。按1:1随机分为MIPS（试验）组或LITT-P（对照）组。主要结局是（不良）软组织反应。次要结局包括疼痛、感觉丧失、软组织高度/过度生长、皮肤松弛、种植体丢失、种植体稳定性商数测量、美容评分和生活质量问卷。在意向性分析人群中对63名受试者进行了分析。在整个随访期间，未发现（不良）软组织反应存在差异。此外，在疼痛、伤口裂开、皮肤水平、软组织过度生长和总体生活质量方面也没有差异。MIPS组在感觉丧失（直到术后3个月）、美容评分和皮肤松弛结局方面表现更好。在不同随访时间点，对于不同基台长度，LITT-P术后的种植体稳定性商数更高。与LITT-P（3.3%）相比，MIPS术后种植体挤出率略高（15.2%），但差异无统计学意义。长期结果显示两种技术都有良好的效果。MIPS是一种有前景的技术，比LITT-P有一些优势。关于种植体丢失略高但无统计学意义的问题，可能会随着未来的发展和研究得到解决。ClinicalTrials.gov网站，标识符：NCT02438618。
