| Autor: |
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 |
| Předmět: |
|
| Zdroj: |
Frontiers in Neurology; 2/24/2021, Vol. 11, pN.PAG-N.PAG, 14p |
| Abstrakt: |
Objective: 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. Methods: 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. Results: 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%). Conclusion: 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. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02438618. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
|
