Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial.

ABSTRACT:

Objective

To compare the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with those of the linear incision technique with soft-tissue preservation for bone-anchored hearing systems (BAHS).

Design

Sponsor-initiated multicenter, open, randomized, controlled clinical trial.

Setting

Maastricht University Medical Centre, Ziekenhuisgroep Twente and Medisch Centrum Leeuwarden, all situated in The Netherlands.

Participants

Sixty-four adult patients eligible for unilateral BAHS surgery.Interventions Single-stage BAHS surgery with 1:1 randomization to the linear incision technique with soft-tissue preservation (control) or the MIPS (test) group.

Primary and secondary outcome measurements

Primary objective: compare the incidence of inflam

SUBMITTER: Calon TGA 

PROVIDER: S-EPMC6075882 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature