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

Tim G. A. Calon*, Martin L. Johansson, Arthur J. G. de Bruijn, Herbert van den Berge, Mariet Wagenaar, Edwin Eichhorn, Miranda M. L. Janssen, Janny R. Hof, Jan-Wouter Brunings, Manuela A. Joore, Sofia Jonhede, Joost van Tongeren, Marcus Holmberg, Robert-Jan Stokroos

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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 inflammation (Holgers Index 2) during 12 weeks' follow-up after surgery. Secondary objectives: skin dehiscence, pain scores, loss of sensibility around the implant, soft-tissue overgrowth, skin sagging, implant extrusion, cosmetic results, surgical time, wound healing and Implant Stability Quotient measurements.Results:Sixty-three subjects were analyzed in the intention-to-treat population. No significant difference was found for the incidence of inflammation between groups. Loss of skin sensibility, cosmetic outcomes, skin sagging, and surgical time were significantly better in the test group. No statistically significant differences were found for dehiscence, pain, and soft-tissue overgrowth. A nonsignificant difference in extrusion was found for the test group. The Implant Stability Quotient was statistically influenced by the surgical technique, abutment length, and time.Conclusion:No significant differences between the MIPS and the linear incision techniques were observed regarding skin inflammation. MIPS results in a statistically significant reduction in the loss of skin sensibility, less skin sagging, improved cosmetic results, and reduced surgical time. Although nonsignificant, the implant extrusion rate warrants further research.

Original languageEnglish
Pages (from-to)882-893
Number of pages12
JournalOtology & Neurotology
Volume39
Issue number7
DOIs
Publication statusPublished - Aug 2018

Keywords

  • BAHS
  • Bone conduction
  • Bone-anchored hearing
  • Hearing loss
  • Holgers index
  • Minimally invasive ponto surgery
  • MIPS
  • Soft tissue reactions
  • Surgical outcomes
  • Surgical technique
  • Tissue preservation
  • OSSEOINTEGRATED IMPLANTS
  • SURGICAL TECHNIQUE
  • COST-EFFECTIVENESS
  • COMPLICATIONS
  • STABILITY
  • SURVIVAL
  • AID
  • REHABILITATION
  • TOLERABILITY
  • DEVICE

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