Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial.
Over the last years, less invasive surgical techniques with soft tissue preservation for bone conduction hearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results using this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin sensibility. Recently, a new standardized surgical technique for BCHI placement, the Minimally Invasive Ponto Surgery (MIPS) technique has been developed by Oticon Medical AB (Askim, Sweden). This technique aims to standardize surgery by using a novel surgical instrumentation kit and minimize soft tissue trauma.



A multicenter randomized controlled trial is designed to compare the MIPS technique to the linear incision technique with soft tissue preservation. The primary investigation center is Maastricht University Medical Center. Sixty-two participants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of skin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of sampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs and skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine expression. The primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of the skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the abutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation.



This is the first trial to compare the recently developed MIPS technique to the linear incision technique with soft tissue preservation for BCHI surgery. Newly introduced parameters and sampling method will aid in the prediction of results and complications after BCHI placement.



Registered at the CCMO register in the Netherlands on 24 November 2014: NL50072.068.14 . Retrospectively registered on 21 April 2015 at ClinicalTrials.gov: NCT02438618 . This trial is sponsored by Oticon Medical AB.
Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. tim.calon@mumc.nl.
Tim G A
0000-0002-6844-1692
TG
Calon
Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Marc
M
van Hoof
Department of Otorhinolaryngology, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands.
Herbert
H
van den Berge
Department of Otorhinolaryngology, ZiekenhuisGroep Twente, Almelo, The Netherlands.
Arthur J G
AJ
de Bruijn
Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Joost
J
van Tongeren
Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Janny R
JR
Hof
Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Jan Wouter
JW
Brunings
Oticon Medical AB, Askim, Sweden.
Sofia
S
Jonhede
Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Lucien J C
LJ
Anteunis
Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.|Department of Methodology and Statistics, School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands.
Miranda
M
Janssen
Department of Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht University Medical Centre, Maastricht, The Netherlands.
Manuela A
MA
Joore
Oticon Medical AB, Askim, Sweden.
Marcus
M
Holmberg
Oticon Medical AB, Askim, Sweden.|Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Martin L
ML
Johansson
Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Robert J
RJ
Stokroos
D001844:Bone Conduction; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003872:Dermatitis / Q000209:etiology; D004867:Equipment Design; D017048:Health Care Costs; D006310:Hearing Aids / Q000191:economics; D034381:Hearing Loss / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000601:surgery*; D006801:Humans; D009426:Netherlands; D013506:Otologic Surgical Procedures / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation; D017060:Patient Satisfaction; D019986:Persons with Hearing Disabilities / Q000523:psychology / Q000534:rehabilitation*; D012107:Research Design; D012307:Risk Factors; D013529:Surgical Wound Dehiscence; D053441:Suture Anchors; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing
BAHA; Bone conduction device (BCD); Bone conduction hearing implant (BCHI); MIPS; Randomized Controlled Trial (RCT); Soft tissue preservation