Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants (C50)

The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.

Study Overview

• Status: Completed
• Conditions: Conductive Hearing Loss; Unilateral Partial Deafness; Mixed Conductive-sensorineural Hearing Loss
• Intervention / Treatment: Procedure: Surgery for Ponto bone anchored hearing aids

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patient, i.e. ≥ 18 years of age
• Eligible for the Ponto system

Exclusion Criteria:

• Known history of immunosuppressive disease
• Use of systemic immunosuppressive medication
• Receiving bilateral bone anchored hearing system
• Relevant dermatological diseases as judged by the investigator
• Not being able to finish the study, for example because of failure to complete the questionnaires
• Participating in another study with medical aids or medication
• When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Minimally invasive punch technique; New surgical technique for Ponto bone anchored hearing implants	Procedure: Surgery for Ponto bone anchored hearing aids
OTHER: Hultcrantz technique; Standard surgical technique for bone anchored hearing implants	Procedure: Surgery for Ponto bone anchored hearing aids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of inflammation (Holgers index ≥ 2)	3 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))		3 months post surgery
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)		3 months post surgery
Loss of sensibility (Measured in mm outwards from the abutment)		3 months post surgery
Soft tissue overgrowth (mm)		3 months post surgery
Extrusion rate (number of implants lost)		3 months post surgery
Implant stability quotient (ISQ) measurements (ISQ units 1-100)		3 months post surgery
Surgical time (minutes)		3 months post surgery
Wound healing time (time to reach healed)		3 months post surgery
Holgers index ≥ 2 at any time point		24 months post surgery
Presence of dehiscence after surgery (present/not present)		24 months post surgery
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)		24 months post surgery
Loss of sensibility (Measured in mm outwards from the abutment)		24 months post surgery
Soft tissue overgrowth (mm)		24 months post surgery
Extrusion rate (number of implants lost)		24 months post surgery
Implant stability quotient (ISQ) measurements (ISQ units 1-100)	Measured in ISQ units (1-100)	24 months post surgery
Cosmetic result (10 point scale)	Scored using a 10-point scale and are compared to the healthy, normal contralateral situation	24 months post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin position (analysed descriptively using photographs and computer software)	Only at main center	3 months post surgery
Dynamic skin motion (analysed descriptively using photographs and computer software)	Only at main center	3 months post surgery
Quality of life related questionnaires		24 months post surgery
Correlation between cytokines and Holgers index		24 months post surgery
Correlation IS-pro profile and Holgers index		24 months post surgery
Development of a peri-implant dermatitis scale and compare it to the Holgers Index		24 months post surgery

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: Robert Stokroos, Professor, Maastricht University Medical Centre (MUMC+)

Publications and helpful links

General Publications

• Strijbos RM, Straatman LV, Calon TGA, Johansson ML, de Bruijn AJG, van den Berge H, Wagenaar M, Eichhorn E, Janssen M, Jonhede S, van Tongeren J, Holmberg M, Stokroos R. Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices. Front Neurol. 2021 Feb 24;12:632987. doi: 10.3389/fneur.2021.632987. eCollection 2021.
• Calon TG, van Hoof M, van den Berge H, de Bruijn AJ, van Tongeren J, Hof JR, Brunings JW, Jonhede S, Anteunis LJ, Janssen M, Joore MA, Holmberg M, Johansson ML, Stokroos RJ. 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. Trials. 2016 Nov 9;17(1):540. doi: 10.1186/s13063-016-1662-0.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2014
• Primary Completion (ACTUAL): December 20, 2016
• Study Completion (ACTUAL): November 18, 2018

Study Registration Dates

• First Submitted: April 21, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (ESTIMATE): May 8, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Conductive
• Other Study ID Numbers: C50