NCT02438618

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2018

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

2.1 years

First QC Date

April 21, 2015

Last Update Submit

August 29, 2019

Conditions

Conductive Hearing LossUnilateral Partial DeafnessMixed Conductive-sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Incidence of inflammation (Holgers index ≥ 2)

    3 months post surgery

Secondary Outcomes (16)

  • 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

  • +11 more secondary outcomes

Other Outcomes (6)

  • Skin position (analysed descriptively using photographs and computer software)

    3 months post surgery

  • Dynamic skin motion (analysed descriptively using photographs and computer software)

    3 months post surgery

  • Quality of life related questionnaires

    24 months post surgery

  • +3 more other outcomes

Study Arms (2)

Minimally invasive punch technique

EXPERIMENTAL

New surgical technique for Ponto bone anchored hearing implants

Procedure: Surgery for Ponto bone anchored hearing aids

Hultcrantz technique

OTHER

Standard surgical technique for bone anchored hearing implants

Procedure: Surgery for Ponto bone anchored hearing aids

Interventions

Surgery for Ponto bone anchored hearing aidsPROCEDURE
Hultcrantz techniqueMinimally invasive punch technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (3)

  • Strijbos RM, Straatman LV, Stegeman I, Holmberg M, Johansson ML, Stokroos RJ. Health Economic Cost Analysis for Percutaneous Bone Conduction Devices: The Minimally Invasive Ponto Surgery Versus Linear Incision Technique with Tissue Preservation. Otol Neurotol. 2023 Aug 1;44(7):709-717. doi: 10.1097/MAO.0000000000003939. Epub 2023 Jun 29.

    PMID: 37400140DERIVED

  • 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.

    PMID: 33716934DERIVED

  • 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.

    PMID: 27829464DERIVED

MeSH Terms

Conditions

Hearing Loss, ConductiveHearing Loss, Mixed Conductive-Sensorineural

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Stokroos, Professor

    Maastricht University Medical Centre (MUMC+)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

May 8, 2015

Study Start

December 2, 2014

Primary Completion

December 20, 2016

Study Completion

November 18, 2018

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations

NL(1)