NCT02064478

Brief Summary

A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness. With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study. The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

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

February 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

February 14, 2014

Last Update Submit

February 20, 2018

Conditions

Conductive Hearing LossMixed Hearing LossSingle Sided Deafness

Keywords

Bone anchored hearing implantBone anchored hearing device

Outcome Measures

Primary Outcomes (1)

  • Numbness around implant, specifically mean Total sensibility

    36 months after surgery

Secondary Outcomes (48)

  • Length of surgery

    At surgery

  • Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient

    0-6 months

  • Mild/Adverse skin reaction

    0-6 months

  • Skin condition according to Holgers

    7 days after surgery

  • Postoperative complications

    7 days to 6 months

  • +43 more secondary outcomes

Other Outcomes (7)

  • Skin height around abutment (in mm)

    At surgery

  • Skin height around abutment (in mm)

    7 days post surgery

  • Skin height around abutment (in mm)

    21 days post surgery

  • +4 more other outcomes

Study Arms (2)

Tissue preservation

Ponto implant installed using a tissue preservation surgical technique

Tissue reduction

Ponto implant installed using a classical technique with skin thinning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients to be included are already planned for treatment with a bone anchored hearing aid at Radboud University Nijmegen Medical Centre (Nijmegen, The Netherlands).

You may qualify if:

  • years or older
  • Patient indicated for an ear level bone anchored sound processor
  • Bone thickness at the implant site of at least 4 mm

You may not qualify if:

  • Inability to participate in follow-up
  • Psychiatric disease in the medical history
  • Mental disability
  • Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
  • Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
  • Patients with natural skin height of \>10 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • den Besten CA, Bosman AJ, Nelissen RC, Mylanus EA, Hol MK. Controlled Clinical Trial on Bone-anchored Hearing Implants and a Surgical Technique With Soft-tissue Preservation. Otol Neurotol. 2016 Jun;37(5):504-12. doi: 10.1097/MAO.0000000000000994.

    PMID: 26945315BACKGROUND

MeSH Terms

Conditions

Hearing Loss, ConductiveHearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

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

Study Officials

  • Myrthe KS Hol, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Emmanuel AM Mylanus, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 17, 2014

Study Start

February 1, 2014

Primary Completion

April 1, 2015

Study Completion

September 1, 2017

Last Updated

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)