Clinical Survey of Different Abutment Topologies

February 20, 2018 updated by: Oticon Medical

C49:Clinical Survey of Different Abutment Topologies Installed With a Minimally Invasive Surgery for Bone Anchored Hearing Systems

This study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 76
        • Department of Otorhinolaryngology, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Any adult (18 years of age or older) patient eligible for a bone anchored hearing system

Exclusion Criteria:

  • Inability or unwillingness to participate in follow-up
  • Skin thickness of > 10 mm
  • Diseases known to compromise bone quality
  • Irradiated in the implant area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Oticon Medical Machined Abutment
A non surface modified abutment is used
Device: Bone anchored hearing aid
Other Names:
  • BAHS
  • BAHA
Experimental: Oticon Medical Modified Abutment
A surface modified abutment is used
Device: Bone anchored hearing aid
Other Names:
  • BAHS
  • BAHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of colony forming units (CFU)
Time Frame: 3 months post-surgery
The primary end point is CFU counts 3 months post-surgery.
3 months post-surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of colony forming units (CFU) on abutment (CFU/abutment)
Time Frame: 3 months post-surgery
3 months post-surgery
Number of colony forming units (CFU) on abutment (CFU/abutment)
Time Frame: 12 months post-surgery
12 months post-surgery
Number of colony forming units (CFU), strip (CFU/strip)
Time Frame: 3 months post-surgery
3 months post-surgery
Number of colony forming units (CFU), strip (CFU/strip)
Time Frame: 12 months post-surgery
12 months post-surgery
Number of colony forming units (CFU) in tissue samples (CFU/mg
Time Frame: 3 months post-surgery
3 months post-surgery
Number of colony forming units (CFU) in tissue samples (CFU/mg
Time Frame: 12 months post-surgery
12 months post-surgery
RNA level for host inflammatory response
Time Frame: 3 months post-surgery
3 months post-surgery
RNA level for tissue repair
Time Frame: 3 months post-surgery
3 months post-surgery
RNA level for host host microbial infection response
Time Frame: 3 months post-surgery
3 months post-surgery
RNA level for host inflammatory response
Time Frame: 12 months post-surgery
12 months post-surgery
RNA level for tissue repair
Time Frame: 12 months post-surgery
12 months post-surgery
RNA level for host host microbial infection response
Time Frame: 12 months post-surgery
12 months post-surgery
Histology investigation of tissue biopsy
Time Frame: 3 months post-surgery
3 months post-surgery
Histology investigation of tissue biopsy
Time Frame: 12 months post-surgery
12 months post-surgery

Other Outcome Measures

Outcome Measure
Time Frame
Skin status according to Holgers and clinical assessment
Time Frame: 3 months post surgery
3 months post surgery
Skin status according to Holgers and clinical assessment
Time Frame: Up to 24 months post surgery
Up to 24 months post surgery
Postoperative complications
Time Frame: 3 months post surgery
3 months post surgery
Pain and numbness
Time Frame: Up to 24 months post surgery
Up to 24 months post surgery
Implant stability by clinical assessment and implant stability quotient (ISQ)measurements
Time Frame: Up to 24 months post surgery
Up to 24 months post surgery
Pocket depth
Time Frame: 6 months post surgery
6 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oticon Medical

Investigators

  • Study Chair: Sofia Jonhede, Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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