search
Back to results

Clinical Survey of Different Abutment Topologies

Primary Purpose

Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bone anchored hearing aid
Sponsored by
Oticon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conductive Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Otorhinolaryngology, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Oticon Medical Machined Abutment

Oticon Medical Modified Abutment

Arm Description

A non surface modified abutment is used

A surface modified abutment is used

Outcomes

Primary Outcome Measures

Number of colony forming units (CFU)
The primary end point is CFU counts 3 months post-surgery.

Secondary Outcome Measures

Number of colony forming units (CFU) on abutment (CFU/abutment)
Number of colony forming units (CFU) on abutment (CFU/abutment)
Number of colony forming units (CFU), strip (CFU/strip)
Number of colony forming units (CFU), strip (CFU/strip)
Number of colony forming units (CFU) in tissue samples (CFU/mg
Number of colony forming units (CFU) in tissue samples (CFU/mg
RNA level for host inflammatory response
RNA level for tissue repair
RNA level for host host microbial infection response
RNA level for host inflammatory response
RNA level for tissue repair
RNA level for host host microbial infection response
Histology investigation of tissue biopsy
Histology investigation of tissue biopsy

Full Information

First Posted
November 14, 2014
Last Updated
February 20, 2018
Sponsor
Oticon Medical
search

1. Study Identification

Unique Protocol Identification Number
NCT02304692
Brief Title
Clinical Survey of Different Abutment Topologies
Official Title
C49:Clinical Survey of Different Abutment Topologies Installed With a Minimally Invasive Surgery for Bone Anchored Hearing Systems
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oticon Medical Machined Abutment
Arm Type
Sham Comparator
Arm Description
A non surface modified abutment is used
Arm Title
Oticon Medical Modified Abutment
Arm Type
Experimental
Arm Description
A surface modified abutment is used
Intervention Type
Device
Intervention Name(s)
Bone anchored hearing aid
Other Intervention Name(s)
BAHS, BAHA
Primary Outcome Measure Information:
Title
Number of colony forming units (CFU)
Description
The primary end point is CFU counts 3 months post-surgery.
Time Frame
3 months post-surgery
Secondary Outcome Measure Information:
Title
Number of colony forming units (CFU) on abutment (CFU/abutment)
Time Frame
3 months post-surgery
Title
Number of colony forming units (CFU) on abutment (CFU/abutment)
Time Frame
12 months post-surgery
Title
Number of colony forming units (CFU), strip (CFU/strip)
Time Frame
3 months post-surgery
Title
Number of colony forming units (CFU), strip (CFU/strip)
Time Frame
12 months post-surgery
Title
Number of colony forming units (CFU) in tissue samples (CFU/mg
Time Frame
3 months post-surgery
Title
Number of colony forming units (CFU) in tissue samples (CFU/mg
Time Frame
12 months post-surgery
Title
RNA level for host inflammatory response
Time Frame
3 months post-surgery
Title
RNA level for tissue repair
Time Frame
3 months post-surgery
Title
RNA level for host host microbial infection response
Time Frame
3 months post-surgery
Title
RNA level for host inflammatory response
Time Frame
12 months post-surgery
Title
RNA level for tissue repair
Time Frame
12 months post-surgery
Title
RNA level for host host microbial infection response
Time Frame
12 months post-surgery
Title
Histology investigation of tissue biopsy
Time Frame
3 months post-surgery
Title
Histology investigation of tissue biopsy
Time Frame
12 months post-surgery
Other Pre-specified Outcome Measures:
Title
Skin status according to Holgers and clinical assessment
Time Frame
3 months post surgery
Title
Skin status according to Holgers and clinical assessment
Time Frame
Up to 24 months post surgery
Title
Postoperative complications
Time Frame
3 months post surgery
Title
Pain and numbness
Time Frame
Up to 24 months post surgery
Title
Implant stability by clinical assessment and implant stability quotient (ISQ)measurements
Time Frame
Up to 24 months post surgery
Title
Pocket depth
Time Frame
6 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Jonhede
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Otorhinolaryngology, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Clinical Survey of Different Abutment Topologies

We'll reach out to this number within 24 hrs