Clinical Survey of Different Abutment Topologies
C49:Clinical Survey of Different Abutment Topologies Installed With a Minimally Invasive Surgery for Bone Anchored Hearing Systems
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 14, 2014
CompletedFirst Posted
Study publicly available on registry
December 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 22, 2018
February 1, 2018
1.4 years
November 14, 2014
February 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of colony forming units (CFU)
The primary end point is CFU counts 3 months post-surgery.
3 months post-surgery
Secondary Outcomes (14)
Number of colony forming units (CFU) on abutment (CFU/abutment)
3 months post-surgery
Number of colony forming units (CFU) on abutment (CFU/abutment)
12 months post-surgery
Number of colony forming units (CFU), strip (CFU/strip)
3 months post-surgery
Number of colony forming units (CFU), strip (CFU/strip)
12 months post-surgery
Number of colony forming units (CFU) in tissue samples (CFU/mg
3 months post-surgery
- +9 more secondary outcomes
Other Outcomes (6)
Skin status according to Holgers and clinical assessment
3 months post surgery
Skin status according to Holgers and clinical assessment
Up to 24 months post surgery
Postoperative complications
3 months post surgery
- +3 more other outcomes
Study Arms (2)
Oticon Medical Machined Abutment
SHAM COMPARATORA non surface modified abutment is used
Oticon Medical Modified Abutment
EXPERIMENTALA surface modified abutment is used
Interventions
Eligibility Criteria
You may qualify if:
- Any adult (18 years of age or older) patient eligible for a bone anchored hearing system
You may not qualify if:
- Inability or unwillingness to participate in follow-up
- Skin thickness of \> 10 mm
- Diseases known to compromise bone quality
- Irradiated in the implant area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oticon Medicallead
Study Sites (1)
Department of Otorhinolaryngology, Karolinska University Hospital
Stockholm, 171 76, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sofia Jonhede
Sponsor GmbH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2014
First Posted
December 2, 2014
Study Start
October 1, 2014
Primary Completion
March 1, 2016
Study Completion
December 1, 2017
Last Updated
February 22, 2018
Record last verified: 2018-02