Clinical Survey of Different Abutment Topologies

Not Applicable

Completed

• Conditions: Unilateral Partial Deafness; Conductive Hearing Loss; Mixed Hearing Loss
• Interventions: Device: Bone anchored hearing aid

• Registration Number: NCT02304692
• Lead Sponsor: Oticon Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-12-02
• Primary Completion: 2016-03
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oticon Medical Modified Abutment	Bone anchored hearing aid	A surface modified abutment is used
Oticon Medical Machined Abutment	Bone anchored hearing aid	A non surface modified abutment is used

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of colony forming units (CFU) on abutment (CFU/abutment)	12 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	12 months post-surgery
RNA level for host inflammatory response	12 months post-surgery
RNA level for tissue repair	12 months post-surgery
RNA level for host host microbial infection response	12 months post-surgery
Histology investigation of tissue biopsy	12 months post-surgery

Trial Locations

Locations (1)

Department of Otorhinolaryngology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden