MedPath

Clinical Survey of Different Abutment Topologies

Not Applicable
Completed
Conditions
Unilateral Partial Deafness
Conductive Hearing Loss
Mixed Hearing Loss
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

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
Primary Outcome Measures
NameTimeMethod
Number of colony forming units (CFU)3 months post-surgery

The primary end point is CFU counts 3 months post-surgery.

Secondary Outcome Measures
NameTimeMethod
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/mg12 months post-surgery
RNA level for host inflammatory response12 months post-surgery
RNA level for tissue repair12 months post-surgery
RNA level for host host microbial infection response12 months post-surgery
Histology investigation of tissue biopsy12 months post-surgery

Trial Locations

Locations (1)

Department of Otorhinolaryngology, Karolinska University Hospital

🇸🇪

Stockholm, Sweden

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

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