Clinical Survey of Different Abutment Topologies

Overview

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.

Full Title of Study: “C49:Clinical Survey of Different Abutment Topologies Installed With a Minimally Invasive Surgery for Bone Anchored Hearing Systems”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2016

Interventions

  • Device: Bone anchored hearing aid

Arms, Groups and Cohorts

  • Sham Comparator: Oticon Medical Machined Abutment
    • A non surface modified abutment is used
  • Experimental: Oticon Medical Modified Abutment
    • A surface modified abutment is used

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oticon Medical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sofia Jonhede, Study Chair, Sponsor GmbH

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