Clinical trial NCT02304692: 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
Overall status: COMPLETED
Phase: NA
Conditions: Conductive Hearing Loss
Unilateral Partial Deafness
Mixed Hearing Loss
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of colony forming units (CFU)
timeFrame: 3 months post-surgery
Secondary outcomes:
measure: Number of colony forming units (CFU) on abutment (CFU/abutment)
timeFrame: 3 months post-surgery
measure: Number of colony forming units (CFU) on abutment (CFU/abutment)
timeFrame: 12 months post-surgery
measure: Number of colony forming units (CFU), strip (CFU/strip)
timeFrame: 3 months post-surgery
measure: Number of colony forming units (CFU), strip (CFU/strip)
timeFrame: 12 months post-surgery
measure: Number of colony forming units (CFU) in tissue samples (CFU/mg
timeFrame: 3 months post-surgery
measure: Number of colony forming units (CFU) in tissue samples (CFU/mg
timeFrame: 12 months post-surgery
measure: RNA level for host inflammatory response
timeFrame: 3 months post-surgery
measure: RNA level for tissue repair
timeFrame: 3 months post-surgery
measure: RNA level for host host microbial infection response
timeFrame: 3 months post-surgery
measure: RNA level for host inflammatory response
timeFrame: 12 months post-surgery
measure: RNA level for tissue repair
timeFrame: 12 months post-surgery
measure: RNA level for host host microbial infection response
timeFrame: 12 months post-surgery
measure: Histology investigation of tissue biopsy
timeFrame: 3 months post-surgery
measure: Histology investigation of tissue biopsy
timeFrame: 12 months post-surgery
Other outcomes:
measure: Skin status according to Holgers and clinical assessment
timeFrame: 3 months post surgery
measure: Skin status according to Holgers and clinical assessment
timeFrame: Up to 24 months post surgery
measure: Postoperative complications
timeFrame: 3 months post surgery
measure: Pain and numbness
timeFrame: Up to 24 months post surgery
measure: Implant stability by clinical assessment and implant stability quotient (ISQ)measurements
timeFrame: Up to 24 months post surgery
measure: Pocket depth
timeFrame: 6 months post surgery
Locations:
city: Stockholm
country: Sweden
facility: Department of Otorhinolaryngology, Karolinska University Hospital
Study officials:
affiliation: Sponsor GmbH
name: Sofia Jonhede
role: STUDY_CHAIR
References: