Clinical Survey of Different Abutment Topologies

Conductive Hearing Loss Clinical Trial

Official title:

C49:Clinical Survey of Different Abutment Topologies Installed With a Minimally Invasive Surgery for Bone Anchored Hearing Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304692
• Other study ID #: C49
• Status: Completed
• Phase: N/A
• First received: November 14, 2014
• Last updated: February 20, 2018
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed Conductive-Sensorineural
• Mixed Hearing Loss
• Unilateral Partial Deafness

Intervention

Device:
• Bone anchored hearing aid

Locations

Country	Name	City	State
Sweden	Department of Otorhinolaryngology, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin status according to Holgers and clinical assessment		3 months post surgery
Other	Skin status according to Holgers and clinical assessment		Up to 24 months post surgery
Other	Postoperative complications		3 months post surgery
Other	Pain and numbness		Up to 24 months post surgery
Other	Implant stability by clinical assessment and implant stability quotient (ISQ)measurements		Up to 24 months post surgery
Other	Pocket depth		6 months post surgery
Primary	Number of colony forming units (CFU)	The primary end point is CFU counts 3 months post-surgery.	3 months post-surgery
Secondary	Number of colony forming units (CFU) on abutment (CFU/abutment)		3 months post-surgery
Secondary	Number of colony forming units (CFU) on abutment (CFU/abutment)		12 months post-surgery
Secondary	Number of colony forming units (CFU), strip (CFU/strip)		3 months post-surgery
Secondary	Number of colony forming units (CFU), strip (CFU/strip)		12 months post-surgery
Secondary	Number of colony forming units (CFU) in tissue samples (CFU/mg		3 months post-surgery
Secondary	Number of colony forming units (CFU) in tissue samples (CFU/mg		12 months post-surgery
Secondary	RNA level for host inflammatory response		3 months post-surgery
Secondary	RNA level for tissue repair		3 months post-surgery
Secondary	RNA level for host host microbial infection response		3 months post-surgery
Secondary	RNA level for host inflammatory response		12 months post-surgery
Secondary	RNA level for tissue repair		12 months post-surgery
Secondary	RNA level for host host microbial infection response		12 months post-surgery
Secondary	Histology investigation of tissue biopsy		3 months post-surgery
Secondary	Histology investigation of tissue biopsy		12 months post-surgery