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Completed

NCT Number: NCT02304692

Clinical Survey of Different Abutment Topologies

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.

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Key information

Conditions

Conductive Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural Mixed Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Unilateral Partial Deafness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otorhinolaryngology, Karolinska University Hospital

Stockholm, 171 76, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone anchored hearing aid

Device

Other names: BAHS, BAHA

Primary outcomes

  1. Number of colony forming units (CFU)

    Time frame: 3 months post-surgery

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

Secondary outcomes

  1. Number of colony forming units (CFU) on abutment (CFU/abutment)

    Time frame: 3 months post-surgery

  2. Number of colony forming units (CFU) on abutment (CFU/abutment)

    Time frame: 12 months post-surgery

  3. Number of colony forming units (CFU), strip (CFU/strip)

    Time frame: 3 months post-surgery

  4. Number of colony forming units (CFU), strip (CFU/strip)

    Time frame: 12 months post-surgery

  5. Number of colony forming units (CFU) in tissue samples (CFU/mg

    Time frame: 3 months post-surgery

  6. Number of colony forming units (CFU) in tissue samples (CFU/mg

    Time frame: 12 months post-surgery

  7. RNA level for host inflammatory response

    Time frame: 3 months post-surgery

  8. RNA level for tissue repair

    Time frame: 3 months post-surgery

  9. RNA level for host host microbial infection response

    Time frame: 3 months post-surgery

  10. RNA level for host inflammatory response

    Time frame: 12 months post-surgery

  11. RNA level for tissue repair

    Time frame: 12 months post-surgery

  12. RNA level for host host microbial infection response

    Time frame: 12 months post-surgery

  13. Histology investigation of tissue biopsy

    Time frame: 3 months post-surgery

  14. Histology investigation of tissue biopsy

    Time frame: 12 months post-surgery

Other outcomes

  1. Skin status according to Holgers and clinical assessment

    Time frame: 3 months post surgery

  2. Skin status according to Holgers and clinical assessment

    Time frame: Up to 24 months post surgery

  3. Postoperative complications

    Time frame: 3 months post surgery

  4. Pain and numbness

    Time frame: Up to 24 months post surgery

  5. Implant stability by clinical assessment and implant stability quotient (ISQ)measurements

    Time frame: Up to 24 months post surgery

  6. Pocket depth

    Time frame: 6 months post surgery

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 2, 2014
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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