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Completed

NCT Number: NCT02438618

Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants

The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.

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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 Conductive-sensorineural 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

Maastricht University Medical Centre

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient, i.e. ≥ 18 years of age
  • Eligible for the Ponto system

Exclusion criteria

  • Known history of immunosuppressive disease
  • Use of systemic immunosuppressive medication
  • Receiving bilateral bone anchored hearing system
  • Relevant dermatological diseases as judged by the investigator
  • Not being able to finish the study, for example because of failure to complete the questionnaires
  • Participating in another study with medical aids or medication
  • When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.

Treatment and study plan

Surgery for Ponto bone anchored hearing aids

Procedure

Primary outcomes

  1. Incidence of inflammation (Holgers index ≥ 2)

    Time frame: 3 months post surgery

Secondary outcomes

  1. Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))

    Time frame: 3 months post surgery

  2. Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)

    Time frame: 3 months post surgery

  3. Loss of sensibility (Measured in mm outwards from the abutment)

    Time frame: 3 months post surgery

  4. Soft tissue overgrowth (mm)

    Time frame: 3 months post surgery

  5. Extrusion rate (number of implants lost)

    Time frame: 3 months post surgery

  6. Implant stability quotient (ISQ) measurements (ISQ units 1-100)

    Time frame: 3 months post surgery

  7. Surgical time (minutes)

    Time frame: 3 months post surgery

  8. Wound healing time (time to reach healed)

    Time frame: 3 months post surgery

  9. Holgers index ≥ 2 at any time point

    Time frame: 24 months post surgery

  10. Presence of dehiscence after surgery (present/not present)

    Time frame: 24 months post surgery

  11. Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)

    Time frame: 24 months post surgery

  12. Loss of sensibility (Measured in mm outwards from the abutment)

    Time frame: 24 months post surgery

  13. Soft tissue overgrowth (mm)

    Time frame: 24 months post surgery

  14. Extrusion rate (number of implants lost)

    Time frame: 24 months post surgery

  15. Implant stability quotient (ISQ) measurements (ISQ units 1-100)

    Time frame: 24 months post surgery

    Measured in ISQ units (1-100)

  16. Cosmetic result (10 point scale)

    Time frame: 24 months post surgery

    Scored using a 10-point scale and are compared to the healthy, normal contralateral situation

Other outcomes

  1. Skin position (analysed descriptively using photographs and computer software)

    Time frame: 3 months post surgery

    Only at main center

  2. Dynamic skin motion (analysed descriptively using photographs and computer software)

    Time frame: 3 months post surgery

    Only at main center

  3. Quality of life related questionnaires

    Time frame: 24 months post surgery

  4. Correlation between cytokines and Holgers index

    Time frame: 24 months post surgery

  5. Correlation IS-pro profile and Holgers index

    Time frame: 24 months post surgery

  6. Development of a peri-implant dermatitis scale and compare it to the Holgers Index

    Time frame: 24 months post surgery

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Acronym: C50

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
May 8, 2015
Registry last updated
Sep 3, 2019

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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