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Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants (C50)

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ClinicalTrials.gov Identifier: NCT02438618
Recruitment Status : Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Oticon Medical

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

Condition or disease Intervention/treatment Phase
Conductive Hearing Loss Unilateral Partial Deafness Mixed Conductive-sensorineural Hearing Loss Procedure: Surgery for Ponto bone anchored hearing aids Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
Actual Study Start Date : October 2014
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minimally invasive punch technique
New surgical technique for Ponto bone anchored hearing implants
Procedure: Surgery for Ponto bone anchored hearing aids
Hultcrantz technique
Standard surgical technique for bone anchored hearing implants
Procedure: Surgery for Ponto bone anchored hearing aids



Primary Outcome Measures :
  1. Incidence of inflammation (Holgers index ≥ 2) [ Time Frame: 3 months post surgery ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438618


Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Sponsors and Collaborators
Oticon Medical
Investigators
Principal Investigator: Robert Stokroos, Professor Maastricht University Medical Centre (MUMC+)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT02438618     History of Changes
Other Study ID Numbers: C50
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms