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Conductive Hearing LossNCT02064478

Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

An observational study of Conductive Hearing Loss and Mixed Hearing Loss, run by Oticon Medical at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness. With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. Read more about this study

Who is it for?
Ages 18 years and older
How many people
25 participants
Where
1 siteNetherlands
Study dates
Feb 2014to Sep 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients to be included are already planned for treatment with a bone anchored hearing aid at Radboud University Nijmegen Medical Centre (Nijmegen, The Netherlands).

Who may be able to join

  • 18 years or older
  • Patient indicated for an ear level bone anchored sound processor
  • Bone thickness at the implant site of at least 4 mm

Who cannot join

  • Inability to participate in follow-up
  • Psychiatric disease in the medical history
  • Mental disability
  • Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
  • Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
  • Patients with natural skin height of >10 mm

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University Medical Centre

    Nijmegen, 6500 HB

Other trials in Netherlands

About this study

A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness.

With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study.

The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.

Keywords
Bone anchored hearing implant, Bone anchored hearing device
Medical subject headings
Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02064478
Study groupRoleWhat they receive
Tissue preservationPonto implant installed using a tissue preservation surgical technique
Tissue reductionPonto implant installed using a classical technique with skin thinning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numbness around implant, specifically mean Total sensibility

    Measured: 36 months after surgery

Secondary outcomes (48)

  1. Length of surgery

    Measured: At surgery

  2. Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient

    Measured: 0-6 months

  3. Mild/Adverse skin reaction

    Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period Holgers score is a standardized score of skin reactions around a bone anchored hearing implant.

    Measured: 0-6 months

  4. Skin condition according to Holgers

    Holgers score is a standardized score of skin reactions around a bone anchored hearing implant.

    Measured: 7 days after surgery

  5. Postoperative complications

    Including

    • Bleeding or hematoma
    • Flap necrosis
    • Wound dehiscence
    • Other (description)

    Measured: 7 days to 6 months

  6. Proportion of patients with complete wound healing at first surgical visit

    Measured: 7 days

  7. Glasgow Benefit Inventory (GBI) scores

    Measured: 3 months

  8. Glasgow Health Status Inventory (GHSI) scores

    Measured: Baseline (before surgery)

  9. Abbreviated profile of hearing aid benefit (APHAB) scores

    Measured: Baseline (before surgery)

  10. Mean hours of use of the sound processor

    Measured: 0-6 months

  11. Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient

    Measured: 0-12 months

  12. Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient

    Measured: 0-36 months

  13. Bone conduction (BC) in-situ audiometric thresholds

    Measured: 6 months

  14. Bone conduction (BC) audiometric threshold

    Measured with B-71

    Measured: 6 months

  15. Mean total sensibility around implant

    Measured: Baseline (before surgery)

  16. Implant stability quotient (ISQ)

    Measured: At surgery

  17. Time to implant loss

    Measured: 0-36 months

  18. Patient and Observer scar assessment score

    Measured: 21 days post surgery

  19. Mild/Adverse skin reaction

    Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period

    Measured: 0-12 months

  20. Mild/Adverse skin reaction

    Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period

    Measured: 0-36 months

  21. Skin condition according to Holgers

    Measured: 21 days

  22. Skin condition according to Holgers

    Measured: 12 weeks

  23. Skin condition according to Holgers

    Measured: 6 months

  24. Skin condition according to Holgers

    Measured: 1 year

  25. Skin condition according to Holgers

    Measured: 2 years

  26. Skin condition according to Holgers

    Measured: 3 years after surgery

  27. Postoperative complications

    Including

    • Bleeding or hematoma
    • Flap necrosis
    • Wound dehiscence
    • Other (description)

    Measured: 7 days to 12 months

  28. Postoperative complications

    Including

    • Bleeding or hematoma
    • Flap necrosis
    • Wound dehiscence
    • Other (description)

    Measured: 7 days to 36 months

  29. Glasgow Benefit Inventory (GBI) scores

    Measured: 12 months

  30. Glasgow Health Status Inventory (GHSI) scores

    Measured: 6 months

  31. Glasgow Health Status Inventory (GHSI) scores

    Measured: 36 months

  32. Abbreviated profile of hearing aid benefit (APHAB) scores

    Measured: 6 months

  33. Abbreviated profile of hearing aid benefit (APHAB) scores

    Measured: 36 months

  34. Mean hours of use of the sound processor

    Measured: 0-36 months

  35. Mean total sensibility around implant

    Measured: 21 days

  36. Mean total sensibility around implant

    Measured: 6 months

  37. Mean total sensibility around implant

    Measured: 12 months

  38. Mean total sensibility around implant

    Measured: 36 months

  39. Implant stability quotient (ISQ)

    Measured: 7 days post surgery

  40. Implant stability quotient (ISQ)

    Measured: 21 days post surgery

  41. Implant stability quotient (ISQ)

    Measured: 12 weeks post surgery

  42. Implant stability quotient (ISQ)

    Measured: 6 months post surgery

  43. Implant stability quotient (ISQ)

    Measured: 12 months post surgery

  44. Implant stability quotient (ISQ)

    Measured: 24 months post surgery

  45. Implant stability quotient (ISQ)

    Measured: 36 months post surgery

  46. Patient and Observer scar assessment score

    Measured: 6 months

  47. Patient and Observer scar assessment score

    Measured: 12 months

  48. Patient and Observer scar assessment score

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionApr 2015
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02064478
Sponsor's protocol ID
C47
Status last verified
Feb 2018
First submitted
14 Feb 2014
Last updated
22 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • den Besten CA, Bosman AJ, Nelissen RC, Mylanus EA, Hol MK. Controlled Clinical Trial on Bone-anchored Hearing Implants and a Surgical Technique With Soft-tissue Preservation. Otol Neurotol. 2016 Jun;37(5):504-12. doi: 10.1097/MAO.0000000000000994.

    PubMed 26945315

Questions about this trial

What is this clinical trial studying?

An observational study of Conductive Hearing Loss and Mixed Hearing Loss, run by Oticon Medical at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numbness around implant, specifically mean Total sensibility (time frame: 36 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02064478, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.

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