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OpenTrials
Completed

NCT Number: NCT02064478

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

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.

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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 Single Sided Deafness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Medical Centre

Nijmegen, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Numbness around implant, specifically mean Total sensibility

    Time frame: 36 months after surgery

Secondary outcomes

  1. Length of surgery

    Time frame: At surgery

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

    Time frame: 0-6 months

  3. Mild/Adverse skin reaction

    Time frame: 0-6 months

    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.

  4. Skin condition according to Holgers

    Time frame: 7 days after surgery

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

  5. Postoperative complications

    Time frame: 7 days to 6 months

    Including

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

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

    Time frame: 7 days

  7. Glasgow Benefit Inventory (GBI) scores

    Time frame: 3 months

  8. Glasgow Health Status Inventory (GHSI) scores

    Time frame: Baseline (before surgery)

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

    Time frame: Baseline (before surgery)

  10. Mean hours of use of the sound processor

    Time frame: 0-6 months

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

    Time frame: 0-12 months

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

    Time frame: 0-36 months

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

    Time frame: 6 months

  14. Bone conduction (BC) audiometric threshold

    Time frame: 6 months

    Measured with B-71

  15. Mean total sensibility around implant

    Time frame: Baseline (before surgery)

  16. Implant stability quotient (ISQ)

    Time frame: At surgery

  17. Time to implant loss

    Time frame: 0-36 months

  18. Patient and Observer scar assessment score

    Time frame: 21 days post surgery

  19. Mild/Adverse skin reaction

    Time frame: 0-12 months

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

  20. Mild/Adverse skin reaction

    Time frame: 0-36 months

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

  21. Skin condition according to Holgers

    Time frame: 21 days

  22. Skin condition according to Holgers

    Time frame: 12 weeks

  23. Skin condition according to Holgers

    Time frame: 6 months

  24. Skin condition according to Holgers

    Time frame: 1 year

  25. Skin condition according to Holgers

    Time frame: 2 years

  26. Skin condition according to Holgers

    Time frame: 3 years after surgery

  27. Postoperative complications

    Time frame: 7 days to 12 months

    Including

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

  28. Postoperative complications

    Time frame: 7 days to 36 months

    Including

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

  29. Glasgow Benefit Inventory (GBI) scores

    Time frame: 12 months

  30. Glasgow Health Status Inventory (GHSI) scores

    Time frame: 6 months

  31. Glasgow Health Status Inventory (GHSI) scores

    Time frame: 36 months

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

    Time frame: 6 months

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

    Time frame: 36 months

  34. Mean hours of use of the sound processor

    Time frame: 0-36 months

  35. Mean total sensibility around implant

    Time frame: 21 days

  36. Mean total sensibility around implant

    Time frame: 6 months

  37. Mean total sensibility around implant

    Time frame: 12 months

  38. Mean total sensibility around implant

    Time frame: 36 months

  39. Implant stability quotient (ISQ)

    Time frame: 7 days post surgery

  40. Implant stability quotient (ISQ)

    Time frame: 21 days post surgery

  41. Implant stability quotient (ISQ)

    Time frame: 12 weeks post surgery

  42. Implant stability quotient (ISQ)

    Time frame: 6 months post surgery

  43. Implant stability quotient (ISQ)

    Time frame: 12 months post surgery

  44. Implant stability quotient (ISQ)

    Time frame: 24 months post surgery

  45. Implant stability quotient (ISQ)

    Time frame: 36 months post surgery

  46. Patient and Observer scar assessment score

    Time frame: 6 months

  47. Patient and Observer scar assessment score

    Time frame: 12 months

  48. Patient and Observer scar assessment score

    Time frame: 36 months

Other outcomes

  1. Skin height around abutment (in mm)

    Time frame: At surgery

  2. Skin height around abutment (in mm)

    Time frame: 7 days post surgery

  3. Skin height around abutment (in mm)

    Time frame: 21 days post surgery

  4. Skin height around abutment (in mm)

    Time frame: 12 weeks post surgery

  5. Skin height around abutment (in mm)

    Time frame: 6 months post surgery

  6. Skin height around abutment (in mm)

    Time frame: 12 months post surgery

  7. Skin height around abutment (in mm)

    Time frame: 36 months post surgery

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Collaborators

  • Statistiska Konsultgruppen

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Feb 17, 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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