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Completed

NCT Number: NCT04279236

Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)

This prospective, multi-center study funded by Oticon Medical AB will be conducted at six clinical sites in North America. Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The total number of participants included in the study will be 64.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS).

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada

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About this study

This prospective, multi-centre study funded by Oticon Medical AB will be conducted at six clinical sites in North America. Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The total number of participants included in the study will be 64. Patients who are withdrawn from the study prior to completion will not be replaced.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS). The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Patient indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines.
  • Normal bone quality and bone thickness above 3 mm, where no complications during surgery are expected.
  • Skin thickness of 12mm or less at the implant site

Exclusion criteria

  • Patients undergoing re-implantation
  • Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
  • Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
  • Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator.
  • Any other known condition that the investigator determines could interfere with compliance or study assessments.

Treatment and study plan

Abbreviated Profile Hearing Aid Benefit (APHAB)

Other

An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on 2 occasions.

Glasgow Benefit Inventory (GBI)

Other

An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on 2 occasions.

Additional follow-up visit

Other

There is an additional follow-up visit after surgery (compared to the routine clinical practice of the surgeons/clinics).

Primary outcomes

  1. Implant/abutment complex capability to provide reliable anchorage for sound processor

    Time frame: 3 months after implant surgery (MIPS)

    The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable. without any adverse skin reactions or skin over-growth and pain preventing usage of the sound processor.

Secondary outcomes

  1. Implant/abutment complex capability to provide reliable anchorage for sound processor

    Time frame: 12 months after implant surgery (MIPS)

    The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable without any adverse skin reactions or skin over-growth and pain preventing usage of the sound processor.

  2. Implant survival

    Time frame: 12 months after implant surgery (MIPS)

    Implant survival will be assessed by the investigator by means of a Yes/No question: Implant/abutment complex in place [Yes/No]

  3. Implant stability

    Time frame: 12 months after implant surgery (MIPS)

    Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No]

  4. Holgers score ratings

    Time frame: 12 months after implant surgery (MIPS)

    Distribution of Holgers score ratings (scale 0-4) where a higher score corresponds to a poorer outcome, assigned by investigator

  5. IPS scores

    Time frame: 12 months after implant surgery (MIPS)

    Distribution of IPS (Inflammation [total score 0-4], Pain [score 0-2], Skin height [score 0-2]) scores assigned by investigator. The IPS score is presented as [Ix Px Sx] with x being the individual score for each parameter. A higher score corresponds to a poorer outcome

  6. Patient-perceived presence of pain around implant/abutment

    Time frame: 12 months after implant surgery (MIPS)

    Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject

  7. Patient-perceived magnitude of pain around implant/abutment

    Time frame: 12 months after implant surgery (MIPS)

    Assessment of magnitude of patient-perceived pain using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome

  8. Patient-perceived presence of numbness around implant/abutment

    Time frame: 12 months after implant surgery (MIPS)

    Assessment of presence of patient-perceived numbness by means of a Yes/No question to the subject

  9. Patient-perceived magnitude of numbness around implant/abutment

    Time frame: 12 months after implant surgery (MIPS)

    Assessment of magnitude of patient-perceived numbness using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome

  10. Skin/soft tissue overgrowth

    Time frame: 12 months after implant surgery (MIPS)

    Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question

  11. Duration of surgery

    Time frame: At implant surgery (MIPS)

    Length of surgery measured in minutes

  12. Wound dehiscence

    Time frame: 12 months after implant surgery (MIPS)

    Prevalence of wound dehiscence measured as millimeters of dehiscence

  13. Wound healing time

    Time frame: 12 months after implant surgery (MIPS)

    Average healing time [days] from surgery when the wound is considered healed

  14. Implant/abutment usage

    Time frame: 12 months after implant surgery (MIPS)

    Mean hours of use of a sound processor on the implant/abutment

  15. Subjective benefit after MIPS surgery

    Time frame: At screening visit (visit before surgery)

    Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a global higher score corresponds to a poorer outcome

  16. Subjective benefit after MIPS surgery

    Time frame: 6 months after implant surgery (MIPS)

    Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a higher global score corresponds to a poorer outcome

  17. Subjective benefit after MIPS surgery

    Time frame: 3 months after implant surgery (MIPS)

    Glasgow Benefit Inventory (GBI) questionnaire score (-100 to +100) where [-100] means maximum adverse effect, [0] means no effect, and [+100] means maximum positive effect

  18. Subjective benefit after MIPS surgery

    Time frame: 12 months after implant surgery (MIPS)

    Glasgow Benefit Inventory (GBI) questionnaire score (-100 to +100) where [-100] means maximum adverse effect, [0] means no effect, and [+100] means maximum positive effect

Other outcomes

  1. Safety outcome

    Time frame: 12 months after implant surgery (MIPS)

    Occurrence and severity of both related and unrelated adverse events after MIPS surgery

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

A Prospective Multi-Center Study on the Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (MIPS)

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2020
Registry last updated
Jan 27, 2025

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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