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

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ClinicalTrials.gov Identifier: NCT04279236
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : October 4, 2022
Sponsor:
Information provided by (Responsible Party):
Oticon Medical

Study Description
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Brief Summary:

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).


Condition or disease Intervention/treatment
Hearing Loss Other: Abbreviated Profile Hearing Aid Benefit (APHAB) Other: Glasgow Benefit Inventory (GBI) Other: Additional follow-up visit

Detailed Description:

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 Patients who are withdrawn from the study prior to completion will not be replaced.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.

Study Design
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Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multi-Center Study on the Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (MIPS)
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Single-arm
In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and an additional follow-up visit after surgery.
 Other: Abbreviated Profile Hearing Aid Benefit (APHAB)
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.

Other: Glasgow Benefit Inventory (GBI)
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.

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Safety outcome [ Time Frame: 12 months after implant surgery (MIPS) ]
    Occurrence and severity of both related and unrelated adverse events after MIPS surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to participating clinics who meet clinical indications for surgical intervention with a bone anchored hearing system.
Criteria

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.
Contacts and Locations
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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): NCT04279236


Contacts
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Contact: Maria Aaberg Haakansson, PhL 0046761918916 mbae@oticonmedical.com

Locations
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United States, Florida
Silverstein Institute Recruiting
Sarasota, Florida, United States, 34239
Contact: Amanda Brady    941-366-9222      
United States, Indiana
Otolaryngology Associates Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Stephanie Schutte    317-844-7059      
United States, New York
New York Eye and Ear Infirmary Terminated
New York, New York, United States, 10003
United States, Oregon
Northwest Ear Institute Recruiting
Portland, Oregon, United States, 97210
Contact: Harold Kim, MD    503-444-7676    nwearinstitute@gmail.com   
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Kutz         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23284
Contact: Margaret Zwicker    804-828-3966      
Canada, Quebec
The Research Institute of the McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3H 2R9
Contact: Sam J. Daniel, Dr         
Spain
Hospital Universitario de Donostia Recruiting
San Sebastián, Gipuzkoa, Spain, 20014
Contact: Altuna         
Sponsors and Collaborators
Oticon Medical
More Information
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Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT04279236    
Other Study ID Numbers: Doc-00066191
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases