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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 : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Oticon Medical

Tracking Information
First Submitted Date February 17, 2020
First Posted Date February 21, 2020
Last Update Posted Date December 17, 2021
Actual Study Start Date June 15, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 19, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 19, 2020)
  • 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.
  • 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]
  • 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]
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Duration of surgery [ Time Frame: At implant surgery (MIPS) ]
    Length of surgery measured in minutes
  • Wound dehiscence [ Time Frame: 12 months after implant surgery (MIPS) ]
    Prevalence of wound dehiscence measured as millimeters of dehiscence
  • Wound healing time [ Time Frame: 12 months after implant surgery (MIPS) ]
    Average healing time [days] from surgery when the wound is considered healed
  • Implant/abutment usage [ Time Frame: 12 months after implant surgery (MIPS) ]
    Mean hours of use of a sound processor on the implant/abutment
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 19, 2020)
Safety outcome [ Time Frame: 12 months after implant surgery (MIPS) ]
Occurrence and severity of both related and unrelated adverse events after MIPS surgery
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)
Official Title A Prospective Multi-Center Study on the Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (MIPS)
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).

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hearing Loss
Intervention
  • 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).
Study Groups/Cohorts 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.
Interventions:
  • Other: Abbreviated Profile Hearing Aid Benefit (APHAB)
  • Other: Glasgow Benefit Inventory (GBI)
  • Other: Additional follow-up visit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 19, 2020)
64
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Maria Aaberg Haakansson, PhL 0046761918916 mbae@oticonmedical.com
Listed Location Countries Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04279236
Other Study ID Numbers Doc-00066191
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Oticon Medical
Study Sponsor Oticon Medical
Collaborators Not Provided
Investigators Not Provided
PRS Account Oticon Medical
Verification Date November 2021