Back to resultsPonto Implantation Using a Minimally Invasive Surgical Technique
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Minimally invasive surgery
Glasgow Benefit Inventory (GBI)
Additional follow-up visits after surgery
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Patient indicated for surgical intervention with a bone anchored hearing system
- Signed informed consent
- Adequate bone quality to allow for a Ponto implant insertion, as judged by the investigator, and an expected bone thickness above 5 mm, where no complications during surgery are expected
- Skin thickness of 12 mm or less at the implant site
Exclusion Criteria:
- Patient undergoing re-implantation
- Patient who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales
- Known condition or previous treatment that could jeopardize skin condition and wound healing over time as judged by the investigator (e.g. uncontrolled diabetes, previous radiotherapy in the area of interest)
- Known medical condition that contraindicate surgery as judged by the investigator
- Known and/or planned pregnancy at time of surgery
- Any other known condition that the investigator determines could interfere with compliance or investigation assessments
- Simultaneous participation in another clinical investigation with pharmaceutical and/or medical device which might cause interference with investigation participation
Sites / Locations
- Aalborg University Hospital
- Univerisity Medical Center Groningen
- Radboud University Medical Center
- Sahlgrenska University Hospital
- University Hospitals Birmingham NHS Foundation Trust
- Cambridge University Hospitals NHS Foundation Trust
- Guy's and St Thomas' NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single-arm
Arm Description
In this single-arm study the patients will be undergoing a minimally invasive surgery after which they will re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
Outcomes
Primary Outcome Measures
Implant/abutment complex capability to provide a reliable anchorage for a sound processor
The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth 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, skin overgrowth or pain preventing usage of the sound processor.
Secondary Outcome Measures
Implant/abutment complex capability to provide reliable anchorage for sound processor
The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor.
Implant survival
Implant survival will be assessed by the investigator by means of a Yes/No question: Implant in place [Yes/No]
Implant stability
Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No]
Holgers score distribution
Distribution of Holgers score ratings (scale 0-4), where a higher score corresponds to a poorer outcome, assigned by investigator.
Max Holgers score
Max Holgers score rating (scale 0-4) per patient across study visits, where a higher score corresponds to a poorer outcome, assigned by investigator.
Mild/Adverse skin reaction
Mild/Adverse skin reaction per patient across study visits, where adverse skin reaction is defined as Holgers ≥ 2 on at least one follow-up visit.
IPS (Inflammation, Pain, Skin height) scores
Distribution of IPS scores (Inflammation score 0-4; Pain score 0-2; Skin height score 0-2) 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.
Wound healing
Investigator assessment of wound being completely healed by means of a Yes/No question.
Skin dehiscence
Prevalence of skin dehiscence around the abutment measured as millimeters of dehiscence.
Skin overgrowth
Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question.
Post-operative events around abutment
Assessment of post-operative events by the investigator.
Patient-perceived presence of pain around abutment
Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject.
Patient-perceived magnitude of pain around abutment
Assessment of magnitude of patient-perceived pain using a numerical rating scale (range 0-10), where a higher rating corresponds to a poorer outcome.
Patient-perceived presence of numbness around abutment
Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient.
Patient-perceived magnitude of numbness around abutment
Assessment of magnitude of patient-perceived numbness using a numerical rating scale (range 0-10), where a higher rating corresponds to a poorer outcome.
Duration of surgery
Length of surgery measured in minutes.
Sound processor usage
Average sound processor usage time.
Subjective benefit after surgery
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04606823
Brief Title
Ponto Implantation Using a Minimally Invasive Surgical Technique
Official Title
Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique - a Prospective Multicentre Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
August 9, 2022 (Actual)
Study Completion Date
April 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.
The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique.
Detailed Description
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.
The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique. 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 three months after implantation/surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-arm
Arm Type
Other
Arm Description
In this single-arm study the patients will be undergoing a minimally invasive surgery after which they will re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive surgery
Intervention Description
The subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery.
Intervention Type
Other
Intervention Name(s)
Glasgow Benefit Inventory (GBI)
Intervention Description
A quality of life-questionnaire is to be completed by the subjects at one occasion.
Intervention Type
Other
Intervention Name(s)
Additional follow-up visits after surgery
Intervention Description
There are 1-3 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).
Primary Outcome Measure Information:
Title
Implant/abutment complex capability to provide a reliable anchorage for a sound processor
Description
The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth 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, skin overgrowth or pain preventing usage of the sound processor.
Time Frame
3 months after implant surgery
Secondary Outcome Measure Information:
Title
Implant/abutment complex capability to provide reliable anchorage for sound processor
Description
The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor.
Time Frame
12 months after implant surgery
Title
Implant survival
Description
Implant survival will be assessed by the investigator by means of a Yes/No question: Implant in place [Yes/No]
Time Frame
12 months after implant surgery
Title
Implant stability
Description
Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No]
Time Frame
12 months after implant surgery
Title
Holgers score distribution
Description
Distribution of Holgers score ratings (scale 0-4), where a higher score corresponds to a poorer outcome, assigned by investigator.
Time Frame
12 months after implant surgery
Title
Max Holgers score
Description
Max Holgers score rating (scale 0-4) per patient across study visits, where a higher score corresponds to a poorer outcome, assigned by investigator.
Time Frame
12 months after implant surgery
Title
Mild/Adverse skin reaction
Description
Mild/Adverse skin reaction per patient across study visits, where adverse skin reaction is defined as Holgers ≥ 2 on at least one follow-up visit.
Time Frame
12 months after implant surgery
Title
IPS (Inflammation, Pain, Skin height) scores
Description
Distribution of IPS scores (Inflammation score 0-4; Pain score 0-2; Skin height score 0-2) 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.
Time Frame
12 months after implant surgery
Title
Wound healing
Description
Investigator assessment of wound being completely healed by means of a Yes/No question.
Time Frame
12 months after implant surgery
Title
Skin dehiscence
Description
Prevalence of skin dehiscence around the abutment measured as millimeters of dehiscence.
Time Frame
12 months after implant surgery
Title
Skin overgrowth
Description
Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question.
Time Frame
12 months after implant surgery
Title
Post-operative events around abutment
Description
Assessment of post-operative events by the investigator.
Time Frame
12 months after implant surgery
Title
Patient-perceived presence of pain around abutment
Description
Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject.
Time Frame
12 months after implant surgery
Title
Patient-perceived magnitude of pain around abutment
Description
Assessment of magnitude of patient-perceived pain using a numerical rating scale (range 0-10), where a higher rating corresponds to a poorer outcome.
Time Frame
12 months after implant surgery
Title
Patient-perceived presence of numbness around abutment
Description
Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient.
Time Frame
12 months after implant surgery
Title
Patient-perceived magnitude of numbness around abutment
Description
Assessment of magnitude of patient-perceived numbness using a numerical rating scale (range 0-10), where a higher rating corresponds to a poorer outcome.
Time Frame
12 months after implant surgery
Title
Duration of surgery
Description
Length of surgery measured in minutes.
Time Frame
3 months after implant surgery
Title
Sound processor usage
Description
Average sound processor usage time.
Time Frame
12 months after implant surgery
Title
Subjective benefit after surgery
Description
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.
Time Frame
3 months after surgery
Other Pre-specified Outcome Measures:
Title
Safety outcome - Adverse events
Description
Number and severity of adverse events related to the investigational device and corresponding procedures.
Time Frame
12 months after surgery
Title
Safety outcome - Device deficiences
Description
Number and severity of device deficiencies.
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Patient indicated for surgical intervention with a bone anchored hearing system
Signed informed consent
Adequate bone quality to allow for a Ponto implant insertion, as judged by the investigator, and an expected bone thickness above 5 mm, where no complications during surgery are expected
Skin thickness of 12 mm or less at the implant site
Exclusion Criteria:
Patient undergoing re-implantation
Patient who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales
Known condition or previous treatment that could jeopardize skin condition and wound healing over time as judged by the investigator (e.g. uncontrolled diabetes, previous radiotherapy in the area of interest)
Known medical condition that contraindicate surgery as judged by the investigator
Known and/or planned pregnancy at time of surgery
Any other known condition that the investigator determines could interfere with compliance or investigation assessments
Simultaneous participation in another clinical investigation with pharmaceutical and/or medical device which might cause interference with investigation participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Powell, MD
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Univerisity Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6525EX
Country
Netherlands
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2WB
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
12. IPD Sharing Statement
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Ponto Implantation Using a Minimally Invasive Surgical Technique
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