Ponto Implantation Using a Minimally Invasive Surgical Technique

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique - a Prospective Multicentre Study

Conditions
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Hearing Loss

Intervention / Treatment
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* Procedure: Minimally invasive surgery
* Other: Glasgow Benefit Inventory (GBI)
* Other: Additional follow-up visits after surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-arm<br>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. | Procedure: Minimally invasive surgery<br>* The subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery.<br>Other: Glasgow Benefit Inventory (GBI)<br>* A quality of life-questionnaire is to be completed by the subjects at one occasion.<br>Other: Additional follow-up visits after surgery<br>* There are 1-3 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months after implant surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months after implant surgery | 
| Implant survival | Implant survival will be assessed by the investigator by means of a Yes/No question: Implant in place [Yes/No] | 12 months after implant surgery | 
| Implant stability | Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No] | 12 months after implant surgery | 
| Holgers score distribution | Distribution of Holgers score ratings (scale 0-4), where a higher score corresponds to a poorer outcome, assigned by investigator. | 12 months after implant surgery | 
| 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. | 12 months after implant surgery | 
| 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. | 12 months after implant surgery | 
| 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. | 12 months after implant surgery | 
| Wound healing | Investigator assessment of wound being completely healed by means of a Yes/No question. | 12 months after implant surgery | 
| Skin dehiscence | Prevalence of skin dehiscence around the abutment measured as millimeters of dehiscence. | 12 months after implant surgery | 
| Skin overgrowth | Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question. | 12 months after implant surgery | 
| Post-operative events around abutment | Assessment of post-operative events by the investigator. | 12 months after implant surgery | 
| Patient-perceived presence of pain around abutment | Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject. | 12 months after implant surgery | 
| 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. | 12 months after implant surgery | 
| Patient-perceived presence of numbness around abutment | Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient. | 12 months after implant surgery | 
| 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. | 12 months after implant surgery | 
| Duration of surgery | Length of surgery measured in minutes. | 3 months after implant surgery | 
| Sound processor usage | Average sound processor usage time. | 12 months after implant surgery | 
| 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. | 3 months after surgery |