Ponto Implantation Using a Minimally Invasive Surgical Technique
- Conditions
- Hearing Loss
- Interventions
- Procedure: Minimally invasive surgeryOther: Glasgow Benefit Inventory (GBI)Other: Additional follow-up visits after surgery
- Registration Number
- NCT04606823
- Lead Sponsor
- Oticon Medical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-arm Additional follow-up visits after surgery 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. Single-arm Minimally invasive surgery 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. Single-arm Glasgow Benefit Inventory (GBI) 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.
- Primary Outcome Measures
Name Time Method Implant/abutment complex capability to provide a reliable anchorage for a sound processor 3 months after implant surgery 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
Name Time Method Implant/abutment complex capability to provide reliable anchorage for sound processor 12 months after implant surgery 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.
Holgers score distribution 12 months after implant surgery Distribution of Holgers score ratings (scale 0-4), where a higher score corresponds to a poorer outcome, assigned by investigator.
Wound healing 12 months after implant surgery Investigator assessment of wound being completely healed by means of a Yes/No question.
Patient-perceived presence of pain around abutment 12 months after implant surgery Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject.
Patient-perceived magnitude of numbness around abutment 12 months after implant surgery Assessment of magnitude of patient-perceived numbness using a numerical rating scale (range 0-10), where a higher rating corresponds to a poorer outcome.
Implant survival 12 months after implant surgery Implant survival will be assessed by the investigator by means of a Yes/No question: Implant in place \[Yes/No\]
Mild/Adverse skin reaction 12 months after implant surgery 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.
Skin dehiscence 12 months after implant surgery Prevalence of skin dehiscence around the abutment measured as millimeters of dehiscence.
Duration of surgery 3 months after implant surgery Length of surgery measured in minutes.
Subjective benefit after surgery 3 months 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.
Implant stability 12 months after implant surgery Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable \[Yes/No\]
IPS (Inflammation, Pain, Skin height) scores 12 months after implant surgery 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.
Skin overgrowth 12 months after implant surgery Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question.
Max Holgers score 12 months after implant surgery Max Holgers score rating (scale 0-4) per patient across study visits, where a higher score corresponds to a poorer outcome, assigned by investigator.
Patient-perceived magnitude of pain around abutment 12 months after implant surgery 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 12 months after implant surgery Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient.
Sound processor usage 12 months after implant surgery Average sound processor usage time.
Post-operative events around abutment 12 months after implant surgery Assessment of post-operative events by the investigator.
Trial Locations
- Locations (7)
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Univerisity Medical Center Groningen
🇳🇱Groningen, Netherlands
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom