Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration

Study Overview
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Brief Summary
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The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.

Official Title
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Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration

Conditions
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Bone Conduction Deafness, Unilateral Deafness, Middle Ear Deafness, Mixed Hearing Loss

Intervention / Treatment
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* Device: Minimally Invasive Ponto Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older. Patient indicated for an ear level bone anchored sound processor. Healthy bone quality to allow for 4mm implant insertion. Exclusion Criteria: Intraoperative switch to an alternative surgical technique Patients undergoing re-implantation (on the side being included in the study) Previous participation in the C47 study. Inability to participate in follow-up. Psychiatric disease in the medical history. Mental disability. Presumed doubt, for any reason, that the patient will be able to show up on all follow-ups. Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus. Patients with natural skin height of >12mm (as there will be additional skin reduction needed)

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: Minimally Invasive Ponto Surgery<br>Surgical method for installation of a bone anchored hearing system for hearing rehabilitation | Device: Minimally Invasive Ponto Surgery<br>* Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbness (sensibility) around the implant | Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility. | 6 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of surgery | Compare the surgical time between test (this investigation) and control group (previous investigation, C47). | At surgery | 
| Unplanned visits | Investigate and compare the number of unplanned visits, including unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47). | 36 months | 
| Adverse skin reactions | Investigate and compare the rate of adverse skin reactions using the Holgers Scale. | 36 months | 
| Adverse skin reactions | Investigate and compare the rate of adverse skin reactions using the IPS scale. | 36 months | 
| Pain perception by patient | Investigate and compare pain using a visual analogue scale 0-10 | 36 months | 
| Implant survivability | Investigate and compare implant survivability in terms of reported implant loss. | 36 months | 
| Implant stability as measured with resonance frequency analysis, RFA. | Investigate and compare implant stability. Implant stability is monitored by measuring the implant stability quotient when following up on patients. Stability will be reported as implant stability quotient (ISQ). | 36 months | 
| Surgical wound healing time | Investigate and compare healing time after surgery. Follow-up visits after surgery will assess the healing of wound. This will be a yes/no assessment to be answered by the attending physician. The investigators will also evaluate skin reactions and record any medications that were given to aid in skin healing. | 36 months | 
| Wound dehiscence | Investigate wound dehiscence size after surgery. | 36 months | 
| Quality of Life Assessment | Investigate and compare subjective benefit as measured by SSQ questionnaire. | 36 months | 
| Quality of Life Assessment | Investigate and compare subjective benefit as measured by YORK questionnaire. | 36 months | 
| Quality of Life Assessment | Investigate and compare subjective benefit as measured by APHAB questionnaire. | 36 months | 
| Quality of Life Assessment | Investigate and compare subjective benefit as measured by GBI questionnaire. | 36 months | 
| Quality of Life Assessment | Investigate and compare subjective benefit as measured by GHSI questionnaire. | 36 months |