Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.

Official Title
-----------------
Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants

Conditions
-----------------
Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Conductive-sensorineural Hearing Loss

Intervention / Treatment
-----------------
* Procedure: Surgery for Ponto bone anchored hearing aids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient, i.e. ≥ 18 years of age Eligible for the Ponto system Exclusion Criteria: Known history of immunosuppressive disease Use of systemic immunosuppressive medication Receiving bilateral bone anchored hearing system Relevant dermatological diseases as judged by the investigator Not being able to finish the study, for example because of failure to complete the questionnaires Participating in another study with medical aids or medication When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally invasive punch technique<br>New surgical technique for Ponto bone anchored hearing implants | Procedure: Surgery for Ponto bone anchored hearing aids<br> <br> |
| Other: Hultcrantz technique<br>Standard surgical technique for bone anchored hearing implants | Procedure: Surgery for Ponto bone anchored hearing aids<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of inflammation (Holgers index ≥ 2) |  | 3 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of dehiscence after surgery (Noted in a binary fashion (present/not present)) |  | 3 months post surgery | 
| Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10) |  | 3 months post surgery | 
| Loss of sensibility (Measured in mm outwards from the abutment) |  | 3 months post surgery | 
| Soft tissue overgrowth (mm) |  | 3 months post surgery | 
| Extrusion rate (number of implants lost) |  | 3 months post surgery | 
| Implant stability quotient (ISQ) measurements (ISQ units 1-100) |  | 3 months post surgery | 
| Surgical time (minutes) |  | 3 months post surgery | 
| Wound healing time (time to reach healed) |  | 3 months post surgery | 
| Holgers index ≥ 2 at any time point |  | 24 months post surgery | 
| Presence of dehiscence after surgery (present/not present) |  | 24 months post surgery | 
| Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10) |  | 24 months post surgery | 
| Loss of sensibility (Measured in mm outwards from the abutment) |  | 24 months post surgery | 
| Soft tissue overgrowth (mm) |  | 24 months post surgery | 
| Extrusion rate (number of implants lost) |  | 24 months post surgery | 
| Implant stability quotient (ISQ) measurements (ISQ units 1-100) | Measured in ISQ units (1-100) | 24 months post surgery | 
| Cosmetic result (10 point scale) | Scored using a 10-point scale and are compared to the healthy, normal contralateral situation | 24 months post surgery |