Conductive Hearing Loss, Mixed Conductive-sensorineural Hearing Loss, Unilateral Partial Deafness
Conditions
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.
Interventions
PROCEDURESurgery for Ponto bone anchored hearing aids
Sponsors
Oticon Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of inflammation (Holgers index ≥ 2) | 3 months post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Soft tissue overgrowth (mm) | 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 | — |
| Cosmetic result (10 point scale) | 24 months post surgery | Scored using a 10-point scale and are compared to the healthy, normal contralateral situation |
| 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 | — |
| Extrusion rate (number of implants lost) | 3 months post surgery | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life related questionnaires | 24 months post surgery | — |
| Correlation between cytokines and Holgers index | 24 months post surgery | — |
| Correlation IS-pro profile and Holgers index | 24 months post surgery | — |
| Development of a peri-implant dermatitis scale and compare it to the Holgers Index | 24 months post surgery | — |
| Dynamic skin motion (analysed descriptively using photographs and computer software) | 3 months post surgery | Only at main center |
| Skin position (analysed descriptively using photographs and computer software) | 3 months post surgery | Only at main center |
Countries
Netherlands
Outcome results
None listed