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The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive punch technique | Experimental | New surgical technique for Ponto bone anchored hearing implants |
|
| Hultcrantz technique | Other | Standard surgical technique for bone anchored hearing implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery for Ponto bone anchored hearing aids | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of inflammation (Holgers index ≥ 2) | 3 months post surgery |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin position (analysed descriptively using photographs and computer software) | Only at main center | 3 months post surgery |
| Dynamic skin motion (analysed descriptively using photographs and computer software) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Stokroos, Professor | Maastricht University Medical Centre (MUMC+) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Centre | Maastricht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37400140 | Derived | Strijbos RM, Straatman LV, Stegeman I, Holmberg M, Johansson ML, Stokroos RJ. Health Economic Cost Analysis for Percutaneous Bone Conduction Devices: The Minimally Invasive Ponto Surgery Versus Linear Incision Technique with Tissue Preservation. Otol Neurotol. 2023 Aug 1;44(7):709-717. doi: 10.1097/MAO.0000000000003939. Epub 2023 Jun 29. | |
| 33716934 |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| 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 |
Only at main center
| 3 months post surgery |
| 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 |
| Strijbos RM, Straatman LV, Calon TGA, Johansson ML, de Bruijn AJG, van den Berge H, Wagenaar M, Eichhorn E, Janssen M, Jonhede S, van Tongeren J, Holmberg M, Stokroos R. Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices. Front Neurol. 2021 Feb 24;12:632987. doi: 10.3389/fneur.2021.632987. eCollection 2021. |
| 27829464 | Derived | Calon TG, van Hoof M, van den Berge H, de Bruijn AJ, van Tongeren J, Hof JR, Brunings JW, Jonhede S, Anteunis LJ, Janssen M, Joore MA, Holmberg M, Johansson ML, Stokroos RJ. Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial. Trials. 2016 Nov 9;17(1):540. doi: 10.1186/s13063-016-1662-0. |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |