Clinical trial NCT02438618: Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
Official title: Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conductive Hearing Loss
Unilateral Partial Deafness
Mixed Conductive-sensorineural Hearing Loss
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2015-05-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Incidence of inflammation (Holgers index ≥ 2)
timeFrame: 3 months post surgery
Secondary outcomes:
measure: Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))
timeFrame: 3 months post surgery
measure: Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
timeFrame: 3 months post surgery
measure: Loss of sensibility (Measured in mm outwards from the abutment)
timeFrame: 3 months post surgery
measure: Soft tissue overgrowth (mm)
timeFrame: 3 months post surgery
measure: Extrusion rate (number of implants lost)
timeFrame: 3 months post surgery
measure: Implant stability quotient (ISQ) measurements (ISQ units 1-100)
timeFrame: 3 months post surgery
measure: Surgical time (minutes)
timeFrame: 3 months post surgery
measure: Wound healing time (time to reach healed)
timeFrame: 3 months post surgery
measure: Holgers index ≥ 2 at any time point
timeFrame: 24 months post surgery
measure: Presence of dehiscence after surgery (present/not present)
timeFrame: 24 months post surgery
measure: Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
timeFrame: 24 months post surgery
measure: Loss of sensibility (Measured in mm outwards from the abutment)
timeFrame: 24 months post surgery
measure: Soft tissue overgrowth (mm)
timeFrame: 24 months post surgery
measure: Extrusion rate (number of implants lost)
timeFrame: 24 months post surgery
measure: Implant stability quotient (ISQ) measurements (ISQ units 1-100)
timeFrame: 24 months post surgery
measure: Cosmetic result (10 point scale)
timeFrame: 24 months post surgery
Other outcomes:
measure: Skin position (analysed descriptively using photographs and computer software)
timeFrame: 3 months post surgery
measure: Dynamic skin motion (analysed descriptively using photographs and computer software)
timeFrame: 3 months post surgery
measure: Quality of life related questionnaires
timeFrame: 24 months post surgery
measure: Correlation between cytokines and Holgers index
timeFrame: 24 months post surgery
measure: Correlation IS-pro profile and Holgers index
timeFrame: 24 months post surgery
measure: Development of a peri-implant dermatitis scale and compare it to the Holgers Index
timeFrame: 24 months post surgery
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Centre (MUMC+)
name: Robert Stokroos, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.