Back to resultsMinimally Invasive Surgery for Ponto Bone Anchored Hearing Implants (C50)
Primary Purpose
Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Conductive-sensorineural Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Surgery for Ponto bone anchored hearing aids
Sponsored by
About this trial
This is an interventional supportive care trial for Conductive Hearing Loss
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.
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Minimally invasive punch technique
Hultcrantz technique
Arm Description
New surgical technique for Ponto bone anchored hearing implants
Standard surgical technique for bone anchored hearing implants
Outcomes
Primary Outcome Measures
Incidence of inflammation (Holgers index ≥ 2)
Secondary Outcome Measures
Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
Loss of sensibility (Measured in mm outwards from the abutment)
Soft tissue overgrowth (mm)
Extrusion rate (number of implants lost)
Implant stability quotient (ISQ) measurements (ISQ units 1-100)
Surgical time (minutes)
Wound healing time (time to reach healed)
Holgers index ≥ 2 at any time point
Presence of dehiscence after surgery (present/not present)
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
Loss of sensibility (Measured in mm outwards from the abutment)
Soft tissue overgrowth (mm)
Extrusion rate (number of implants lost)
Implant stability quotient (ISQ) measurements (ISQ units 1-100)
Measured in ISQ units (1-100)
Cosmetic result (10 point scale)
Scored using a 10-point scale and are compared to the healthy, normal contralateral situation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02438618
Brief Title
Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
Acronym
C50
Official Title
Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2, 2014 (Actual)
Primary Completion Date
December 20, 2016 (Actual)
Study Completion Date
November 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Conductive-sensorineural Hearing Loss
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minimally invasive punch technique
Arm Type
Experimental
Arm Description
New surgical technique for Ponto bone anchored hearing implants
Arm Title
Hultcrantz technique
Arm Type
Other
Arm Description
Standard surgical technique for bone anchored hearing implants
Intervention Type
Procedure
Intervention Name(s)
Surgery for Ponto bone anchored hearing aids
Primary Outcome Measure Information:
Title
Incidence of inflammation (Holgers index ≥ 2)
Time Frame
3 months post surgery
Secondary Outcome Measure Information:
Title
Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))
Time Frame
3 months post surgery
Title
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
Time Frame
3 months post surgery
Title
Loss of sensibility (Measured in mm outwards from the abutment)
Time Frame
3 months post surgery
Title
Soft tissue overgrowth (mm)
Time Frame
3 months post surgery
Title
Extrusion rate (number of implants lost)
Time Frame
3 months post surgery
Title
Implant stability quotient (ISQ) measurements (ISQ units 1-100)
Time Frame
3 months post surgery
Title
Surgical time (minutes)
Time Frame
3 months post surgery
Title
Wound healing time (time to reach healed)
Time Frame
3 months post surgery
Title
Holgers index ≥ 2 at any time point
Time Frame
24 months post surgery
Title
Presence of dehiscence after surgery (present/not present)
Time Frame
24 months post surgery
Title
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
Time Frame
24 months post surgery
Title
Loss of sensibility (Measured in mm outwards from the abutment)
Time Frame
24 months post surgery
Title
Soft tissue overgrowth (mm)
Time Frame
24 months post surgery
Title
Extrusion rate (number of implants lost)
Time Frame
24 months post surgery
Title
Implant stability quotient (ISQ) measurements (ISQ units 1-100)
Description
Measured in ISQ units (1-100)
Time Frame
24 months post surgery
Title
Cosmetic result (10 point scale)
Description
Scored using a 10-point scale and are compared to the healthy, normal contralateral situation
Time Frame
24 months post surgery
Other Pre-specified Outcome Measures:
Title
Skin position (analysed descriptively using photographs and computer software)
Description
Only at main center
Time Frame
3 months post surgery
Title
Dynamic skin motion (analysed descriptively using photographs and computer software)
Description
Only at main center
Time Frame
3 months post surgery
Title
Quality of life related questionnaires
Time Frame
24 months post surgery
Title
Correlation between cytokines and Holgers index
Time Frame
24 months post surgery
Title
Correlation IS-pro profile and Holgers index
Time Frame
24 months post surgery
Title
Development of a peri-implant dermatitis scale and compare it to the Holgers Index
Time Frame
24 months post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Stokroos, Professor
Organizational Affiliation
Maastricht University Medical Centre (MUMC+)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
33716934
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.
Results Reference
derived
PubMed Identifier
27829464
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.
Results Reference
derived
Learn more about this trial
Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
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