Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
NCT ID: NCT02438618
Last Updated: 2019-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2014-12-02
2018-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Minimally invasive punch technique
New surgical technique for Ponto bone anchored hearing implants
Surgery for Ponto bone anchored hearing aids
Hultcrantz technique
Standard surgical technique for bone anchored hearing implants
Surgery for Ponto bone anchored hearing aids
Interventions
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Surgery for Ponto bone anchored hearing aids
Eligibility Criteria
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Inclusion Criteria
* Eligible for the Ponto system
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Oticon Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Stokroos, Professor
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre (MUMC+)
Locations
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Maastricht University Medical Centre
Maastricht, , Netherlands
Countries
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References
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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.
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.
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.
Other Identifiers
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C50
Identifier Type: -
Identifier Source: org_study_id
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