Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
NCT ID: NCT01738490
Last Updated: 2017-11-27
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
59 participants
INTERVENTIONAL
2012-06-30
2016-12-31
Brief Summary
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More specifically the primary objective of this clinical study is to test the hypothesis
* The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant.
And the secondary objective is to
* Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Wide diameter implant
Bone anchored hearing implant For the wide diameter arm (test group), the Ponto wide implant (diameter 4,5mm, length 4mm) and abutment 6mm developed by Oticon Medical AB (Gothenburg, Sweden) will be installed.
Bone anchored hearing implant
Control group
Bone anchored hearing implant For the control group, the previous generation Ponto implant (diameter 3,75mm, length 4mm) and 6mm abutment (Oticon Medical AB, Gothenburg, Sweden) will be installed.
Bone anchored hearing implant
Interventions
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Bone anchored hearing implant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient indicated for an ear level bone anchored sound processor
* Bone thickness at the implant site of at least 4 mm
Exclusion Criteria
* Inability to participate in follow-up
* Psychiatric disease in the medical history
* Mental disability
* Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
18 Years
ALL
No
Sponsors
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Oticon Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Myrthe KS Hol, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center St Radboud, Nijmegen, The Netherlands
Locations
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University Medical Center St Radboud
Nijmegen, , Netherlands
Countries
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References
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Nelissen RC, den Besten CA, Mylanus EA, Hol MK. Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial. Eur Arch Otorhinolaryngol. 2016 Jan;273(1):105-11. doi: 10.1007/s00405-015-3593-x. Epub 2015 Mar 20.
Other Identifiers
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C33
Identifier Type: -
Identifier Source: org_study_id