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Clinical Trials/NL-OMON48180
NL-OMON48180
Recruiting
Not Applicable

Single-stage bone-anchored hearing implant surgery in the pediatric population using the BHX implant - Single-stage surgery using the BHX implant

Radboud Universitair Medisch Centrum0 sites22 target enrollmentTBD
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Conditionsconductive hearing losshearing loss100139951002758410019190

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
conductive hearing loss
Sponsor
Radboud Universitair Medisch Centrum
Enrollment
22
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Age 4\-9 years
  • •\- Indication for percutaneous bone\-anchored hearing implant surgery with a BHX
  • •\- Insertion using the linear incision techniqueControl group (historical)
  • •\- Children who underwent implantation of a wide diameter implant using
  • •two\-stage surgery between 2012 and 2018 at the Radboudumc
  • •\- Age 4\-9 at the time of surgery

Exclusion Criteria

  • •1\. Inability to show up at all follow\-up visits
  • •2\. Patients undergoing re\-implantation
  • •3\. Diseases, syndromes or treatments known to compromise the bone quality at
  • •the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
  • •4\. Insufficient bone thickness \<\=1mm, since conversion to two\-stage surgery will
  • •be advocatedControl group
  • •1\. Follow\-up duration less than 1 year.
  • •2\. Diseases, syndromes or treatments known to compromise the bone quality at
  • •the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus (at moment
  • •of implantation)

Outcomes

Primary Outcomes

Not specified

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