NL-OMON55050
Completed
Not Applicable
Single-stage bone-anchored hearing implant surgery in the pediatric population using the BI300 implant - Single-stage surgery using the BI300 implant
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 22
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age 4\-9 years
- •\- Indication for percutaneous bone\-anchored hearing implant surgery with a
- •BI300 implant
- •\- 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
- •\- Linear incision technique was used during surgeryideWhe
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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