Single-stage bone-anchored hearing implant surgery in the pediatric population using the BI300 implant

Completed

Conditions: conductive hearing loss
hearing loss
10013995
10027584
10019190

Registration Number: NL-OMON55050

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 22

Inclusion Criteria

Test group
- 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

Test group
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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the difference in implant loss between test and<br /><br>control group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are the differences in implantstability, soft tissue<br /><br>status, time to loading and duration of surgery between groups. Total follow-up<br /><br>after surgery will be one year. </p><br>