Status:
TERMINATED
Single-stage Surgery Using the BI300 Implant
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Cochlear Bone Anchored Solutions
Conditions:
Hearing Impaired Children
Hearing Impairment, Conductive
Eligibility:
All Genders
4-9 years
Brief Summary
Over the last few decades, the classical two-stage surgical procedure for inserting bone-anchored hearing implants (BAHIs) has been modified in adults into a single-stage procedure. This approach has ...
Detailed Description
General description: A prospective comparative study with historical control group will be performed.The test group will consist of 22 children aged 4-9 years old who are found to be suitable candida...
Eligibility Criteria
Inclusion
- 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 technique
- Inclusion criteria Control group:
- 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 surgery
- Exclusion Criteria Test group
- Inability to show up at all follow-up visits
- Patients undergoing re-implantation
- Diseases, syndromes or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
- Insufficient bone thickness ≤1mm, since conversion to two-stage surgery will be advocated
- Exclusion Criteria Control group
- Follow-up duration less than 1 year.
- Diseases, syndromes or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus (at moment of implantation)
Exclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 25 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04038216
Start Date
September 1 2019
End Date
March 25 2025
Last Update
November 18 2025
Active Locations (1)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500hb