To compare implant loss between single-stage BAHI surgery (test group) and two-stage BAHI surgery (control group) in children. Furthermore, to compare soft tissue status, time to loading and duration of surgery between groups.
ID
Source
Brief title
Condition
- Ear and labyrinthine disorders congenital
- Middle ear disorders (excl congenital)
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in implant loss between test and
control group.
Secondary outcome
Secondary study parameters are the differences in implantstability, soft tissue
status, time to loading and duration of surgery between groups. Total follow-up
after surgery will be one year.
Background summary
Over the last few decades, the classical two-stage surgical procedure has been
modified in adults into a single-stage procedure. This approach has several
advantages since it avoids a second surgical procedure. The single-stage
approach is proven to be safe and feasible in adults and is nowadays referred
to as the standard surgical technique in adults. A few centers already
implemented this technique for children and show a low rate of early
complications and fixture loss due to osseointegration failure, suggesting that
single-stage surgery in children might be feasible. Despite these favorable
outcomes and advantages of the single-stage surgery, most ENT-surgeons still
perform two-stage surgery when inserting BAHI in the pediatric population. This
is due to the limited number of prospective comparative studies and the fear
for implant loss in a vulnerable population. In previous studies, reported
implant loss rates were twice as high in children compared to adults. However,
after the introduction of the wide diameter implants, short- and long-term
implant loss rates declined in adults. Therefore, we believe it is safe to
initiate single-stage surgery in the pediatric population. Reliable evidence
which proves the safety of the single-stage procedure should be provided in
order to implement this surgery as the regular care in children.
Study objective
To compare implant loss between single-stage BAHI surgery (test group) and
two-stage BAHI surgery (control group) in children. Furthermore, to compare
soft tissue status, time to loading and duration of surgery between groups.
Study design
Prospective comparative study with historical control group.
Intervention
In the test group, BAHI insertion will be performed using single-stage surgery.
Patients in the control group already underwent BAHI insertion using two-stage
surgery.
Study burden and risks
The number of site visits does not differ from the standard of care. In
comparison to two-stage surgery, single-stage surgery avoids a second general
anaesthesia, reduces operation time and allows for earlier hearing
rehabilitation. So far, only a few centers already implemented the single-stage
surgery in children and showed a low rate of early complications and fixture
loss due to osseointegration failure. However, most studies evaluating
single-stage surgery in children are retrospective studies with a small sample
size and vary in surgical technique, age range and follow-up duration. There is
a minimal risk that single-stage surgery will lead to an increase in implant
loss due to failure of osseointegration, resulting in the need for a second
surgery. However, this makes no difference since a second surgery would also be
performed in case of the standard two-stage procedure.
Philips van Leydenlaan 15
Nijmegen 6525EX
NL
Philips van Leydenlaan 15
Nijmegen 6525EX
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04038216 |
| CCMO | NL69861.091.19 |