Oticon Medical Ponto Wide Implant in Children
Research type
Research Study
Full title
Oticon Medical Ponto Wide Implant in Children
IRAS ID
145812
Contact name
Ann- Louise McDermott
Contact email
Sponsor organisation
Oticon Medical AB
Clinicaltrials.gov Identifier
C47, Clinical Investigation Plan Number
Research summary
The long-term success of bone anchored hearing systems rate is high with a low rate of major complications2. However, complication rates in pediatric patients are higher compared to that in adult patients5,6,7. The new wide Ponto implant family shows promising improvements in implant stability in technical measurements and ongoing clinical studies in adult patients3,10,11,12.
This clinical prospective study will investigate the clinical outcomes of the Ponto wide implant in children. The increased stability that this implant potentially offers might prove even more important in children, since implant losses occur more frequently in this population.It is standard practice to operate children aged 10 years or younger with a two-stage procedure to allow for optimal osseointegration. In the first stage the implant is inserted into the skull. When the implant is believed to have osseointegrated (typically 3 months after first stage surgery), the second stage surgery is performed. An abutment is placed at this stage5,6,7. However, in children with a relatively thick bone, the surgery is done in one stage in the same way it is done in adults. Age and bone thickness are typically used as the criteria to determine if the surgery will be done in one stage or two stages. Implant stability can also be as a factor. Implant stability can be measured through Resonant Frequency Analysis (RFA)8.
The present study will document the initial stability of the implant and investigate how stability measurements differ between children who undergo single stage surgeries and those who undergo two stage surgeries. The data gathered from the study will allow us to gain valuable insight into stability of the new wide implant in children, and to explore the use of implant stability as a criterion to determine if the surgery should be done in one stage or in two stages. Further, data on the development of stability over time will allow us to estimate the time needed for osseointegration in children, guiding the interval between the first and second stage in a two-stage procedure.
The primary outcome measure is implant stability (ISQ, implant stability quotient) which will be measured using implant stability quotient (ISQ) scale at the implant and abutment levels using Ostell ISQ and SmartPegs8. Details on this measurement are provided in appendix A.Skin reactions at the time of surgery and at the follow up visits will be evaluated using a Holgers Scale9. A description of the scale is provided in appendix B.
Pain and numbness will be investigated using a visual analog scale (VAS)
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1054
Date of REC Opinion
29 Aug 2014
REC opinion
Further Information Favourable Opinion