Hearing Impaired Children Clinical Trial
Official title:
Single-stage Bone-anchored Hearing Implant Surgery in the Pediatric Population Using the BI300 Implant
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 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. Despite favorable outcomes and advantages of the single-stage surgery, most Ear Nose Throat (ENT)-surgeons still perform two-stage surgery when inserting BAHI in the pediatric population. Therefore, the aim of this study is to compare implant loss between single-stage BAHI surgery and two-stage BAHI surgery in children aged 4 to 9 years.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 9 Years |
Eligibility |
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 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 advocated Exclusion Criteria Control 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) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboudumc | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University | Cochlear Bone Anchored Solutions |
Netherlands,
Ali S, Hadoura L, Carmichael A, Geddes NK. Bone-anchored hearing aid A single-stage procedure in children. Int J Pediatr Otorhinolaryngol. 2009 Aug;73(8):1076-9. doi: 10.1016/j.ijporl.2009.03.028. Epub 2009 May 26. — View Citation
de Wolf MJ, Hol MK, Huygen PL, Mylanus EA, Cremers CW. Nijmegen results with application of a bone-anchored hearing aid in children: simplified surgical technique. Ann Otol Rhinol Laryngol. 2008 Nov;117(11):805-14. — View Citation
Kohan D, Morris LG, Romo T 3rd. Single-stage BAHA implantation in adults and children: is it safe? Otolaryngol Head Neck Surg. 2008 May;138(5):662-6. doi: 10.1016/j.otohns.2007.12.019. — View Citation
Marsella P, Scorpecci A, D'Eredità R, Della Volpe A, Malerba P. Stability of osseointegrated bone conduction systems in children: a pilot study. Otol Neurotol. 2012 Jul;33(5):797-803. doi: 10.1097/MAO.0b013e318255dd73. — View Citation
Mazita A, Fazlina WH, Abdullah A, Goh BS, Saim L. Hearing rehabilitation in congenital canal atresia. Singapore Med J. 2009 Nov;50(11):1072-6. — View Citation
Saliba I, Froehlich P, Bouhabel S. One-stage vs. two-stage BAHA implantation in a pediatric population. Int J Pediatr Otorhinolaryngol. 2012 Dec;76(12):1814-8. doi: 10.1016/j.ijporl.2012.09.007. Epub 2012 Sep 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implant loss | The number of lost implants | 1 year | |
Secondary | Soft-tissue status according to Holgers scale | The Holgers scale is a worldwide used soft tissue assessment scale for percutaneous implants for BCDs. The degree of soft tissue reactions is classified as follows27: 0 = No irritation = Slight redness = Red and slightly moist tissue = Reddish and moist; sometimes granulation tissue = Removal of skin-penetrating implant necessary due to infection R = Removal of implant for reasons not related to skin problems Holgers score of 2 or higher is considered an adverse skin reaction |
1 year | |
Secondary | Time to loading | Time from first surgery until loading of sound processor | through study completion, an average of 1 year | |
Secondary | Duration of surgery | In test group duration of single-stage surgery. In control group duration of first and second surgery together | through study completion, an average of 1 year | |
Secondary | Soft-tissue status according to IPS scale | The IPS scale is a relatively new consistent, uniform, and easy assessment scale for both percutaneous and transcutaneous implants for BCDs.28 For percutaneous implants, the IPS-scale comprising three parts: inflammation, pain, and skin height, with higher scores reflecting more severe complication. It assesses the following characteristics: Inflammation: Skin Integrity (intact = 0 / not intact = 1) Erythema (none = 0 / present = 1) Edema (none = 0 / present = 1) Granulation tissue formation (none = 0/ present = 1) Pain: None = 0 Present, but no increase during manipulation abutment AND <6 wks present = 1 Present, and increase during manipulation abutment AND/OR >6 wks present = 2 Skin height: Normal = 0 Increased, but able to couple sound processor = 1 Above rim abutment/unable to couple sound processor =2 An IPS score equal to or higher than I1P1S0/I2P0S0/I0P2S0/I0P0S2 is considered an adverse event |
1 year |
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