NCT04039802

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2023

Completed
Last Updated

November 18, 2025

Status Verified

September 1, 2023

Enrollment Period

3.9 years

First QC Date

April 23, 2019

Last Update Submit

November 14, 2025

Conditions

Hearing Impairment, ConductiveHearing Impaired Children

Keywords

Single-stage surgeryBone conduction devicesPediatric populationImplant loss

Outcome Measures

Primary Outcomes (1)

  • Implant loss

    The number of lost implants

    1 year

Secondary Outcomes (4)

  • Soft-tissue status according to Holgers scale

    1 year

  • Soft-tissue status according to IPS

    1 year

  • Time to loading

    through study completion, an average of 1 year

  • Duration of surgery

    through study completion, an average of 1 year

Study Arms (2)

Test

In the test group, patients will be scheduled for bone-anchored hearing implant surgery using the single-stage procedure. The implant and abutment will be placed in one surgery

Procedure: Single-stage surgery

Control

Historical control group, these patients already underwent BAHI insertion using two-stage surgery. The implant and abutment were inserted in two different procedures

Other: Two-stage surgery

Interventions

Single-stage surgeryPROCEDURE

In the test group, patients will be scheduled for bone-anchored hearing implant surgery using the single-stage procedure. The implant and abutment will be placed in one surgery.

Test
Two-stage surgeryOTHER

Two-stage surgery has already been performed, data will therefore be retrospectively collected

Control

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients 4 to 9 years old who are planned for treatment with a BAHI (BI300 implant) are considered candidates for the study. They will be approached for participation in the trial after they have chosen a Cochlear sound processor after thorough clinical and audiological testing and counseling. These patients are selected from a tertiary referral center

You may qualify if:

  • Age 4-9 years
  • Indication for percutaneous bone-anchored hearing implant surgery with a BI300 implant
  • Insertion using the linear incision technique
  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500hb, Netherlands

Location

Related Publications (6)

  • 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.

    PMID: 23010336BACKGROUND

  • 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.

    PMID: 18439475BACKGROUND

  • 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.

    PMID: 19473711BACKGROUND

  • Marsella P, Scorpecci A, D'Eredita 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.

    PMID: 22643446BACKGROUND

  • 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. doi: 10.1177/000348940811701103.

    PMID: 19102125BACKGROUND

  • 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.

    PMID: 19960162BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hol, dr

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2019

First Posted

July 31, 2019

Study Start

September 1, 2019

Primary Completion

July 24, 2023

Study Completion

July 24, 2023

Last Updated

November 18, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)