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Single-stage Surgery Using the BHX Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04039802
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : March 16, 2020
Oticon Medical
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment
Hearing Impairment, Conductive Hearing Impaired Children Procedure: Single-stage surgery Other: Two-stage surgery

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Single-stage Bone-anchored Hearing Implant Surgery in the Pediatric Population Using the BHX Implant
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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
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.

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

Primary Outcome Measures :
  1. Implant loss [ Time Frame: 1 year ]
    The number of lost implants

Secondary Outcome Measures :
  1. Soft-tissue status according to Holgers scale [ Time Frame: 1 year ]

    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

    1. = Slight redness
    2. = Red and slightly moist tissue
    3. = Reddish and moist; sometimes granulation tissue
    4. = 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 to be an adverse skin reaction

  2. Soft-tissue status according to IPS [ Time Frame: 1 year ]

    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:

    1. 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)
    2. 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
    3. 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

  3. Time to loading [ Time Frame: through study completion, an average of 1 year ]
    Time from first surgery until loading of sound processor

  4. Duration of surgery [ Time Frame: through study completion, an average of 1 year ]
    In test group duration of single-stage surgery. In the control group duration of first and second surgery together

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04039802

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Contact: Caspers 00111111111
Contact: Hol

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Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6500hb
Contact: Coosje Caspers, MD         
Sponsors and Collaborators
Radboud University
Oticon Medical
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Principal Investigator: Hol, dr Radboud University
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Responsible Party: Radboud University Identifier: NCT04039802    
Other Study ID Numbers: 2019-5408
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Single-stage surgery
Bone conduction devices
Pediatric population
Implant loss
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms