Immediate Loading of Bone Anchored Hearing Devices
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Baha sound processor BA400
Sponsored by
About this trial
This is an interventional supportive care trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Patients eligible for receiving the Baha system.
Exclusion Criteria:
- Adult patients, i.e. ≥18 years
- Eligible for the Baha system
- Bone thickness at the implant site of at least 4 mm
- No known disease or treatment that compromises / will compromise the bone quality at the implant site
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immediate loading group
2-week loading group
Arm Description
Visit 1 Implant surgery + Device loading Baseline Visit 2 Followup examination 2 weeks (2/+ 5 days) Visit 3 Followup examination 3 months (± 1 week) Visit 4 Followup examination 6 months (± 1 week) Visit 5 Followup examination 12 months (± 1 month)
Visit 1 Implant surgery Baseline Visit 2 Device loading 2 weeks (2/+5 days) Visit 3 Followup examination 3 months (± 1 week) Visit 4 Followup examination 6 months (± 1 week) Visit 5 Followup examination 12 months (± 1 month)
Outcomes
Primary Outcome Measures
Compare device stability and rate of successful implantation
Measuring device stability and rate of successful implantation for patients fitted with the Baha BA400 immediately on the day of surgery and at fitting 2 weeks post operatively. A successful implant is an implant that osseointegrates and is stable over time when supporting the load of the Baha sound processor.
Secondary Outcome Measures
Measure the stability, as determined by Implant Stability Quotient (ISQ) values, of Baha implants placed immediately and at 23 weeks post operatively.
Record implant survival over time.
Monitor the status of the periimplant soft tissue using the classification proposed by Holgers' et al.
Full Information
NCT ID
NCT04611698
First Posted
October 22, 2020
Last Updated
April 24, 2023
Sponsor
Manchester University NHS Foundation Trust
Collaborators
Northern Care Alliance NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04611698
Brief Title
Immediate Loading of Bone Anchored Hearing Devices
Official Title
Immediate Loading of Bone Anchored Hearing Devices
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
Collaborators
Northern Care Alliance NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Bone anchored hearing aids provide a hearing solution for patients that are unable to wear traditional air conduction hearing aid solutions. The technology of the devices has developed significantly over the last 510 years and patients are gaining access to their sound processor at a much earlier stage than when first brought onto the market. Despite this the investigators feel there is still room to develop this and with the new abutments with specialised hydroxyapatite coating it is hoped that patients can be loaded with their sound processor in the day of surgery. This study will compare abutment stability between two groups of patients. Those loaded immediately with their sound processor and those loaded traditionally at 2 weeks post operatively.
At routine followup appointments patients will have the stability of their abutment checked and the investigators will compare to see if loading earlier had any detrimental effects on osteointegration and the stability of the abutment.
Based on the favourable outcomes and high stability record for the BA400 it is anticipated that the time to processor fitting may be further reduced, provided favourable bone conditions at the implant site and provided satisfactory soft tissue status at the time of loading. It is hypothesised that loading immediately at the time of surgery is possible with comparable short and long term outcomes when compared to standard loading at 2 weeks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate loading group
Arm Type
Experimental
Arm Description
Visit 1 Implant surgery + Device loading Baseline Visit 2 Followup examination 2 weeks (2/+ 5 days) Visit 3 Followup examination 3 months (± 1 week) Visit 4 Followup examination 6 months (± 1 week) Visit 5 Followup examination 12 months (± 1 month)
Arm Title
2-week loading group
Arm Type
Experimental
Arm Description
Visit 1 Implant surgery Baseline Visit 2 Device loading 2 weeks (2/+5 days) Visit 3 Followup examination 3 months (± 1 week) Visit 4 Followup examination 6 months (± 1 week) Visit 5 Followup examination 12 months (± 1 month)
Intervention Type
Device
Intervention Name(s)
Baha sound processor BA400
Intervention Description
Baha sound processor BA400 is a cochlear implant designed specifically for soft tissue preservation.
Primary Outcome Measure Information:
Title
Compare device stability and rate of successful implantation
Description
Measuring device stability and rate of successful implantation for patients fitted with the Baha BA400 immediately on the day of surgery and at fitting 2 weeks post operatively. A successful implant is an implant that osseointegrates and is stable over time when supporting the load of the Baha sound processor.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Measure the stability, as determined by Implant Stability Quotient (ISQ) values, of Baha implants placed immediately and at 23 weeks post operatively.
Time Frame
23 weeks
Title
Record implant survival over time.
Time Frame
12 months
Title
Monitor the status of the periimplant soft tissue using the classification proposed by Holgers' et al.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients eligible for receiving the Baha system.
Exclusion Criteria:
Adult patients, i.e. ≥18 years
Eligible for the Baha system
Bone thickness at the implant site of at least 4 mm
No known disease or treatment that compromises / will compromise the bone quality at the implant site
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immediate Loading of Bone Anchored Hearing Devices
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