10-year Follow-up of a Wide Diameter Bone Anchored Hearing Implant

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment; Device: Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment; Procedure: Early loading

• Registration Number: NCT05058066
• Lead Sponsor: Radboud University Medical Center

Brief Summary

A single centre, open, comparative, parallel group, prospective clinical investigation with a single 10 year follow up visit.

Detailed Description

This study is a continuation of two previous conducted trials:

1. Stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation new BIA300 (test) implant vs previous generation (control) implant:

1. CAG5173: 6-month(1) and 3-year(2) data.

2. CBAS5562: 5-year data(3).

2. 3 weeks loading: stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation 3 week loading vs 6+ week loading (= same group as control group trial 1). 6- month(4) and 3-year(5) data.

In this study the (5-year data for trial 2 and) 10-year data regarding stability, survival and soft tissue tolerability from the above mentioned trials will be evaluated and compared. The previous trials were multicentre, but the current study will be single-centred and therefore only include the participants of the Radboud site. Data will be collected at a visit at (5 years, for trial 2 and) 10 years (+/- 6 months) after implantation.

Up to now, no RCT of these implants (with the loading of 3 weeks after implantation) has assessed stability, survival and tolerability over a 10-year follow-up period.

Study Timeline

• Study Start: 2019-06-24
• Primary Completion: 2020-09-21
• Study Completion: 2020-09-21
• Status Verified: 2021-09
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-16
• Last Update Submitted: 2021-09-16
• Study First Posted: 2021-09-27
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• To be included in the original trials, patients had to be at least 18 years old.

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Exclusion Criteria

• Exclusion criteria were an inability to follow investigational procedures, any factor at the discretion of the investigator that was considered to contraindicate participation, and any disease or treatment known to compromise the bone quality at the implant site. For patients who had lost or removed the implant, the time to implant loss was recorded. Patients who could not attend the 5 or 10 year follow-up visit for other reasons were included in the implant survival analysis as well; the last available information regarding implant survival was obtained verbally from the patient, from medical records, or from information captured from the original investigations. Furthermore, patients were excluded if they had a bone thickness less than 4 mm at the implant site during implantation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test implant loaded at 3 weeks post-surgery	Early loading	The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment.
Control implant loaded at 6 weeks post-surgery	Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment	The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment.
Test implant loaded at 6 weeks post-surgery	Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment	The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment.
Test implant loaded at 3 weeks post-surgery	Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment	The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment.

Primary Outcome Measures

Name	Time	Method
implant stability	10 years after implantation	Implant Stability Quotiënt (ISQ) will be measured at the 10y-visit. The resonance frequency analysis renders an ISQ value ranging from 1 to 100. Measurements shall be performed at the abutment level, as is done in the previous investigations. The highest and lowest ISQ value out of two perpendicular measurements shall be recorded as ISQ High and ISQ low. The measurement should preferably be done by the same Osstell instrument (Osstell, Gothenburg, Sweden) that was used in the previous completed study. SmartPeg Type 43 and 55 shall be used during the measurement (Osstell, Gothenburg, Sweden). The procedures for obtaining ISQ values is described in the manufacturer's instruction that will be handed out to the investigators.

Secondary Outcome Measures

Name	Time	Method
soft tissue reaction	10 years after implantation	Soft tissue reactions will be measured using the Holgers' classification \& IPS-score.; The Holgers' classification is designed to capture signs and symptoms of inflammation or infection at the site of implantation (scale 0-4).; The IPS-score is a complete standardized assessment scale for skin complications for both percutaneous and transcutaneous implants for bone conduction devices (BCDs) with a proposed treatment advice based on the outcome. The IPS score has three subscales: inflammation (0-4); pain (0-2), and skin height (0-2).
implant survival	10 years after implantation	All patients will be asked if they have experienced any implant osseointegration problems. The time from implantation until implant loss or removal will be noted. In case of implant removal, reason for removal shall be recorded.
device use	10 years after surgery	To evaluate the long-term device use of a Baha®.

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands