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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-24

Study Completion Date

2020-09-21

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control implant loaded at 6 weeks post-surgery

The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment.

Group Type ACTIVE_COMPARATOR

Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment

Intervention Type DEVICE

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. In addition to the difference in abutment shape and the wider diameter, the test implant incorporates small-sized threads at the implant neck and the moderately rough TiOblast™ (Dentsply, Mölndal, Sweden) surface on the intraosseous part of the implant6-8.

Test implant loaded at 3 weeks post-surgery

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.

Group Type EXPERIMENTAL

Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment

Intervention Type DEVICE

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. In addition to the difference in abutment shape and the wider diameter, the test implant incorporates small-sized threads at the implant neck and the moderately rough TiOblast™ (Dentsply, Mölndal, Sweden) surface on the intraosseous part of the implant6-8.

Early loading

Intervention Type PROCEDURE

Loading the implant at 3 weeks after implantation (instead of 6 weeks after implantation)

Interventions

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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.

Intervention Type DEVICE

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. In addition to the difference in abutment shape and the wider diameter, the test implant incorporates small-sized threads at the implant neck and the moderately rough TiOblast™ (Dentsply, Mölndal, Sweden) surface on the intraosseous part of the implant6-8.

Intervention Type DEVICE