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

Radboud University Medical Center

Status: Completed

Conditions: Hearing Loss

Treatments: Procedure: Early loading; Device: Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment; Device: Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05058066

CAG5173/CBAS5562 10y

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 3 patient groups

Control implant loaded at 6 weeks post-surgery

Active Comparator group

Description:

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

Treatment:

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

Test implant loaded at 6 weeks post-surgery

Experimental group

Description:

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.

Treatment:

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

Test implant loaded at 3 weeks post-surgery

Experimental group

Description:

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.

Treatment:

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

Procedure: Early loading