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Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT05058066
Study type Interventional
Source Radboud University
Status Completed
Phase N/A
Start date June 24, 2019
Completion date September 21, 2020

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