Clinical trial NCT05058066: 10-year Follow-up of a Wide Diameter Bone Anchored Hearing Implant
Official title: Long-term Follow-up of a Wide Diameter Bone Anchored Hearing Implant: the 10-year Experience on Stability, Survival and Tolerability of the BIA300®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Cochlear Bone Anchored Solutions
First posted: 2021-09-27
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: implant stability
timeFrame: 10 years after implantation
Secondary outcomes:
measure: implant survival
timeFrame: 10 years after implantation
measure: soft tissue reaction
timeFrame: 10 years after implantation
measure: device use
timeFrame: 10 years after surgery
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: