10-year Follow-up of the Ponto Wide-implant

University Medical Center Nijmegen

Status: Invitation-only

Conditions: Survival of the Ponto Wide Implant

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06772714

2024-17533

Details and patient eligibility

About

The goal of this single center, prospective study is to investigate the survival of the Ponto Wide Implant at least 10 years after implantation.

Secondary objectives are:

1. To determine the amount and causes of implant loss and implant and/or abutment removal.
2. To establish the stability of the implant.
3. To assess skin complications.
4. To investigate daily usage and the number of hours of use of the sound processor.
5. To determine the quality of life.

During a check-up of the implant at the outpatient clinic, the skin around the implant will be assessed, the stability of the implant will be measured, and the patient will be asked to complete two questionnaires.

Full description

Patients who participated in the previous studies concerning the Ponto Wide implant from Oticon (3 years after implantation) will be approached. If consent is given, they will be added to the database of the already completed studies, and new data will be stored in the same database. The patients were already pseudonymized in the previous studies, and the database is secured with a code that is only accessible to individuals directly involved in the research

Enrollment: 64 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Implantation with Ponto Wide implant (diameter 4.5 mm, length 4.0 mm)
• Ten or more years of post-operative follow-up.
• Valid informed consent

Exclusion criteria

• No specific exclusion criteria have been set for the study.

Trial design

64 participants in 1 patient group

Patients with a Ponto Wide Implant for 10 years

Description:

The study population consists of patients who received a Ponto Wide implant (4.5 mm diameter, 4.0 mm length) at least 10 years ago. Only patients who participated in one of the two previous completed studies (Long-term stability and survival rates of a novel Oticon Medical bone conduction device implant, Three-year Outcomes of a Randomized Controlled Trial Comparing a 4.5-mm-Wide to a 3.75-mm-Wide Titanium Implant for Bone Conduction Hearing) will be included