NCT06772714

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

Long Term Follow-up of the Ponto Wide Implant: 10 Years of Clinical Evaluation

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 64 (estimated)
• Sponsor: University Medical Center Nijmegen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Survival of the Ponto Wide Implant

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2025-01-13
• Last updated: 2025-01-17

Locations

1 site across 1 country: Netherlands