An observational study in Survival of the Ponto Wide Implant, sponsored by University Medical Center Nijmegen. Enrolling by invitation at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by University Medical Center Nijmegen · Observational
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:
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.
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
160 studies on the registry are indexed under Deafness; 46 are open to participants now.
This study's planned enrollment of 64 is below the median of 101 across 47 observational studies indexed under Deafness.
Browse Deafness studies →University Medical Center Nijmegen is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 and previously participated in one of two already completed studies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Implant survival
The number of Ponto Wide implants that have survived 10 years after implantation.
Time frame: It will be assessed during the clinic visit between November 2024 and March 2025.
Amount of implant loss
The number of implant losses over the past 10 years based on the patient files.
Time frame: This will be examined during the period from November 2024 to March 2025
Reasons of implant loss
The reason for each implant loss.
Time frame: This will be examined during the period from November 2024 to March 2025
Amount of abutment loss
The number of abutment losses over the past 10 years based on the patient files.
Time frame: This will be examined during the period from November 2024 to March 2025
Reasons of abutment loss
The reason for each abutment loss.
Time frame: This will be examined during the period from November 2024 to March 2025
Amount of implant removal
The number of implant removal over the past 10 years based on the patient files.
Time frame: This will be examined during the period from November 2024 to March 2025
Reasons of implant removal
The reason for each implant removal.
Time frame: This will be examined during the period from November 2024 to March 2025
Amount of abutment removal
The number of abutment removals over the past 10 years based on the patient files.
Time frame: This will be examined during the period from November 2024 to March 2025
Reasons of abutment removal
The reason for each abutment removal.
Time frame: This will be examined during the period from November 2024 to March 2025
Implant stability Quotient (ISQ) measured using Osstell
ISQ (implant Stability Quotient) is a measurement scale for use with the Resonance Frequency Analysis (RFA) method of determining implant stability. The measurement is made using the Osstell Mentor equipment (Osstell, Sweden) with SmartPegs. ISQ values range from 1 to 100, the higher the score the higher the stability. The highest and lowest score obtained from perpendicular measurements will be registered.
Time frame: It will be assessed during the clinic visit between November 2024 and March 2025.
Skin complication
Skin complication rates at \>10-year follow-up are assessed using both the Holgers classification and the IPS-score. Both classification systems are standardized scales to clinically assess the skin condition around the implant.
Time frame: It will be assessed during the clinic visit between November 2024 and March 2025.
Sound processor use
Average sound processor usage (hours per day; days/week) \>10 years post-surgery.
Time frame: It will be assessed during the clinic visit between November 2024 and March 2025.
Glasgow Benefit Inventory (GBI)
The GBI questionnaire is used to evaluate the quality of life after a medical intervention. The questionnaire consists of 18 items corresponding to different aspects of the patient's well-being: quality of life, self-confidence, support, general health, and social involvement. The scoring ranges from 1 to 5, indicating that a higher score means the statement is more applicable to the patient after the intervention.
Time frame: It will be assessed during the clinic visit between November 2024 and March 2025.
International Outcome Inventory for Hearing Aids (IOI-HA)
The IOI-HA questionnaire is a seven-item tool designed to be broadly applicable in evaluating the effectiveness of hearing aid treatments. These questions provide insight into how satisfied patients are with their hearing aids. Each statement offers five possible responses on an ascending scale, indicating whether the answer is more or less applicable to the statement.
Time frame: It will be assessed during the clinic visit between November 2024 and March 2025.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Nov 2024 (actual). Primary completion is estimated for Mar 2025, 4 months after the start.
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Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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University Medical Center Nijmegen