Survival of the Ponto Wide Implant
Conditions
Keywords
Implant survival, Ponto Wide implant, Oticon, 10 years, Deafness, Hearing loss, Hearing disorders
Brief 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
Interventions
None listed
Sponsors
Oticon Medical
University Medical Center Nijmegen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival | It will be assessed during the clinic visit between November 2024 and March 2025. | The number of Ponto Wide implants that have survived 10 years after implantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons of implant loss | This will be examined during the period from November 2024 to March 2025 | The reason for each implant loss. |
| Amount of abutment loss | This will be examined during the period from November 2024 to March 2025 | The number of abutment losses over the past 10 years based on the patient files. |
| Reasons of abutment loss | This will be examined during the period from November 2024 to March 2025 | The reason for each abutment loss. |
| Amount of implant removal | This will be examined during the period from November 2024 to March 2025 | The number of implant removal over the past 10 years based on the patient files. |
| Reasons of implant removal | This will be examined during the period from November 2024 to March 2025 | The reason for each implant removal. |
| Amount of abutment removal | This will be examined during the period from November 2024 to March 2025 | The number of abutment removals over the past 10 years based on the patient files. |
| Amount of implant loss | This will be examined during the period from November 2024 to March 2025 | The number of implant losses over the past 10 years based on the patient files. |
| Implant stability Quotient (ISQ) measured using Osstell | It will be assessed during the clinic visit between November 2024 and March 2025. | 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. |
| Skin complication | It will be assessed during the clinic visit between November 2024 and March 2025. | 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. |
| Sound processor use | It will be assessed during the clinic visit between November 2024 and March 2025. | Average sound processor usage (hours per day; days/week) \>10 years post-surgery. |
| Glasgow Benefit Inventory (GBI) | It will be assessed during the clinic visit between November 2024 and March 2025. | 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. |
| International Outcome Inventory for Hearing Aids (IOI-HA) | It will be assessed during the clinic visit between November 2024 and March 2025. | 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. |
| Reasons of abutment removal | This will be examined during the period from November 2024 to March 2025 | The reason for each abutment removal. |
Countries
Netherlands
Outcome results
None listed