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Enrolling by Invitation

NCT Number: NCT06772714

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

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.

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Key information

Conditions

Survival of the Ponto Wide Implant Deafness Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Implant survival

    Time frame: 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 outcomes

  1. Amount of implant loss

    Time frame: 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.

  2. Reasons of implant loss

    Time frame: This will be examined during the period from November 2024 to March 2025

    The reason for each implant loss.

  3. Amount of abutment loss

    Time frame: 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.

  4. Reasons of abutment loss

    Time frame: This will be examined during the period from November 2024 to March 2025

    The reason for each abutment loss.

  5. Amount of implant removal

    Time frame: 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.

  6. Reasons of implant removal

    Time frame: This will be examined during the period from November 2024 to March 2025

    The reason for each implant removal.

  7. Amount of abutment removal

    Time frame: 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.

  8. Reasons of abutment removal

    Time frame: This will be examined during the period from November 2024 to March 2025

    The reason for each abutment removal.

  9. Implant stability Quotient (ISQ) measured using Osstell

    Time frame: 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.

  10. Skin complication

    Time frame: 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.

  11. Sound processor use

    Time frame: 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.

  12. Glasgow Benefit Inventory (GBI)

    Time frame: 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.

  13. International Outcome Inventory for Hearing Aids (IOI-HA)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Nijmegen

Other

Collaborators

  • Oticon Medical

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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