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Survival of the Ponto Wide ImplantNCT06772714

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

An observational study of Survival of the Ponto Wide Implant, run by University Medical Center Nijmegen at 1 site in Netherlands.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Survival of the Ponto Wide Implant
How many people
64 participants
Where
1 siteNetherlands
Study dates
4 Nov 2024to 31 Mar 2025
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands1 site

  • Radboudumc

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

About this study

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

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.

Read the 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

Keywords
Implant survival, Ponto Wide implant, Oticon, 10 years, Deafness, Hearing loss, Hearing disorders
Medical subject headings
Deafness, Hearing Loss, Hearing Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06772714
Study groupRoleWhat they receive
Patients with a Ponto Wide Implant for 10 yearsThe 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant survival

    The number of Ponto Wide implants that have survived 10 years after implantation.

    Measured: It will be assessed during the clinic visit between November 2024 and March 2025.

Secondary outcomes (13)

  1. Amount of implant loss

    The number of implant losses over the past 10 years based on the patient files.

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

  2. Reasons of implant loss

    The reason for each implant loss.

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

  3. Amount of abutment loss

    The number of abutment losses over the past 10 years based on the patient files.

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

  4. Reasons of abutment loss

    The reason for each abutment loss.

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

  5. Amount of implant removal

    The number of implant removal over the past 10 years based on the patient files.

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

  6. Reasons of implant removal

    The reason for each implant removal.

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

  7. Amount of abutment removal

    The number of abutment removals over the past 10 years based on the patient files.

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

  8. Reasons of abutment removal

    The reason for each abutment removal.

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

  9. 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.

    Measured: It will be assessed during the clinic visit between November 2024 and March 2025.

  10. 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.

    Measured: It will be assessed during the clinic visit between November 2024 and March 2025.

  11. Sound processor use

    Average sound processor usage (hours per day; days/week) >10 years post-surgery.

    Measured: It will be assessed during the clinic visit between November 2024 and March 2025.

  12. 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.

    Measured: It will be assessed during the clinic visit between November 2024 and March 2025.

  13. 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.

    Measured: It will be assessed during the clinic visit between November 2024 and March 2025.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start4 Nov 2024
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
64 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06772714
Sponsor's protocol ID
2024-17533
Status last verified
Jan 2025
First submitted
20 Dec 2024
Last updated
17 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kruyt IJ, Kok H, Bosman A, Nelissen RC, Mylanus EAM, Hol MKS. Three-Year Clinical and Audiological Outcomes of Percutaneous Implants for Bone Conduction Devices: Comparison Between Tissue Preservation Technique and Tissue Reduction Technique. Otol Neurotol. 2019 Mar;40(3):335-343. doi: 10.1097/MAO.0000000000002105.

    PubMed 30742596

  • den Besten CA, Bosman AJ, Nelissen RC, Mylanus EA, Hol MK. Controlled Clinical Trial on Bone-anchored Hearing Implants and a Surgical Technique With Soft-tissue Preservation. Otol Neurotol. 2016 Jun;37(5):504-12. doi: 10.1097/MAO.0000000000000994.

    PubMed 26945315

  • Nelissen RC, den Besten CA, Mylanus EA, Hol MK. Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial. Eur Arch Otorhinolaryngol. 2016 Jan;273(1):105-11. doi: 10.1007/s00405-015-3593-x. Epub 2015 Mar 20.

    PubMed 25790770

  • Vijverberg MA, Caspers CJI, Kruyt IJ, Mylanus EAM, Hol MKS. Prospective 5 year outcomes of different implant designs and surgical techniques in 68 patients with bone anchored hearing implants. Clin Otolaryngol. 2023 Jan;48(1):65-69. doi: 10.1111/coa.13974. Epub 2022 Sep 17. No abstract available.

    PubMed 36054740

  • Kruyt IJ, Nelissen RC, Mylanus EAM, Hol MKS. 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. Otol Neurotol. 2018 Jun;39(5):609-615. doi: 10.1097/MAO.0000000000001761.

    PubMed 29561377

Questions about this trial

What is this clinical trial studying?

An observational study of Survival of the Ponto Wide Implant, run by University Medical Center Nijmegen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant survival (time frame: It will be assessed during the clinic visit between November 2024 and March 2025.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06772714, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.

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