10-year Follow-up of the Ponto Wide-implant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Survival of the Ponto Wide Implant. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long Term Follow-up of the Ponto Wide Implant: 10 Years of Clinical Evaluation
Overview
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
Primary outcome measures
- Implant survival [Time frame: It will be assessed during the clinic visit between November 2024 and March 2025.]
Secondary outcome measures (12)
- Amount of implant loss [Time frame: This will be examined during the period from November 2024 to March 2025]
- Reasons of implant loss [Time frame: This will be examined during the period from November 2024 to March 2025]
- Amount of abutment loss [Time frame: This will be examined during the period from November 2024 to March 2025]
- Reasons of abutment loss [Time frame: This will be examined during the period from November 2024 to March 2025]
- Amount of implant removal [Time frame: This will be examined during the period from November 2024 to March 2025]
- Reasons of implant removal [Time frame: This will be examined during the period from November 2024 to March 2025]
- Amount of abutment removal [Time frame: This will be examined during the period from November 2024 to March 2025]
- Reasons of abutment removal [Time frame: This will be examined during the period from November 2024 to March 2025]
- Implant stability Quotient (ISQ) measured using Osstell [Time frame: It will be assessed during the clinic visit between November 2024 and March 2025.]
- Skin complication [Time frame: It will be assessed during the clinic visit between November 2024 and March 2025.]
- Sound processor use [Time frame: It will be assessed during the clinic visit between November 2024 and March 2025.]
- Glasgow Benefit Inventory (GBI) [Time frame: It will be assessed during the clinic visit between November 2024 and March 2025.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Radboudumc — Nijmegen
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 29561377
Identifiers
NCT: NCT06772714 · 2024-17533