10-year Follow-up of the Ponto Wide-implant
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Survival of the Ponto Wide Implant. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Long Term Follow-up of the Ponto Wide Implant: 10 Years of Clinical Evaluation
Обзор
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.
Подробное описание
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
Первичные конечные точки
- Implant survival [Срок оценки: It will be assessed during the clinic visit between November 2024 and March 2025.]
Вторичные конечные точки (12)
- Amount of implant loss [Срок оценки: This will be examined during the period from November 2024 to March 2025]
- Reasons of implant loss [Срок оценки: This will be examined during the period from November 2024 to March 2025]
- Amount of abutment loss [Срок оценки: This will be examined during the period from November 2024 to March 2025]
- Reasons of abutment loss [Срок оценки: This will be examined during the period from November 2024 to March 2025]
- Amount of implant removal [Срок оценки: This will be examined during the period from November 2024 to March 2025]
- Reasons of implant removal [Срок оценки: This will be examined during the period from November 2024 to March 2025]
- Amount of abutment removal [Срок оценки: This will be examined during the period from November 2024 to March 2025]
- Reasons of abutment removal [Срок оценки: This will be examined during the period from November 2024 to March 2025]
- Implant stability Quotient (ISQ) measured using Osstell [Срок оценки: It will be assessed during the clinic visit between November 2024 and March 2025.]
- Skin complication [Срок оценки: It will be assessed during the clinic visit between November 2024 and March 2025.]
- Sound processor use [Срок оценки: It will be assessed during the clinic visit between November 2024 and March 2025.]
- Glasgow Benefit Inventory (GBI) [Срок оценки: It will be assessed during the clinic visit between November 2024 and March 2025.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- No specific exclusion criteria have been set for the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Нидерланды · 1 центр
- Radboudumc — Nijmegen
Публикации
- 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
Идентификаторы
NCT: NCT06772714 · 2024-17533