Clinical trial NCT06772714: 10-year Follow-up of the Ponto Wide-implant
Official title: Long Term Follow-up of the Ponto Wide Implant: 10 Years of Clinical Evaluation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Survival of the Ponto Wide Implant
Keywords: Implant survival
Ponto Wide implant
Oticon
10 years
Deafness
Hearing loss
Hearing disorders
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
Collaborators: name: Oticon Medical
First posted: 2025-01-13
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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

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.

Primary outcomes:
measure: Implant survival
timeFrame: It will be assessed during the clinic visit between November 2024 and March 2025.
Secondary outcomes:
measure: Amount of implant loss
timeFrame: This will be examined during the period from November 2024 to March 2025
measure: Reasons of implant loss
timeFrame: This will be examined during the period from November 2024 to March 2025
measure: Amount of abutment loss
timeFrame: This will be examined during the period from November 2024 to March 2025
measure: Reasons of abutment loss
timeFrame: This will be examined during the period from November 2024 to March 2025
measure: Amount of implant removal
timeFrame: This will be examined during the period from November 2024 to March 2025
measure: Reasons of implant removal
timeFrame: This will be examined during the period from November 2024 to March 2025
measure: Amount of abutment removal
timeFrame: This will be examined during the period from November 2024 to March 2025
measure: Reasons of abutment removal
timeFrame: This will be examined during the period from November 2024 to March 2025
measure: Implant stability Quotient (ISQ) measured using Osstell
timeFrame: It will be assessed during the clinic visit between November 2024 and March 2025.
measure: Skin complication
timeFrame: It will be assessed during the clinic visit between November 2024 and March 2025.
measure: Sound processor use
timeFrame: It will be assessed during the clinic visit between November 2024 and March 2025.
measure: Glasgow Benefit Inventory (GBI)
timeFrame: It will be assessed during the clinic visit between November 2024 and March 2025.
measure: International Outcome Inventory for Hearing Aids (IOI-HA)
timeFrame: It will be assessed during the clinic visit between November 2024 and March 2025.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Emmanuel Myalnus, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.