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

NCT06772714 | Enrolling By Invitation

• 1 other identifier: 2024-17533
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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. 1.To determine the amount and causes of implant loss and implant and/or abutment removal.
2. 2.To establish the stability of the implant.
3. 3.To assess skin complications.
4. 4.To investigate daily usage and the number of hours of use of the sound processor.
5. 5.To determine the quality of life.

Conditions

Survival of the Ponto Wide Implant

Keywords

Implant survival; Ponto Wide implant; Oticon; 10 years; Deafness; Hearing loss; Hearing disorders

Outcome Measures

Primary Outcomes (1)

• Implant survival

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

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

Secondary Outcomes (13)

• Amount of implant loss

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

• Reasons of implant loss

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

• Amount of abutment loss

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

• Reasons of abutment loss

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

• Amount of implant removal

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

Study Arms (1)

Patients with a Ponto Wide Implant for 10 years

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. 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Nijmegen: lead
• Oticon Medical: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Deafness; Hearing Loss; Hearing Disorders

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel Myalnus, Prof. dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 13, 2025
• Study Start: November 4, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)