Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

Completed

• Conditions: Mixed Hearing Loss; Single Sided Deafness; Conductive Hearing Loss

• Registration Number: NCT02064478
• Lead Sponsor: Oticon Medical

Brief Summary

A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness.

With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study.

The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Primary Completion: 2015-04
• Study Completion: 2017-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 18 years or older
• Patient indicated for an ear level bone anchored sound processor
• Bone thickness at the implant site of at least 4 mm

Exclusion Criteria

• Inability to participate in follow-up
• Psychiatric disease in the medical history
• Mental disability
• Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
• Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
• Patients with natural skin height of >10 mm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numbness around implant, specifically mean Total sensibility	36 months after surgery

Secondary Outcome Measures

Name	Time	Method
Time to implant loss	0-36 months
Length of surgery	At surgery
Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient	0-36 months
Skin condition according to Holgers	3 years after surgery
Proportion of patients with complete wound healing at first surgical visit	7 days
Abbreviated profile of hearing aid benefit (APHAB) scores	36 months
Bone conduction (BC) audiometric threshold	6 months	Measured with B-71
Mild/Adverse skin reaction	0-36 months	Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period
Postoperative complications	7 days to 36 months	Including; * Bleeding or hematoma; * Flap necrosis; * Wound dehiscence; * Other (description)
Glasgow Benefit Inventory (GBI) scores	12 months
Glasgow Health Status Inventory (GHSI) scores	36 months
Mean hours of use of the sound processor	0-36 months
Bone conduction (BC) in-situ audiometric thresholds	6 months
Mean total sensibility around implant	36 months
Implant stability quotient (ISQ)	36 months post surgery
Patient and Observer scar assessment score	36 months

Trial Locations

Locations (1)

Radboud University Medical Centre; 🇳🇱 Nijmegen, Netherlands