Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants

Not Applicable

Completed

• Conditions: Conductive Hearing Loss; Unilateral Partial Deafness; Mixed Conductive-sensorineural Hearing Loss

• Registration Number: NCT02438618
• Lead Sponsor: Oticon Medical

Brief Summary

The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-02
• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Primary Completion: 2016-12-20
• Study Completion: 2018-11-18
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Adult patient, i.e. ≥ 18 years of age
• Eligible for the Ponto system

Exclusion Criteria

• Known history of immunosuppressive disease
• Use of systemic immunosuppressive medication
• Receiving bilateral bone anchored hearing system
• Relevant dermatological diseases as judged by the investigator
• Not being able to finish the study, for example because of failure to complete the questionnaires
• Participating in another study with medical aids or medication
• When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of inflammation (Holgers index ≥ 2)	3 months post surgery

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)	24 months post surgery
Soft tissue overgrowth (mm)	24 months post surgery
Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))	3 months post surgery
Presence of dehiscence after surgery (present/not present)	24 months post surgery
Cosmetic result (10 point scale)	24 months post surgery	Scored using a 10-point scale and are compared to the healthy, normal contralateral situation
Implant stability quotient (ISQ) measurements (ISQ units 1-100)	24 months post surgery	Measured in ISQ units (1-100)
Holgers index ≥ 2 at any time point	24 months post surgery
Extrusion rate (number of implants lost)	24 months post surgery
Surgical time (minutes)	3 months post surgery
Wound healing time (time to reach healed)	3 months post surgery
Loss of sensibility (Measured in mm outwards from the abutment)	24 months post surgery

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands