Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants

Not Applicable

Completed

• Conditions: Conductive Hearing Loss; Unilateral Partial Deafness; Mixed Conductive-sensorineural Hearing Loss
• Interventions: Procedure: Surgery for Ponto bone anchored hearing aids

• 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

Arm && Interventions

Group	Intervention	Description
Hultcrantz technique	Surgery for Ponto bone anchored hearing aids	Standard surgical technique for bone anchored hearing implants
Minimally invasive punch technique	Surgery for Ponto bone anchored hearing aids	New surgical technique for Ponto bone anchored hearing implants

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
Loss of sensibility (Measured in mm outwards from the abutment)	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

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands