Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants

Conductive Hearing Loss Clinical Trial

— C50  

Official title:

Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438618
• Other study ID #: C50
• Status: Completed
• Phase: N/A
• Start date: December 2, 2014
• Est. completion date: November 18, 2018

Study information

• Verified date: August 2019
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 18, 2018
• Est. primary completion date: December 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Sensorineural
• Mixed Conductive-sensorineural Hearing Loss
• Unilateral Partial Deafness

Intervention

Procedure:
• Surgery for Ponto bone anchored hearing aids

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin position (analysed descriptively using photographs and computer software)	Only at main center	3 months post surgery
Other	Dynamic skin motion (analysed descriptively using photographs and computer software)	Only at main center	3 months post surgery
Other	Quality of life related questionnaires		24 months post surgery
Other	Correlation between cytokines and Holgers index		24 months post surgery
Other	Correlation IS-pro profile and Holgers index		24 months post surgery
Other	Development of a peri-implant dermatitis scale and compare it to the Holgers Index		24 months post surgery
Primary	Incidence of inflammation (Holgers index = 2)		3 months post surgery
Secondary	Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))		3 months post surgery
Secondary	Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)		3 months post surgery
Secondary	Loss of sensibility (Measured in mm outwards from the abutment)		3 months post surgery
Secondary	Soft tissue overgrowth (mm)		3 months post surgery
Secondary	Extrusion rate (number of implants lost)		3 months post surgery
Secondary	Implant stability quotient (ISQ) measurements (ISQ units 1-100)		3 months post surgery
Secondary	Surgical time (minutes)		3 months post surgery
Secondary	Wound healing time (time to reach healed)		3 months post surgery
Secondary	Holgers index = 2 at any time point		24 months post surgery
Secondary	Presence of dehiscence after surgery (present/not present)		24 months post surgery
Secondary	Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)		24 months post surgery
Secondary	Loss of sensibility (Measured in mm outwards from the abutment)		24 months post surgery
Secondary	Soft tissue overgrowth (mm)		24 months post surgery
Secondary	Extrusion rate (number of implants lost)		24 months post surgery
Secondary	Implant stability quotient (ISQ) measurements (ISQ units 1-100)	Measured in ISQ units (1-100)	24 months post surgery
Secondary	Cosmetic result (10 point scale)	Scored using a 10-point scale and are compared to the healthy, normal contralateral situation	24 months post surgery