NCT02438618
Completed
Not Applicable
Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Conductive Hearing Loss
- Sponsor
- Oticon Medical
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Incidence of inflammation (Holgers index ≥ 2)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Incidence of inflammation (Holgers index ≥ 2)
Time Frame: 3 months post surgery
Secondary Outcomes
- 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)
- Loss of sensibility (Measured in mm outwards from the abutment)(24 months post surgery)
- Implant stability quotient (ISQ) measurements (ISQ units 1-100)(24 months post surgery)
- 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)
Study Sites (1)
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