Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique

Phase 3

Recruiting

Conditions: deafness
hearing loss
10019243

Registration Number: NL-OMON45173

Lead Sponsor: COCHLEAR BONE ANCHORED SOLUTIONS AB

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 63

Inclusion Criteria

* Adult patient, i.e. * 18 years of age
* Eligible for the Baha system
* Signed informed consent

Exclusion Criteria

* Patient scheduled for simultaneously bilateral implant surgery
* Uncontrolled diabetes as judged by the investigator
* Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
* Unable to follow the cleaning instruction
* Unable to follow investigational procedures, e.g. to complete quality of life scales
* Participation in another investigation with pharmaceuticals and/or device
* Condition that may have an impact on the outcome of the investigation as judged by the investigator
* Suitable implant position for the 4 mm implant not found during surgery due to insufficient bone quality and/or bone thickness

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The first primary endpoint, a combined endpoint of infection/inflammation,<br /><br>overgrowth, pain and numbness,will be evaluated by a function of the Holgers<br /><br>Index, the Soft tissue thickening/over-growth scale, POSAS pain scale, question<br /><br>regarding pain in scar/neuropathic pain and Numbness scale.<br /><br><br /><br>The second primary variable, the costs of the surgical procedure, complications<br /><br>and number of extra wound dressings sessions will be evaluated by surgical<br /><br>time, Holgers Index and the number of extra dressing sessions. The costs will<br /><br>be estimated and evaluated in local currency.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Wound healing<br /><br>* Numbness<br /><br>* Pain<br /><br>* Aesthetics<br /><br>* Complications<br /><br>* Overgrowth<br /><br>* Quality of Life</p><br>