Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique

Study Overview
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Brief Summary
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To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment). To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due to shorter surgical procedures, faster wound healing and less complications compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).

Detailed Description
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Despite extensive soft tissue reduction, the most common complications associated with Baha implants are related to adverse skin reactions around the abutment. The reduction of the skin also adds complexity to the surgical procedure that is otherwise a routine type of skin incision. A less invasive surgical technique avoiding reducing the thickness of the skin would render a simpler and shorter procedure and would be aesthetically appealing to the patients, as permanent hair removal in the area around the abutment would not be required. Faster healing and less numbness (sensory loss/ paraesthesia) at the implant site may also be expected if the soft tissue thickness is left intact. The Cochlea Baha BA300 Abutment together with a surgical procedure that includes soft tissue reduction was CE marked in April 2010. The test abutment, Cochlear Baha BA400, together with a surgical procedure that does not require soft tissue reduction was CE marked in June 2012. The rationale behind this investigation was to make a 'head-to-head' comparison between the BA300 and BA400 Abutment and the associated surgical techniques in order to collect information regarding complications (inflammation/infection, numbness and pain), aesthetic outcome and utilisation of direct medical cost associated with surgery.

Official Title
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Clinical and Health Economic Evaluation of a New Baha® Abutment, With a Minimally Invasive Surgical Technique. An International Multicentre, Open, Randomised, Comparative, Parallel Group, Investigation. 1y Investigation, 2y Follow-up

Conditions
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Deafness, Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural

Intervention / Treatment
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* Device: Minimally invasive surgery and BA400
* Device: Traditional surgery and BA300


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Minimally invasive surgery and BA400<br>This arm involves no soft tissue reduction around the BA400 implant. | Device: Minimally invasive surgery and BA400<br>* The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).<br>|
| Active Comparator: Traditional surgery and BA300<br>This arm involves traditional soft tissue reduction around the BA300 implant | Device: Traditional surgery and BA300<br>* The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: Holgers Index >=2 any time between 3 weeks to 1 year Any overgrowth any time between 3 weeks to 1 year Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject. | 12 months | 
| Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: Holgers Index >=2 any time between 3 weeks to 1 year Any overgrowth any time between 3 weeks to 1 year Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery Time | Surgery time (minutes) was recorded | Day 0 | 
| Wound Healing | A surgeon or a surgical nurse determined if the wound was healed or not healed. | Day 10, Weeks 3, 6, 12 and 24 | 
| Inflammation - Max of Holgers Index | Max of Holgers index from day 10 to month 12, and to month 36 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection. 0. No irritation Slight redness. Local temporary treatment, if needed Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated* Reddish and moist; sometimes granulations tissue, revision surgery is indicated* R. Removal of the abutment / implant necessary due to infection* R Removal of implant for reasons not related to skin problems* | From Day 10 to 12 Months, and to 36 Months | 
| Inflammation - Holgers Index by Visit | Infection and inflammation were evaluated by the holgers index at visits 3-10 (Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36) and the following scale was used: 0. No irritation. Epidermal debris removed, if present Slight redness. Local temporary treatment, if needed Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated* Reddish and moist; sometimes granulations tissue, revision surgery is indicated* Removal of the abutment / implant necessary due to infection* R. Removal of implant for reasons not related to skin problems* | Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36 | 
| Max Numbness | Subjects were asked if they experience any numbness around the abutment at each visit. The maximum numbness each subject experienced is summarized in this analysis. The following scale will be used: No numbness Numbness within 2 cm from the abutment Numbness within and beyond 2 cm from the abutment | 12 & 36 months | 
| Pain in the Scar and Neuropathic Pain | The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much. | Day 10, Weeks 3, 6, 12, 24, Months 12 and 36 | 
| Pain - Maximum of Neuropathic and Scar Pain | The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 12 months. | 12 months | 
| Pain - Maximum of Neuropathic and Scar Pain | The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 36 months. | 36 months | 
| Pain by Visit - Categorical | The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much. Pain scale was categorised as 1='no pain', 2-3='mild pain', 4-6='moderate pain', 7-10='severe pain'. | Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36 | 
| Soft Tissue Thickening/Overgrowth | The investigator rated the implant site in regards to soft tissue thickening/overgrowth at visits 3-10 according to the following scale: 0. No soft tissue thickening or overgrowth Slight soft tissue thickening or overgrowth Moderate soft tissue thickening or overgrowth. Local treatment and extra controls as indicated* Marked/distinct soft tissue thickening or overgrowth. Revision surgery is indicated.* Should also be reported on the AE page in the CRF | Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36 | 
| Visible Abutment Length by Visit for Patients With no Change of Abutment | The investigator measured the visible abutment length at each visit. The length of BA400 test abutments initially placed were longer than BA300 control abutments places. A direct comparison between the groups is not relevant. In some cases of increased soft tissue thickening or overgrowth, the abutment was exchanged for a longer abutment. The results presented here are only for patients with no change of abutment | Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36 | 
| The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | The patient scale contains six items (pain, itching, color, stiffness, thickness and irregularity) scored 1-10. The observer scale contains six items (vascularity, pigmentation, thickness, relief, pliability and surface area) scored 1-10. Besides the 10-step scale, category boxes are available to score nominal parameters (e.g. type of color). Both patient and observer should also score the overall opinion of the scar on the 1-10 scale. For all above scales 1=normal skin, 10 worst scar imaginable. Total score is the sum of the variables pain, itching, color, stiffness, thickness and irregularity (patient) and vascularity, pigmentation, thickness, relief, pliability and surface area (observer). The scale ranges from 6 to 60 (6 normal, 60 worst scar imaginable). The pain not with in the scar variable ranges from 1 to 10. 1 being no pain at all and 10 being very much pain | Week 12, Months 12 and 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone anchored hearing aid, Bone anchored implant, Abbreviated Profile of Hearing Aid Benefit (APHAB), Health Utility Index (HUI), Holgers Index, Implant stability