Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique
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).
|Deafness Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural||Device: Minimally invasive surgery and BA400 Device: Traditional surgery and BA300|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ]
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.
- Numbness [ Time Frame: 12 months ]Numbness summary analysis.
- Pain in the Scar and Neuropathic Pain [ Time Frame: Day 10, Weeks 3, 6, 12, 24 and Month 12 ]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.
- Wound Healing [ Time Frame: Day 10, Weeks 3, 6, 12 and 24 ]A surgeon or a surgical nurse determined if the wound was healed or not healed.
- Surgery Time [ Time Frame: Day 0 ]Surgery time (minutes) was recorded
- Inflammation [ Time Frame: Day 10 to 12 Months ]Max of Holgers index from day 10 to month 12 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||July 2017|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Minimally invasive surgery and BA400
This arm involves no softtissue reduction around the BA400 implant.
Device: Minimally invasive surgery and BA400
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).
Active Comparator: Traditional surgery and BA300
This arm involves traditional soft tissue reduction around the BA300 implant
Device: Traditional surgery and BA300
The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796236
|Toulouse, France, 31059|
|KNO arts, Amphia Ziekenhuis|
|Eindhoven, Netherlands, 5623|
|Maastricht, Netherlands, 6202|
|Otorhinolaryngology, Hospital Clinico Universitario De Valencia|
|Valencia, Spain, ES-46010|
|Gothenburg, Sweden, 411 35|
|Principal Investigator:||Robert Stokroos, Professor||NT department, Oxford Building , Peter Debyelaan 25, 6202 AZ Maastricht, The Netherlands|