NCT01796236

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Cochlear Bone Anchored Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-06-01
• Completion: 2017-11-01
• First posted: 2013-02-21
• Last updated: 2019-02-26
• Results posted: 2015-12-22

Locations

7 sites across 4 countries: France, Netherlands, Spain, Sweden