Ignite Creation Date:
2024-05-06 @ 1:23 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01796236
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2013-01-16
Brief Title:
Clinical and Health Economic Evaluation With a New Baha Abutment Combined With a Minimally Invasive Surgical Technique
Sponsor:
Cochlear Bone Anchored Solutions
Organization:
Cochlear Bone Anchored Solutions
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 inflammationinfection 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
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 inflammationinfection numbness and pain aesthetic outcome and utilisation of direct medical cost associated with surgery
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 inflammationinfection numbness and pain aesthetic outcome and utilisation of direct medical cost associated with surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None