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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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, Investi

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 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 Summary:

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.

Sponsor: Cochlear Bone Anchored Solutions

Current Primary Outcome: Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ]

Original Primary Outcome:

• Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 10 ]

  Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events:

  1. Holgers Index >=2 any time between 3 weeks to 1 year
  2. Any overgrowth any time between 3 weeks to 1 year
  3. Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year
  4. Any numbness any time between 3 weeks to 1 year
• Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Week 3 ]
• Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Week 6 ]
• Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Week 12 ]
• Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Week 24 ]
• Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Month 12 ]
• Number of participants with local Adverse Events as a measure of safety and tolerability [ Time Frame: Month 24 ]
• Number of participants with local Adverse Events as a measure of safety and tolerability [
  
  

  Current Secondary Outcome:

  • 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.
  
  
  

  Original Secondary Outcome: Total cost of the surgical procedure, complications and number of wound dressings sessions [ Time Frame: Day 10, Weeks 3, 6, 12, 24 and Months 12, 24, 36 ]

  Direct medical cost associated with the surgery (time to perform surgery, number of wound dressings sessions and cost to treat complications) will be calculated for each subject using standard cost/unit in each participating country.
  
  
  Information By: Cochlear Bone Anchored Solutions
  

  Dates:
  Date Received: January 16, 2013
  Date Started: February 2013
  Date Completion: July 2017
  Last Updated: February 2, 2017
  Last Verified: February 2017