We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01796236
First Posted: February 21, 2013
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions
January 16, 2013
February 21, 2013
November 18, 2015
December 22, 2015
March 14, 2017
February 2013
June 2015   (Final data collection date for primary outcome measure)
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:

  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 Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.
  • 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 [ Time Frame: Month 36 ]
Complete list of historical versions of study NCT01796236 on ClinicalTrials.gov Archive Site
  • 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.
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.
Not Provided
  • Aesthetic outcome [ Time Frame: Months 6, 12 and 36 ]
    Patient and Observer Scar Assessment Scale (POSAS) v 2.0
  • Quality of Life [ Time Frame: Baseline Months 6, 12 and 36 ]
    Health Utility Index and Abbreviated Profile of Hearing Aid Benefit
  • Adverse Events [ Time Frame: Day 10, Weeks 3, 6, 12, 24 and Months 12, 24, 36 ]
 
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

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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Deafness
  • Hearing Loss
  • Hearing Loss, Conductive
  • Hearing Loss, Mixed Conductive-Sensorineural
  • 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).
  • Active Comparator: Minimally invasive surgery and BA400
    This arm involves no softtissue reduction around the BA400 implant.
    Intervention: Device: Minimally invasive surgery and BA400
  • Active Comparator: Traditional surgery and BA300
    This arm involves traditional soft tissue reduction around the BA300 implant
    Intervention: Device: Traditional surgery and BA300
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
106
July 2017
June 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Netherlands,   Spain,   Sweden
 
 
NCT01796236
CBAS5439
No
Not Provided
Not Provided
Cochlear Bone Anchored Solutions
Cochlear Bone Anchored Solutions
Not Provided
Principal Investigator: Robert Stokroos, Professor NT department, Oxford Building , Peter Debyelaan 25, 6202 AZ Maastricht, The Netherlands
Cochlear Bone Anchored Solutions
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP