Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier:
NCT01796236
First received: January 16, 2013
Last updated: January 28, 2016
Last verified: January 2016
  Purpose

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).


Condition Intervention
Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Device: Minimally invasive surgery and BA400
Device: Traditional surgery and BA300

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cochlear Bone Anchored Solutions:

Primary Outcome Measures:
  • Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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.


Secondary Outcome Measures:
  • Numbness [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Numbness summary analysis.

  • Pain in the Scar and Neuropathic Pain [ Time Frame: Day 10, Weeks 3, 6, 12, 24 and Month 12 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    A surgeon or a surgical nurse determined if the wound was healed or not healed.

  • Surgery Time [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
    Surgery time (minutes) was recorded

  • Inflammation [ Time Frame: Day 10 to 12 Months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 106
Study Start Date: February 2013
Estimated Study Completion Date: June 2017
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796236

Locations
France
Service ORL
Toulouse, France, 31059
Netherlands
KNO arts, Amphia Ziekenhuis
Breda, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Dept. ENT/KNO
Eindhoven, Netherlands, 5623
NT department
Maastricht, Netherlands, 6202
Spain
Otorhinolaryngology, Hospital Clinico Universitario De Valencia
Valencia, Spain, ES-46010
Sweden
ENT Clinic
Gothenburg, Sweden, 411 35
Sponsors and Collaborators
Cochlear Bone Anchored Solutions
Investigators
Principal Investigator: Robert Stokroos, Professor NT department, Oxford Building , Peter Debyelaan 25, 6202 AZ Maastricht, The Netherlands
  More Information

Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT01796236     History of Changes
Other Study ID Numbers: CBAS5439 
Study First Received: January 16, 2013
Results First Received: November 18, 2015
Last Updated: January 28, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Sweden: Regional Ethical Review Board

Keywords provided by Cochlear Bone Anchored Solutions:
Bone anchored hearing aid
Bone anchored implant
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Health Utility Index (HUI)
Holgers Index
Implant stability

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on December 07, 2016