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

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ClinicalTrials.gov Identifier: NCT01796236
Recruitment Status : Completed
First Posted : February 21, 2013
Results First Posted : December 22, 2015
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions

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).


Condition or disease Intervention/treatment Phase
Deafness Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural Device: Minimally invasive surgery and BA400 Device: Traditional surgery and BA300 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Minimally invasive surgery and BA400
This arm involves no soft tissue 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).




Primary Outcome Measures :
  1. 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.

  2. Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 36 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.


Secondary Outcome Measures :
  1. Surgery Time [ Time Frame: Day 0 ]
    Surgery time (minutes) was recorded

  2. 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.

  3. Inflammation - Max of Holgers Index [ Time Frame: From Day 10 to 12 Months, and to 36 Months ]

    Max of Holgers index from day 10 to month 12, and to month 36 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection.

    0. No irritation

    1. Slight redness. Local temporary treatment, if needed
    2. Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated*
    3. Reddish and moist; sometimes granulations tissue, revision surgery is indicated* R. Removal of the abutment / implant necessary due to infection* R Removal of implant for reasons not related to skin problems*

  4. Inflammation - Holgers Index by Visit [ Time Frame: Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36 ]

    Infection and inflammation were evaluated by the holgers index at visits 3-10 (Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36) and the following scale was used:

    0. No irritation. Epidermal debris removed, if present

    1. Slight redness. Local temporary treatment, if needed
    2. Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated*
    3. Reddish and moist; sometimes granulations tissue, revision surgery is indicated*
    4. Removal of the abutment / implant necessary due to infection* R. Removal of implant for reasons not related to skin problems*

  5. Max Numbness [ Time Frame: 12 & 36 months ]

    Subjects were asked if they experience any numbness around the abutment at each visit. The maximum numbness each subject experienced is summarized in this analysis. The following scale will be used:

    1. No numbness
    2. Numbness within 2 cm from the abutment
    3. Numbness within and beyond 2 cm from the abutment

  6. Pain in the Scar and Neuropathic Pain [ Time Frame: Day 10, Weeks 3, 6, 12, 24, Months 12 and 36 ]
    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.

  7. Pain - Maximum of Neuropathic and Scar Pain [ Time Frame: 12 months ]
    The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 12 months.

  8. Pain - Maximum of Neuropathic and Scar Pain [ Time Frame: 36 months ]
    The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 36 months.

  9. Pain by Visit - Categorical [ Time Frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36 ]

    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.

    Pain scale was categorised as 1='no pain', 2-3='mild pain', 4-6='moderate pain', 7-10='severe pain'.


  10. Soft Tissue Thickening/Overgrowth [ Time Frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36 ]

    The investigator rated the implant site in regards to soft tissue thickening/overgrowth at visits 3-10 according to the following scale:

    0. No soft tissue thickening or overgrowth

    1. Slight soft tissue thickening or overgrowth
    2. Moderate soft tissue thickening or overgrowth. Local treatment and extra controls as indicated*
    3. Marked/distinct soft tissue thickening or overgrowth. Revision surgery is indicated.*

      • Should also be reported on the AE page in the CRF

  11. Visible Abutment Length by Visit for Patients With no Change of Abutment [ Time Frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36 ]

    The investigator measured the visible abutment length at each visit. The length of BA400 test abutments initially placed were longer than BA300 control abutments places. A direct comparison between the groups is not relevant.

    In some cases of increased soft tissue thickening or overgrowth, the abutment was exchanged for a longer abutment. The results presented here are only for patients with no change of abutment


  12. The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. [ Time Frame: Week 12, Months 12 and 36 ]

    The patient scale contains six items (pain, itching, color, stiffness, thickness and irregularity) scored 1-10.

    The observer scale contains six items (vascularity, pigmentation, thickness, relief, pliability and surface area) scored 1-10. Besides the 10-step scale, category boxes are available to score nominal parameters (e.g. type of color).

    Both patient and observer should also score the overall opinion of the scar on the 1-10 scale.

    For all above scales 1=normal skin, 10 worst scar imaginable.

    Total score is the sum of the variables pain, itching, color, stiffness, thickness and irregularity (patient) and vascularity, pigmentation, thickness, relief, pliability and surface area (observer). The scale ranges from 6 to 60 (6 normal, 60 worst scar imaginable).

    The "pain not with in the scar" variable ranges from 1 to 10. 1 being no pain at all and 10 being very much pain



Other Outcome Measures:
  1. Health Utilies Index (HUI-III & HUI-II) [ Time Frame: baseline (pre-surgery), week 24, months 12 and 36 ]

    Health Utilities Index (HUI) is a generic preference-based system for measuring comprehensive health status and health-related quality of life. Each index provides descriptive evidence on multiple dimensions of life quality.

    HUI3: Comprehensive Health State, Vision, Hearing, Speech, Ambulation, Emotion, Cognition, Pain.

    HUI2: Comprehensive Health State, Sensation, Mobility, Emotion, Cognition, Self Care, Pain.

    Subjects completed HUI2/3 questionnaires at visit 1 (baseline), 7 (week 24), 8 (month 12) and 10 (month 36).

    HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead.


  2. Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: Pre-surgery (baseline) to 24 weeks, 12 and 36 months ]

    The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item self-assessment, disability-based inventory that can be used to document the outcome of a hearing aid fitting, to compare several fittings, or to evaluate the same fitting over time. The subjects will complete the APHAB at pre-surgery, week 24, month 12 and 36.

    Questions assess 'Ease of Communication', 'Background Noise', 'Reverberation', 'Aversiveness', and 'Global' in the aided and unaided situations. The aided situation was compared to the unaided situation at baseline (pre-surgery).

    For each subscale, a score of 99 indicates that there is 'always' difficulty, and a score of 1 indicated that there is 'never' difficulty for that particular subscale.


  3. Use of Sound Processor [ Time Frame: Weeks 6, 12, 24, Months 12, 24, 36 ]
    Use of the sound processor can be seen as a reflection of patient satisfaction and treatment compliance. Patients were asked to record how many hours per week they used the sound processor after Baha loading at week 3.

  4. Implant Stability (ISQ) [ Time Frame: Surgery, Day 10, Weeks 3, 6, 12, 24, Months 12, 24, 36 ]

    ISQ is a well-established method to measure stability of osseointegrated implants and has been used for several years both for bone conduction implants and for dental implants. Measurements were performed using resonance frequency analysis at the abutment level. The highest and lowest ISQ value out of two perpendicular measurements obtained at each time point was recorded, ISQ High and ISQ Low. The ISQ values ranges from 1 to 100.

    Overall, the length of test abutments (BA400) were longer than control abutments (BA300) and there is an inverse correlation between abutment length and stability. A direct comparison between the groups is not relevant.

    Implant Stability Quotient (ISQ) was recorded at surgery as a baseline value and at visit 2-10.


  5. Smoking Habits by Visit [ Time Frame: baseline, Weeks 3, 12, Months 12, 24 and 36 ]

    Nicotine use and smoking habits were recorded for patients.

    1. Does not smoke
    2. Less than 10 cigarettes/day (Low consumption)
    3. Between 11 and 20 cigarettes/day (Medium consumption)
    4. Between 21 and 40 cigarettes/day (High consumption)
    5. More than 40 cigarettes/day (Very high consumption)

    In Sweden a large proportion of adults use another form of tobacco, wet snuff. In Sweden the patients were asked if they used wet snuff.


  6. Loss of Implant [ Time Frame: from surgery through to 36 months ]
    'Loss of Implant' refers to the loss of the implant for reasons including failure of implant to osseointegrate, or an implant that was loose form surgery. It does not include elected removal of the device.

  7. Removal of Abutment [ Time Frame: from surgery through to 36 months ]
    Count of subjects who had their abutment removed for reasons of health and safety, such as infection, inflammation or pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796236


Locations
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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
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Principal Investigator: Robert Stokroos, Professor NT department, Oxford Building , Peter Debyelaan 25, 6202 AZ Maastricht, The Netherlands
  Study Documents (Full-Text)

Documents provided by Cochlear Bone Anchored Solutions:
Statistical Analysis Plan  [PDF] July 3, 2015
Study Protocol  [PDF] September 19, 2013


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Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT01796236     History of Changes
Other Study ID Numbers: CBAS5439
First Posted: February 21, 2013    Key Record Dates
Results First Posted: December 22, 2015
Last Update Posted: February 26, 2019
Last Verified: February 2019
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:
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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