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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
Results First Submitted: November 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Interventions: Device: Minimally invasive surgery and BA400
Device: Traditional surgery and BA300

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
106 subjects signed informed consent. Before surgery one subject cancelled surgery, one subject withdraw consent and one subject got the wrong allocation due to logistic problems. This resulted in that 103 subjects received the allocated intervention (51 test and 52 control).

Reporting Groups
  Description
Minimally Invasive Surgery and BA400

This arm involves no soft tissue reduction around the BA400 implant.

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). The abutment is available in four different lengths (6, 8, 10 and 12 mm)

Traditional Surgery and BA300

This arm involves traditional soft tissue reduction around the BA300 implant

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).


Participant Flow:   Overall Study
    Minimally Invasive Surgery and BA400   Traditional Surgery and BA300
STARTED   51   52 
COMPLETED   49   50 
NOT COMPLETED   2   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Minimally Invasive Surgery and BA400

This arm involves no soft tissue reduction around the BA400 implant.

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). The abutment is available in four different lengths (6, 8, 10 and 12 mm)

Traditional Surgery and BA300

This arm involves traditional soft tissue reduction around the BA300 implant

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).

Total Total of all reporting groups

Baseline Measures
   Minimally Invasive Surgery and BA400   Traditional Surgery and BA300   Total 
Overall Participants Analyzed 
[Units: Participants]
 51   52   103 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.2  (10.9)   51.5  (16.6)   52.4  (14.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      25  49.0%      27  51.9%      52  50.5% 
Male      26  51.0%      25  48.1%      51  49.5% 
Region of Enrollment 
[Units: Participants]
     
Netherlands   26   29   55 
Sweden   5   4   9 
France   5   5   10 
Spain   15   14   29 
Use of nicotine 
[Units: Participants]
     
No   37   38   75 
Yes   14   13   27 
Unknown   0   1   1 
Type of hearing loss 
[Units: Participants]
     
Conductive   5   10   15 
Mixed   31   35   66 
Single-Sided Sensorineural   15   7   22 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Numbness   [ Time Frame: 12 months ]

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

4.  Secondary:   Wound Healing   [ Time Frame: Day 10, Weeks 3, 6, 12 and 24 ]

5.  Secondary:   Surgery Time   [ Time Frame: Day 0 ]

6.  Secondary:   Inflammation   [ Time Frame: Day 10 to 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Professor Robert Stokroos
Organization: Head and Neck Surgery, Maastricht University Medical Center, Maastricht
phone: 0031 - 43 387 54 00
e-mail: robert.stokroos@mumc.nl



Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT01796236     History of Changes
Other Study ID Numbers: CBAS5439
First Submitted: January 16, 2013
First Posted: February 21, 2013
Results First Submitted: November 18, 2015
Results First Posted: December 22, 2015
Last Update Posted: March 14, 2017