Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery

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Brief Title

Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery

Official Title

Clinical Applications of Round Window High Resolution Computerised Tomography Anatomy in Cochlear Implant Surgery

Brief Summary

      The purpose of this study is to measure the size of the round window niche and its relation
      to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution
      computerized tomography of the temporal bone, in order to assess preoperatively what is the
      extent of obstruction of the round window membrane and whether there is a surgical
      possibility of round window approach in the insertion of electrode array into the cochlea
    

Detailed Description

      The assessment of the anatomy of the round window will be executed using the stractured
      measuring software used for imaging of the Bnai Zion medical center (CARESTREAM PACS Ver.
      11.0, CARSTREAM HEALTH INC.) in IAC window (centered at 700 with a total width of 4000) in
      the available zoom by the software (usually 400-800%).

      Measuring the length (mm) and angle will be executed by the software's structured rulers.

      Measuring protocol:

        1. Measured scans: one taken in an orbito-meatal plane

        2. Chosen slices: where both the round window niche and the external ear canal are seen on
           the same slice

        3. Distances measured:

             1. Distance 1: between the anterior edge of the round window niche and the cortex of
                the mastoid, with a minimal distance of 0.5mm to the posterior wall of the external
                ear canal

             2. Distance 2: between the posterior edge of the round window niche and the cortex of
                the mastoid, with a minimal distance of 0.3mm to the anterior edge of the mastoid
                segment of the facial nerve.

             3. Distance 3: the size of the round window niche (from its anterior to posterior
                edges)

             4. Distance 4: between the anterior (most medial) edge of the round window membrane to
                a point at least 0.3mm anterior to the mastoid segment of the facial nerve.

             5. Distance 5: between the posterior (most lateral) edge of the round window membrane
                to a point at least 0.3mm anterior to the mastoid segment of the facial nerve

             6. Distance 6: size of round window membrane (anterior/medial to posterior/lateral)

             7. Distance 7: between the lateral edges of distance 1 and 2 marking the cortical size
                of the "working channel" created between the lines (from the cortex to the round
                window).

        4. Angles measured:

             1. Between distance 1 and 7 - marking the angle of the "working channel" relatively to
                the cortex

             2. Between distance 1, passing in the middle of distance 3 to the middle of distance 6
                - marking the angle of possible insertion from the working channel into the cochlea
    


Study Type

Observational


Primary Outcome

the size of round window niche and its relation to the cochlea

Secondary Outcome

 sizes of working channel from the mastoid cortex into the round window membrane and its relation to the mastoid sagment of the facial nerve

Condition

Sensorineural Hearing Loss (Disorder)

Intervention

measurment

Study Arms / Comparison Groups

 CT of the temporal bone
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

January 2014


Primary Completion Date

June 2015

Eligibility Criteria

        Inclusion Criteria:

          -  age 20 years old or older

          -  high resolution computerized tomography of the temporal bone (slices ≤1mm) before the
             surgery

          -  on the measured slices both the round window niche and the posterior wall of the
             external ear canal are seen

        Exclusion Criteria:

          -  inner, middle or external ear malformation

          -  temporal bone malformation

          -  status post cochlear implant

          -  status post temporal bone trauma

          -  slices were the round window niche and the posterior wall of the external ear canal
             are not seen on the same slice
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michal Luntz, Prof., , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT02093806

Organization ID

0140-13-BNZ

Secondary IDs

0140-13-BNZ

Responsible Party

Principal Investigator

Study Sponsor

Bnai Zion Medical Center


Study Sponsor

Michal Luntz, Prof., Principal Investigator, chair of otorhinolaryngology department at the Bnai Zion medical center


Verification Date

December 2014