Vestibular Function Outcome After Cartilage Cap Occlusion Surgery

Study Overview
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Brief Summary
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The primary objective of this study is to measure objective, functional outcomes of patients undergoing cartilage cap occlusion surgery for a dehiscent superior semicircular canal.

Detailed Description
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One option for managing a dehiscent superior semicircular canal is surgical intervention. One of the surgical techniques is the transmastoid and tegmen mini-craniotomy cartilage cap occlusion of the dehiscent superior semicircular canal.

Official Title
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Objective Assessment of Vestibular Function Outcome After Cartilage Cap Occlusion Surgery for Dehiscent Superior Semicircular Canal

Conditions
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Vestibular Dizziness, Superior Semicircular Canal Dehiscence

Intervention / Treatment
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* Procedure: cartilage cap occlusion surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ambulatory independent self-sufficient adults good general health medically stable Exclusion Criteria: Medically unstable pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical Group<br>patients will undergo a primary transmastoid and tegmen mini-craniotomy cartilage cap occlusion surgery. | Procedure: cartilage cap occlusion surgery<br>* placement of a cartilage cap over the dome of the superior semicircular canal through a combined transmastoid and tegmen mini- craniotomy approach.<br>|
| No Intervention: Non Surgical Group<br>patients meet the same criteria but will elect not to undergo surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective improvement | The primary outcome measure will be the subsequent (3 month) FGA scores between the control group and the surgery group to assess any objective improvement attributable to surgery | baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABC Scale | Secondary objective outcome measures will be changes in conductive hearing loss and changes in cervical VEMP thresholds between the two groups at the 3-month interval. Secondary subjective outcome measures will be ABC Scale and VAS scores between the two groups at 3 months. | baseline to 3 months | 
| VAS scores | Secondary objective outcome measures will be changes in conductive hearing loss and changes in cervical VEMP thresholds between the two groups at the 3-month interval. Secondary subjective outcome measures will be ABC Scale and VAS scores between the two groups at 3 months. | baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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superior semicircular canal, non-vestibular dizziness, vestibular dizziness