Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively

Study Overview
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Brief Summary
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Feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (PalpEar).

Detailed Description
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The aim of this study was to develop and test a palpating instrument, which enables the experienced and occasional otologic surgeon to record force in three dimensions during his standard palpation of each ossicle at surgery and al-lows correlation of his subjective impression with objective measurement results. The first task was to incorporate force sensing capability into a standard 45° angulated 2.5 mm hook, which is commonly used to palpate, disconnect and luxate ossicles during middle ear surgery.

Official Title
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Messung Der Beweglichkeit Der Gehörknöchelchenkette während Einer Ohroperation. (Objective Measurements of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively)

Conditions
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Disorder of Middle Ear, Otosclerosis of Middle Ear, Cholesteatoma, Middle Ear

Intervention / Treatment
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* Device: PalpEar


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adult subjects Normally scheduled for middle-ear or internal-ear surgery as a result of an ear disease and for whom a routine assessment of the mobility of the ossicle chain is in order. The targeted subject population consists of patients undergoing stapedotomy for otosclerosis and subjects with a normal ossicular chain who are subject to the placement of a cochlear implant to treat hearing loss. Exclusion criteria: Children Subjects in whom the ossicle chain is missing or incomplete Missing informed consent form Incapacitated subjects or subjects with impaired judgment capability.

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PalpEar<br>Intraoperative palpation of the ossicles using the PalpEar device, to measure mobility of the ossicle chain. | Device: PalpEar<br>* Palpation of the middle-ear ossicles using the PalpEar device, to measure mobility of the ossicle chain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the ossicle mobility through the palpation force | The palpation forces needed to move the middle-ear ossicles out from their resting position will be measured through a force sensing device. The measured palpation forces are measured in equivalent gram-force [gF]. The primary outcome of the study is to demonstrate if a relation can be established between the subjective feeling of the surgeon and an objective measurement of the palpation force. | 1 day. The measurements are performed during day 1, in parallel with the underlying surgery, and therefore assessed within the time frame of 1 day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between normal and impaired ossicular chains | A comparison between ossicular chains judged as normal by the surgeon and impaired ossicular chains will be performed, to assess if a significant difference can be extracted from the measurement of the palpation force. This would help in a future diagnosis assisted by a force sensing device. | 1 day. The measurements are performed during day 1, in parallel with the underlying surgery, and therefore assessed within the time frame of 1 day. |