Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
Our studies will systematically investigate and establish evidence on whether Cone-beam computed tomography (CBCT) of the temporal bone could be used in the diagnosis and treatment of otosclerosis and in the post-operative follow-up after stapedotomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (>18 years of age).
Referred to our department suspected for otosclerosis.
Consents to participation in the project.
Disqualifiers
A history of surgical treatment for otosclerosis (ipsilateral ear).
A history of tympanoplasty type 2-4 (ipsilateral ear).
Other competing middle-ear diseases (ipsilateral ear).
Trial design
Design model
Parallel
Treatments tested in this trial
Pre-operative planning based on CBCT
Diagnostic testPre-operative planning based on CBCT
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Routine diagnostic workupNo intervention 0 interventions
Group B: Routine diagnostic workup + pre-operative CBCT-based planningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis.
The diagnostic precision will be established, i.e., the sensibility and specificity for our scanning protocols.
Time frame
Per-operative2
Clinical decision-making in the diagnosis of suspected otosclerosis
The proportion of patients where CBCT assists in the decision clinical decision making of otosclerosis.
Time frame
Baseline3
Prothesis placement (pre-operative planning)
Pre-operative CBCT based planning on the prothesis placement at surgery.
Time frame
12 months4
Post-operative follow-up: patient reported hearing
The effect of pre-operative planning on the patient reported hearing at follow-up.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov