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.
Cone-beam CT has a high resolution and a low effective radiation dose to the patient when compared to conventional CT-scans. Surgical treatment of otosclerosis is primarily by stapedotomy. The decision of surgical treatment is currently based on the history, clinical examination, and audiological tests, but stapes fixation can only be confirmed per-operatively. This protocol includes the following overall aims for the following studies: * To establish the diagnostic precision of clinical CBCT in diagnosing otoslcerosis, i.e., the sensibility and specificity for our scanning protocols (n=50). * To determine if CBCT can support the clinicians' decision making in the diagnosis of otosclerosis (n=100). * To assess the value of CBCT in the planning of stapes surgery. Two groups will be established: CBCT-based pre-operative planning (e.g., prothesis parameters and anatomic landmarks) and no-planning (standard treatment). Patients will be allocated by 1:1 randomization (n=75). * To assess the value of CBCT in the post-operative follow-up of 2-3 weeks, 2-3 months, and 12 months. Follow-up includes a clinical examination, audiometry, CBCT (block-randomized), and patient questionnaires (audiometry and patient questionnaire not at the "2-3 weeks" control) (n=75). * To assess the value of pre-preoperative CBCT on post-surgical result at follow up (2-3 weeks, 2-3, months and 12-months) (n=75).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
100
Pre-operative planning based on CBCT
Rigshospitalet
Copenhagen, Denmark
RECRUITINGDiagnostic 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-operative
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: Baseline
Prothesis placement (pre-operative planning)
Pre-operative CBCT based planning on the prothesis placement at surgery.
Time frame: 12 months
Post-operative follow-up: patient reported hearing
The effect of pre-operative planning on the patient reported hearing at follow-up.
Time frame: 12 months
Post-operative follow-up: measured hearing
The effect of pre-operative planning on the measured hearing (audiometry) at follow-up.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.