Cone Beam Computed Tomography, Otosclerosis, Stapes Fixation
Conditions
Keywords
otosclerosis, stapedotomy, cone beam CT
Brief summary
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.
Detailed description
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).
Interventions
DIAGNOSTIC_TESTPre-operative planning based on CBCT
Pre-operative planning based on CBCT
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (\>18 years of age). * Referred to our department suspected for otosclerosis. * Consents to participation in the project.
Exclusion criteria
* 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). Inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis. | Per-operative | The diagnostic precision will be established, i.e., the sensibility and specificity for our scanning protocols. |
| Clinical decision-making in the diagnosis of suspected otosclerosis | Baseline | The proportion of patients where CBCT assists in the decision clinical decision making of otosclerosis. |
| Prothesis placement (pre-operative planning) | 12 months | Pre-operative CBCT based planning on the prothesis placement at surgery. |
| Post-operative follow-up: patient reported hearing | 12 months | The effect of pre-operative planning on the patient reported hearing at follow-up. |
| Post-operative follow-up: measured hearing | 12 months | The effect of pre-operative planning on the measured hearing (audiometry) at follow-up. |
Countries
Denmark
Outcome results
None listed