Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pre-operative planning based on CBCT.
- Who it may be relevant to
- Registry conditions: Otosclerosis, Cone Beam Computed Tomography, Stapes Fixation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test Pre-operative planning based on CBCT
Pre-operative planning based on CBCT
Primary outcome measures
- Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis. [Time frame: Per-operative]
- Clinical decision-making in the diagnosis of suspected otosclerosis [Time frame: Baseline]
- Prothesis placement (pre-operative planning) [Time frame: 12 months]
- Post-operative follow-up: patient reported hearing [Time frame: 12 months]
- Post-operative follow-up: measured hearing [Time frame: 12 months]
Eligibility criteria
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 exclusion criteria for patients enrolled for post-surgical follow-up are the same as above in addition to:
Exclusion:
\- Intraoperative findings not supporting otosclerosis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Identifiers
NCT: NCT05921578 · H-22067452