Clinical trial NCT05921578: Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Official title: Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Otosclerosis
Cone Beam Computed Tomography
Stapes Fixation
Keywords: otosclerosis
stapedotomy
cone beam CT
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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.

Primary outcomes:
measure: Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis.
timeFrame: Per-operative
measure: Clinical decision-making in the diagnosis of suspected otosclerosis
timeFrame: Baseline
measure: Prothesis placement (pre-operative planning)
timeFrame: 12 months
measure: Post-operative follow-up: patient reported hearing
timeFrame: 12 months
measure: Post-operative follow-up: measured hearing
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References: