Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.

Otosclerosis Clinical Trial

Official title:

Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921578
• Other study ID #: H-22067452
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Rigshospitalet, Denmark
• Contact: Bilal H Akram
• Phone: +4535451973
• Email: bilal.hussain.akram[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cone Beam Computed Tomography
• Otosclerosis

Intervention

Diagnostic Test:
• Pre-operative planning based on CBCT
Pre-operative planning based on CBCT

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Per-operative
Primary	Clinical decision-making in the diagnosis of suspected otosclerosis	The proportion of patients where CBCT assists in the decision clinical decision making of otosclerosis.	Baseline
Primary	Prothesis placement (pre-operative planning)	Pre-operative CBCT based planning on the prothesis placement at surgery.	12 months
Primary	Post-operative follow-up: patient reported hearing	The effect of pre-operative planning on the patient reported hearing at follow-up.	12 months
Primary	Post-operative follow-up: measured hearing	The effect of pre-operative planning on the measured hearing (audiometry) at follow-up.	12 months