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

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.

Study Overview

• Status: Recruiting
• Conditions: Otosclerosis; Cone Beam Computed Tomography; Stapes Fixation
• Intervention / Treatment: Diagnostic test: Pre-operative planning based on CBCT

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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven AW Andersen; Email: steven.andersen@regionh.dk
• Study Contact Backup: Name: Bilal H Akram; Phone Number: +4535451973; Email: bilal.hussain.akram@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine diagnostic workup
Experimental: Routine diagnostic workup + pre-operative CBCT-based planning	Diagnostic test: Pre-operative planning based on CBCT; Pre-operative planning based on CBCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Prothesis placement (pre-operative planning)	Pre-operative CBCT based planning on the prothesis placement at surgery.	12 months
Post-operative follow-up: patient reported hearing	The effect of pre-operative planning on the patient reported hearing at follow-up.	12 months
Post-operative follow-up: measured hearing	The effect of pre-operative planning on the measured hearing (audiometry) at follow-up.	12 months

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: cone beam CT; otosclerosis; stapedotomy
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otosclerosis
• Other Study ID Numbers: H-22067452

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No