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

Last updated: April 1, 2025
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Hearing Impairment

Treatment

Pre-operative planning based on CBCT

Clinical Study ID

NCT05921578
H-22067452
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults (>18 years of age).

  • Referred to our department suspected for otosclerosis.

  • Consents to participation in the project.

Exclusion

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 Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Pre-operative planning based on CBCT
Phase:
Study Start date:
May 17, 2023
Estimated Completion Date:
December 31, 2025

Study 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).

Connect with a study center

  • Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

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