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NCT Number: NCT05921578

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.

Recruiting

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Key information

Conditions

Otosclerosis Cone Beam Computed Tomography Ear Diseases Otorhinolaryngologic Diseases Stapes Fixation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Denmark

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pre-operative planning based on CBCT

Diagnostic Test

Pre-operative planning based on CBCT

Primary outcomes

  1. Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis.

    Time frame: Per-operative

    The diagnostic precision will be established, i.e., the sensibility and specificity for our scanning protocols.

  2. Clinical decision-making in the diagnosis of suspected otosclerosis

    Time frame: Baseline

    The proportion of patients where CBCT assists in the decision clinical decision making of otosclerosis.

  3. Prothesis placement (pre-operative planning)

    Time frame: 12 months

    Pre-operative CBCT based planning on the prothesis placement at surgery.

  4. Post-operative follow-up: patient reported hearing

    Time frame: 12 months

    The effect of pre-operative planning on the patient reported hearing at follow-up.

  5. Post-operative follow-up: measured hearing

    Time frame: 12 months

    The effect of pre-operative planning on the measured hearing (audiometry) at follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Bilal H Akram

CONTACT

[email protected]

+4535451973

Steven AW Andersen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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