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

Обзор

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.

Подробное описание

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).

Вмешательства

• Диагностический тест Pre-operative planning based on CBCT
  Pre-operative planning based on CBCT

Первичные конечные точки

• Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis. [Срок оценки: Per-operative]
• Clinical decision-making in the diagnosis of suspected otosclerosis [Срок оценки: Baseline]
• Prothesis placement (pre-operative planning) [Срок оценки: 12 months]
• Post-operative follow-up: patient reported hearing [Срок оценки: 12 months]
• Post-operative follow-up: measured hearing [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Adults (>18 years of age).
• Referred to our department suspected for otosclerosis.
• Consents to participation in the project.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Дания · 1 центр

• Rigshospitalet — Copenhagen

Идентификаторы

NCT: NCT05921578 · H-22067452

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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