Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical decision-making in the diagnosis of suspected otosclerosis
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years of age).
- •Referred to our department suspected for otosclerosis.
- •Consents to participation in the project.
排除标准
- •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:
- •- Intraoperative findings not supporting otosclerosis.
研究组 & 干预措施
Routine diagnostic workup
Routine diagnostic workup + pre-operative CBCT-based planning
干预措施: Pre-operative planning based on CBCT (Diagnostic Test)
结局指标
主要结局
Clinical decision-making in the diagnosis of suspected otosclerosis
时间窗: Baseline
The proportion of patients where CBCT assists in the decision clinical decision making of otosclerosis.
Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis.
时间窗: Per-operative
The diagnostic precision will be established, i.e., the sensibility and specificity for our scanning protocols.
Post-operative follow-up: measured hearing
时间窗: 12 months
The effect of pre-operative planning on the measured hearing (audiometry) at follow-up.
Post-operative follow-up: patient reported hearing
时间窗: 12 months
The effect of pre-operative planning on the patient reported hearing at follow-up.
Prothesis placement (pre-operative planning)
时间窗: 12 months
Pre-operative CBCT based planning on the prothesis placement at surgery.
次要结局
未报告次要终点
研究者
Steven Andersen
M.D., PhD, Senior Researcher
Rigshospitalet, Denmark