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临床试验/NCT06221007
NCT06221007已完成不适用

Evaluation of Long-Term Results of Bone Cement Application in Stapes Surgery and Factors Effective on Results in Stapes Surgery

Pamukkale University1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
1
主要终点
Incidence of improvement of conductive hearing loss in patients using bone cement

研究概览

简要总结

Considering the long-term results of otosclerosis surgery performed in our clinic, it was observed that in addition to the improvement in air conduction hearing, which indicates conductive hearing, which is the main success of the surgery, there was also an improvement in bone conduction hearing, which indicates sensorineural hearing, in patients using bone cement.

Our study aimed to examine the effect of bone cement use in otosclerosis surgery on long-term hearing thresholds and bone conduction.

详细描述

A retrospective review was conducted on records of patients who underwent stapes surgery between 2012 and 2020.

Comprehensive records were selected, and patients were summoned for clinic visits for thorough examinations. Evaluation encompassed the average of air and bone conduction at 500, 1000, 2000, and 4000 Hz. A procedure-specific 16-item questionnaire and the Glasgow Benefit Inventory (GBI) were used for perceived benefit and effective factors.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over the age of 18 who underwent stapedotomy with a diagnosis of otosclerosis

排除标准

  • Inadequate information in files

结局指标

主要结局

Incidence of improvement of conductive hearing loss in patients using bone cement

时间窗: through study completion, an average of 7 year

Changes in conductive hearing loss will be examined using pure tone audiometry testing.

Incidence of improvement of conductive hearing loss in patients using bone cement

时间窗: This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022

Changes in conductive hearing loss will be examined using pure tone audiometry testing.

次要结局

  • Glasgow Benefit inventory(through study completion, an average of 7 year)
  • Incidence of decrease in bone conduction hearing threshold in patients using bone cement(through study completion, an average of 7 year)
  • Postoperative questinarie(through study completion, an average of 7 year)
  • Incidence of decrease in bone conduction hearing threshold in patients using bone cement(This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022)
  • Glasgow Benefit inventory(This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022)
  • Postoperative questinarie(This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fazıl Necdet Ardıç

Prof Dr

Pamukkale University

研究点 (1)

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