跳至主要内容
临床试验/CTRI/2024/07/071366
CTRI/2024/07/071366招募中3 期

Outcome of hearing in Partial ossicular replacement prosthesis versus cartilage autograft in ossiculoplasty : A comparative study

Arunabha Sengupta1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月26日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Hearing test to determine whether patient hears better with cartilage or prosthesis

研究概览

简要总结

Chronic otitis media is one of the leading causes of preventable hearing loss in patients in developing countries. Often there is erosion of the ossicles with or without an intact tympanic membrane. Such patients commonly present with moderate to severe hearing loss, with evidence of erosion. In cases where the incus is absent or eroded to a point that it cannot assist in conduction of sound in the middle ear, with an intact stapes suprastructure, the need of an autograft or a prosthesis comes into play. Autografting is commonly done using tragal or conchal cartilages, and prosthesis used are Partial or Total Ossicular Replacement Prosthesis (PORP/TORP).

Long standing and extensivechronic otitis media often causes erosion of the incudostapedial joint with or without an intact malleus, whether it is a squamosal or mucosal disease. The aim of ear surgeries in this case are eradication of the disease and reconstruction of the sound conduction mechanism. Numerous ossiculoplasty techniques have been used to reconstruct the ossicular chain.

Ossiculoplasty material should be ideally biocompatible, stable, safe, affordable and easily available. Autograft, homograft and synthetic prosthesis are widely being used for ossicular reconstruction. In this study conchal cartilage autograft and partial ossicular replacement prosthesis  have been used for ossicular reconstruction. The purpose of this study is to evaluate the experience with ossicular reconstruction for ossicular discontinuity at the incudostapedial joint, with intact stapes suprastructure and malleus, using cartilage autograft and PORP and comparing their hearing results at 1 month, 3 months , 6 months, and 12 months  as well as the failure rates between the two.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with chronic otitis media Patients having moderate conductive hearing loss on audiometry Patients with radiological evidence of ossicular erosion Patients willing to participate through informed written consent.

排除标准

  • Patients diagnosed with squamosal type of chronic otitis media with evidence of Cholesteatoma Patients planned for canal wall down with ossicuoplasty procedure Patients having sensorineural hearing loss on audiometry Patients with history of previous ear surgery Patients unfit for anaesthesia Patients with comorbidities or immune suppression.

结局指标

主要结局

Hearing test to determine whether patient hears better with cartilage or prosthesis

时间窗: 1 month | 3 months | 6 months | 12 months

次要结局

  • Failure of the cartilage autograft or prosthesis(1 month)

研究者

发起方
Arunabha Sengupta
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Nitika Singh

Institute of Post graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital

研究点 (1)

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