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CTRI Number  CTRI/2024/07/071366 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Outcome of hearing in synthetic versus body tissue prosthesis in ear surgeries 
Scientific Title of Study   Outcome of hearing in Partial ossicular replacement prosthesis versus cartilage autograft in ossiculoplasty : A comparative study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitika Singh 
Designation  Post Graduate Trainee  
Affiliation  Institute of Post graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital 
Address  Department of ENT 3rd floor Chest and Cancer Block Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital 244, AJC Bose Road

Kolkata
WEST BENGAL
700020
India 
Phone  9051980250  
Fax    
Email  nitika96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arunabha Sengupta 
Designation  Professor 
Affiliation  Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital  
Address  Department of ENT 3rd floor Chest and Cancer Block Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital 244, AJC Bose Road

Kolkata
WEST BENGAL
700020
India 
Phone  9831089737  
Fax    
Email  arunabhasengupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nitika Singh 
Designation  Post Graduate Trainee  
Affiliation  Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital 
Address  Department of ENT 3rd floor Chest and Cancer Block Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital 244, AJC Bose Road

Kolkata
WEST BENGAL
700020
India 
Phone  9051980250  
Fax    
Email  nitika96@gmail.com  
 
Source of Monetary or Material Support  
Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital 244, AJC Bose Road Kolkata 700020 West Bengal, India. 
 
Primary Sponsor  
Name  Arunabha Sengupta 
Address  3rd floor, Department of ENT IPGMER & SSKM Hospital 244 AJC Bose Road Kolkata 700020 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nitika Singh  Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital   Department of ENT 3rd floor Chest and Cancer Block
Kolkata
WEST BENGAL 
9051980250

nitika96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H673||Otitis media in diseases classified elsewhere, bilateral,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cartilage autograft   Use of patients own cartilage for middle ear ossicular reconstruction Time taken - 2-3 hrs 
Intervention  Partial Ossicular replacement prosthesis   Use of prosthesis for middle ear ossicular reconstruction Time Taken - 2-3 hrs 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Hearing test to determine whether patient hears better with cartilage or prosthesis  1 month
3 months
6 months
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Failure of the cartilage autograft or prosthesis  1 month
3 months
6 months
12 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   26/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 extensive chronic 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.

 
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