| 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
|
|
|
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
|
|
|
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. |