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Outcome of hearing in synthetic versus body tissue prosthesis in ear surgeries

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071366
Enrollment
80
Registered
2024-07-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H673- Otitis media in diseases classified elsewhere, bilateral

Interventions

Intervention1: Partial Ossicular replacement prosthesis: Use of prosthesis for middle ear ossicular reconstruction Time Taken - 2-3 hrs Control Intervention1: Cartilage autograft: Use of patients own

Sponsors

Arunabha Sengupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Hearing test to determine whether patient hears better with cartilage or prosthesisTimepoint: 1 month 3 months 6 months 12 months

Secondary

MeasureTime frame
Failure of the cartilage autograft or prosthesisTimepoint: 1 month 3 months 6 months 12 months

Countries

India

Contacts

Public ContactNitika Singh

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

arunabhasengupta@gmail.com9831089737

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026