Long-Term Results of Bone Cement in Stapes Surgery

NCT ID: NCT06221007

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Otosclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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Use of bone cement in otosclerosis surgery

Surgical technique; It involves separating the sclerosed stapes from the oval window and incus under an endoscope or microscope and replacing it with a Teflon piston, which is a middle ear prosthesis. In this way, a new connection between the incus and the oval window ensures the transmission of sound to the inner ear. Bone cement has long been used in primary and revision ossiculoplasty, including stapedotomy of the middle ear. During stapedotomy, the part of the Teflon piston that places the teflon piston on the incus is fixed with bone cement, aiming to keep the prosthesis in place for a long time and prophylactic treatment of incus necrosis.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Inadequate information in files
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Fazıl Necdet Ardıç

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fazıl N Ardıç, MD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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17

Identifier Type: -

Identifier Source: org_study_id

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