Long-Term Results of Bone Cement in Stapes Surgery

September 21, 2025 updated by: Fazıl Necdet Ardıç, Pamukkale University

Evaluation of Long-Term Results of Bone Cement Application in Stapes Surgery and Factors Effective on Results in Stapes Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Stapedotomy surgeries performed at Pamukkale University ENT clinic since 2011 will be examined retrospectively.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Inadequate information in files

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of improvement of conductive hearing loss in patients using bone cement
Time Frame: through study completion, an average of 7 year
Changes in conductive hearing loss will be examined using pure tone audiometry testing.
through study completion, an average of 7 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of decrease in bone conduction hearing threshold in patients using bone cement
Time Frame: through study completion, an average of 7 year
The change in sensorineural hearing threshold will be examined using pure tone audiometry test.
through study completion, an average of 7 year
Glasgow Benefit inventory
Time Frame: through study completion, an average of 7 year
The GBI is an 18-item, validated instrument designed specifically to assess patient-perceived benefits following otolaryngologic interventions. It utilizes a five-point Likert scale. The score is changing between -100(worst) and +100(best). Total scores interpreted as follows: >50 indicates significant benefit, 10-50 indicates moderate benefit, and <10 denotes no perceived benefit.
through study completion, an average of 7 year
Postoperative questinarie
Time Frame: through study completion, an average of 7 year
16 items stapedotomy specific questions
through study completion, an average of 7 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Fazıl N Ardıç, MD, Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

January 13, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 21, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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