Long-Term Results of Bone Cement in Stapes Surgery

NCT06221007 | Completed

• 1 other identifier: 17
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Otosclerosis

Keywords

stapedotomy; otosclerosis

Outcome Measures

Primary Outcomes (1)

• Incidence of improvement of conductive hearing loss in patients using bone cement

  Changes in conductive hearing loss will be examined using pure tone audiometry testing.

  through study completion, an average of 7 year

Secondary Outcomes (3)

• Incidence of decrease in bone conduction hearing threshold in patients using bone cement

  through study completion, an average of 7 year

• Glasgow Benefit inventory

  through study completion, an average of 7 year

• Postoperative questinarie

  through study completion, an average of 7 year

Interventions

Use of bone cement in otosclerosis surgery PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Inadequate information in files

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Otosclerosis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Fazıl N Ardıç, MD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: January 24, 2024
• Study Start: August 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)