NCT06221007

Long-Term Results of Bone Cement in Stapes Surgery

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Pamukkale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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.

Conditions

• Otosclerosis

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2024-01-24
• Last updated: 2025-09-25

Locations

1 site across 1 country: Turkey (Türkiye)