Long-Term Results of Bone Cement in Stapes Surgery

Otosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06221007
• Other study ID #: 17
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Pamukkale University
• Contact: Fazil N Ardic, MD
• Phone: 902582965799
• Email: fnecdetardic[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Inadequate information in files

Related Conditions & MeSH terms

• Otosclerosis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	february'2024-april'2024
Secondary	Incidence of decrease in bone conduction hearing threshold in patients using bone cement	The change in sensorineural hearing threshold will be examined using pure tone audiometry test.	february'2024-april'2024