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NCT Number: NCT06221007

Long-Term Results of Bone Cement 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.

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Key information

Conditions

Otosclerosis Ear Diseases Otorhinolaryngologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University

Denizli, 20100, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inadequate information in files

Treatment and study plan

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.

Primary outcomes

  1. Incidence of improvement of conductive hearing loss in patients using bone cement

    Time frame: This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022

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

Secondary outcomes

  1. Incidence of decrease in bone conduction hearing threshold in patients using bone cement

    Time frame: This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022

    The change in sensorineural hearing threshold will be examined using pure tone audiometry test.

  2. Glasgow Benefit inventory

    Time frame: This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022

    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.

  3. Postoperative questinarie

    Time frame: This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022

    16 items stapedotomy specific questions

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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