OtosclerosisNCT06221007
Long-Term Results of Bone Cement in Stapes Surgery
An observational study of Otosclerosis, run by Pamukkale University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otosclerosis
- What is being tested?
- Use of bone cement in otosclerosis surgery
- Type of treatment
- Surgery or procedure
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Stapedotomy surgeries performed at Pamukkale University ENT clinic since 2011 will be examined retrospectively.
Who may be able to join
- Patients over the age of 18 who underwent stapedotomy with a diagnosis of otosclerosis
Who cannot join
- Inadequate information in files
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Use of bone cement in otosclerosis surgery
- Keywords
- stapedotomy, otosclerosis
- Medical subject headings
- Otosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of bone cement in otosclerosis surgeryProcedure or 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022
Secondary outcomes (3)
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.
Measured: This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022
Glasgow Benefit inventory
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.
Measured: This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022
Postoperative questinarie
16 items stapedotomy specific questions
Measured: This retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Aug 2024
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
- Investigators
- Fazıl N Ardıç, MD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221007
- Sponsor's protocol ID
- 17
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-Term Results of Bone Cement Application in Stapes Surgery and Factors Effective on Results in Stapes Surgery
- ClinicalTrials.gov ID
- NCT06221007
- Acronym / sponsor ID
- 17
- Conditions
- Otosclerosis
- Keywords
- stapedotomy, otosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Stapedotomy surgeries performed at Pamukkale University ENT clinic since 2011 will be examined retrospectively.
Key inclusion criteria (1 listed)
- Patients over the age of 18 who underwent stapedotomy with a diagnosis of otosclerosis
Key exclusion criteria (1 listed)
- Inadequate information in files
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of bone cement in otosclerosis surgerySurgical 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. | Procedure or surgery | – |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Otosclerosis
Active, not recruiting
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Otosclerosis, Cone Beam Computed Tomography
Not yet recruiting
Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
Otosclerosis
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fazıl N Ardıç, MD principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otosclerosis, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.