OtosclerosisQUIPROCOSNCT02901093
Quantification of Prosthesis Penetration With Conebeam in Otosclerosis
An observational study of Otosclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Sensorineural complications of stapes surgery are rare but potentially serious. Imaging is usually performed to identify an underlying cause, such as excessive intravestibular penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otosclerosis
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2014to Dec 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing stapes surgery for otosclerosis
Who may be able to join
- age >= 18 years old
- patients undergoing stapes surgery for otosclerosis
Who cannot join
- patient's refusal to participate in the study
- patient under legal protection
- no medical insurance coverage
- pregnant or breast feeding patient
About this study
Official title: Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome
Sensorineural complications of stapes surgery are rare but potentially serious. Imaging is usually performed to identify an underlying cause, such as excessive intravestibular penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula.
Unfortunately, there is very little data in an unselected series of uneventful patients.
The aim of this study is to analyze the depth of prosthesis penetration within the vestibule and the rate of pneumolabyrinth the day or the day after the procedure by performing a Cone Beam CT (CBCT) of the temporal bone in a cohort of unselected patients, and to correlate imaging findings to clinical outcome. This prospective monocentric study is conducted in a tertiary referral medical center. A CBCT is performed in 80 consecutive patients having undergone stapes surgery for otosclerosis, the day or the day after the procedure. Penetration length and location of the prosthesis within the vestibule, as well as presence or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo, nystagmus, hearing measurement).
- Conditions
- Otosclerosis
- Keywords
- Stapes surgery, Sensorineural complications, Inner ear, Imaging, Cone Beam CT
- Medical subject headings
- Otosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
location of the medial tip of the prosthesis within the vestibule
computerized tomography with cone beam
Measured: 1 day after surgery
intravestibular length of the prosthesis
computerized tomography with cone beam
Measured: 1 day after surgery
incidence of postoperative pneumolabyrinth
computerized tomography with cone beam
Measured: 1 day after surgery
incidence of vertigo
clinical assessment
Measured: 1 day after surgery
incidence of nystagmus
clinical assessment
Measured: 1 day after surgery
change in pure-tone bone conduction hearing thresholds
measured at 250, 500, 1000, 2000, 3000, 4 000 Hz
Measured: between baseline and 1 day after surgery
Pure-tone audiometry
Measured: 7 days, 1 month and 3 months after surgery
bone conduction hearing thresholds
Measured: 7 days, 1 month and 3 months after surgery
Speech Discrimination
audiometry: Speech Discrimination Score at a standard presentation level of 60 decibels (SDS60) expressed in percentages
Measured: baseline, 1 month and 3 months after surgery
Speech Reception
audiometry: Speech Reception Threshold at 50% (SRT50) and/or 100% (SRT100) expressed in dB
Measured: baseline, 1 month and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start25 Sep 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901093
- Sponsor's protocol ID
- DAE_2014_15
- Acronym
- QUIPROCOS
- Status last verified
- Mar 2017
- First submitted
- 7 Sep 2016
- Last updated
- 27 Nov 2017
- Results posted
- No
Publications
Vandevoorde A, Williams MT, Ukkola-Pons E, Daval M, Ayache D. Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome. Otol Neurotol. 2017 Feb;38(2):168-172. doi: 10.1097/MAO.0000000000001306.
PubMed 28068300
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome
- ClinicalTrials.gov ID
- NCT02901093
- Acronym / sponsor ID
- QUIPROCOS / DAE_2014_15
- Conditions
- Otosclerosis
- Keywords
- Stapes surgery, Sensorineural complications, Inner ear, Imaging, Cone Beam CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 25 Sep 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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.
Sensorineural complications of stapes surgery are rare but potentially serious. Imaging is usually performed to identify an underlying cause, such as excessive intravestibular penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula.
Unfortunately, there is very little data in an unselected series of uneventful patients.
The aim of this study is to analyze the depth of prosthesis penetration within the vestibule and the rate of pneumolabyrinth the day or the day after the procedure by performing a Cone Beam CT (CBCT) of the temporal bone in a cohort of unselected patients, and to correlate imaging findings to clinical outcome. This prospective monocentric study is conducted in a tertiary referral medical center. A CBCT is performed in 80 consecutive patients having undergone stapes surgery for otosclerosis, the day or the day after the procedure. Penetration length and location of the prosthesis within the vestibule, as well as presence or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo, nystagmus, hearing measurement).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing stapes surgery for otosclerosis
Key inclusion criteria (2 listed)
- age >= 18 years old
- patients undergoing stapes surgery for otosclerosis
Key exclusion criteria (4 listed)
- patient's refusal to participate in the study
- patient under legal protection
- no medical insurance coverage
- pregnant or breast feeding patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
location of the medial tip of the prosthesis within the vestibule
Time frame: 1 day after surgery
computerized tomography with cone beam
intravestibular length of the prosthesis
Time frame: 1 day after surgery
computerized tomography with cone beam
incidence of postoperative pneumolabyrinth
Time frame: 1 day after surgery
computerized tomography with cone beam
incidence of vertigo
Time frame: 1 day after surgery
clinical assessment
incidence of nystagmus
Time frame: 1 day after surgery
clinical assessment
change in pure-tone bone conduction hearing thresholds
Time frame: between baseline and 1 day after surgery
measured at 250, 500, 1000, 2000, 3000, 4 000 Hz
Pure-tone audiometry
Time frame: 7 days, 1 month and 3 months after surgery
bone conduction hearing thresholds
Time frame: 7 days, 1 month and 3 months after surgery
Speech Discrimination
Time frame: baseline, 1 month and 3 months after surgery
audiometry: Speech Discrimination Score at a standard presentation level of 60 decibels (SDS60) expressed in percentages
Speech Reception
Time frame: baseline, 1 month and 3 months after surgery
audiometry: Speech Reception Threshold at 50% (SRT50) and/or 100% (SRT100) expressed in dB
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 27 Nov 2017.
- Results publication: PubMed 28068300Vandevoorde A, Williams MT, Ukkola-Pons E, Daval M, Ayache D. Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome. Otol Neurotol. 2017 Feb;38(2):168-172. doi: 10.1097/MAO.0000000000001306.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Otosclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 2 inclusion and 4 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 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
location of the medial tip of the prosthesis within the vestibule (time frame: 1 day after surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02901093, which also lists 1 linked publication.
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 27 Nov 2017.