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Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.

Primary Purpose

Otosclerosis, Cone Beam Computed Tomography, Stapes Fixation

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pre-operative planning based on CBCT
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Otosclerosis focused on measuring otosclerosis, stapedotomy, cone beam CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults (>18 years of age). Referred to our department suspected for otosclerosis. Consents to participation in the project. Exclusion Criteria: A history of surgical treatment for otosclerosis (ipsilateral ear). A history of tympanoplasty type 2-4 (ipsilateral ear). Other competing middle-ear diseases (ipsilateral ear). Inclusion and exclusion criteria for patients enrolled for post-surgical follow-up are the same as above in addition to: Exclusion: - Intraoperative findings not supporting otosclerosis.

Sites / Locations

  • RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine diagnostic workup

Routine diagnostic workup + pre-operative CBCT-based planning

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis.
The diagnostic precision will be established, i.e., the sensibility and specificity for our scanning protocols.
Clinical decision-making in the diagnosis of suspected otosclerosis
The proportion of patients where CBCT assists in the decision clinical decision making of otosclerosis.
Prothesis placement (pre-operative planning)
Pre-operative CBCT based planning on the prothesis placement at surgery.
Post-operative follow-up: patient reported hearing
The effect of pre-operative planning on the patient reported hearing at follow-up.
Post-operative follow-up: measured hearing
The effect of pre-operative planning on the measured hearing (audiometry) at follow-up.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
September 7, 2023
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05921578
Brief Title
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Official Title
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Our studies will systematically investigate and establish evidence on whether Cone-beam computed tomography (CBCT) of the temporal bone could be used in the diagnosis and treatment of otosclerosis and in the post-operative follow-up after stapedotomy.
Detailed Description
Cone-beam CT has a high resolution and a low effective radiation dose to the patient when compared to conventional CT-scans. Surgical treatment of otosclerosis is primarily by stapedotomy. The decision of surgical treatment is currently based on the history, clinical examination, and audiological tests, but stapes fixation can only be confirmed per-operatively. This protocol includes the following overall aims for the following studies: To establish the diagnostic precision of clinical CBCT in diagnosing otoslcerosis, i.e., the sensibility and specificity for our scanning protocols (n=50). To determine if CBCT can support the clinicians' decision making in the diagnosis of otosclerosis (n=100). To assess the value of CBCT in the planning of stapes surgery. Two groups will be established: CBCT-based pre-operative planning (e.g., prothesis parameters and anatomic landmarks) and no-planning (standard treatment). Patients will be allocated by 1:1 randomization (n=75). To assess the value of CBCT in the post-operative follow-up of 2-3 weeks, 2-3 months, and 12 months. Follow-up includes a clinical examination, audiometry, CBCT (block-randomized), and patient questionnaires (audiometry and patient questionnaire not at the "2-3 weeks" control) (n=75). To assess the value of pre-preoperative CBCT on post-surgical result at follow up (2-3 weeks, 2-3, months and 12-months) (n=75).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otosclerosis, Cone Beam Computed Tomography, Stapes Fixation
Keywords
otosclerosis, stapedotomy, cone beam CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine diagnostic workup
Arm Type
No Intervention
Arm Title
Routine diagnostic workup + pre-operative CBCT-based planning
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Pre-operative planning based on CBCT
Intervention Description
Pre-operative planning based on CBCT
Primary Outcome Measure Information:
Title
Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis.
Description
The diagnostic precision will be established, i.e., the sensibility and specificity for our scanning protocols.
Time Frame
Per-operative
Title
Clinical decision-making in the diagnosis of suspected otosclerosis
Description
The proportion of patients where CBCT assists in the decision clinical decision making of otosclerosis.
Time Frame
Baseline
Title
Prothesis placement (pre-operative planning)
Description
Pre-operative CBCT based planning on the prothesis placement at surgery.
Time Frame
12 months
Title
Post-operative follow-up: patient reported hearing
Description
The effect of pre-operative planning on the patient reported hearing at follow-up.
Time Frame
12 months
Title
Post-operative follow-up: measured hearing
Description
The effect of pre-operative planning on the measured hearing (audiometry) at follow-up.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (>18 years of age). Referred to our department suspected for otosclerosis. Consents to participation in the project. Exclusion Criteria: A history of surgical treatment for otosclerosis (ipsilateral ear). A history of tympanoplasty type 2-4 (ipsilateral ear). Other competing middle-ear diseases (ipsilateral ear). Inclusion and exclusion criteria for patients enrolled for post-surgical follow-up are the same as above in addition to: Exclusion: - Intraoperative findings not supporting otosclerosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bilal H Akram
Phone
+4535451973
Email
bilal.hussain.akram@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Steven AW Andersen
Email
steven.andersen@regionh.dk
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.

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