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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine diagnostic workup | No Intervention | ||
| Routine diagnostic workup + pre-operative CBCT-based planning | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-operative planning based on CBCT | Diagnostic Test | Pre-operative planning based on CBCT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Per-operative |
| Clinical decision-making in the diagnosis of suspected otosclerosis | The proportion of patients where CBCT assists in the decision clinical decision making of otosclerosis. | Baseline |
| Prothesis placement (pre-operative planning) | Pre-operative CBCT based planning on the prothesis placement at surgery. | 12 months |
| Post-operative follow-up: patient reported hearing | The effect of pre-operative planning on the patient reported hearing at follow-up. | 12 months |
| Post-operative follow-up: measured hearing | The effect of pre-operative planning on the measured hearing (audiometry) at follow-up. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bilal H Akram | Contact | +4535451973 | bilal.hussain.akram@regionh.dk | |
| Steven AW Andersen | Contact | steven.andersen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D010040 | Otosclerosis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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