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In a prospective, randomized, controlled, parallel group study the accuracy, intervention time and radiation dose of CT-guided punctures using the Puncture CubeĀ® will be compared to the conventional free-hand method in patients requiring a percutaneous diagnostic or therapeutic CT-guided intervention for lumbar pain (facet joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level).
Computed tomography (CT)-guided interventions for diagnostic and therapeutic purposes are standard approaches in clinical routine (e.g. in patients with low back pain). Numerous CT needle navigation systems have been developed with the aim to improve accuracy (and thus safety) of punctures while decreasing radiation exposure and procedure time. Their usability in clinical routine is limited either because of high sensitivity to interference, high expenses, bulkiness, or incompatibly with daily clinical practice and thus increasing procedure time and workflow complexity. The Puncture CubeĀ® takes into account all these requirements. Furthermore, in an in vitro-phantom study (study submitted for publication), punctures with the Cube were found to be faster and more accurate compared to the free-hand conventional method.
In a prospective, randomized, controlled, parallel group study the accuracy, intervention time and radiation dose of CT-guided punctures using the Puncture CubeĀ® will be compared to the conventional free-hand method in patients requiring a percutaneous diagnostic or therapeutic CT-guided intervention for lumbar pain (facet joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free-hand lumbar punction | Other | Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the free-hand method. |
|
| Puncture Cube | Active Comparator | Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture CubeĀ® as a needle navigation device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free-hand therapeutic CT-guided punction for lumbar pain | Device | Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture CubeĀ® as a needle navigation device. |
| Measure | Description | Time Frame |
|---|---|---|
| Puncture accuracy | Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory) | during procedure time approximately 30 min. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of control acquisitions to achieve target | Number of control acquisitions to achieve target | during procedure time approximately 30 min. |
| Assessment of radiation dose | Assessment of radiation dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Remonda, Prof. | Contact | +41 62 838 43 21 | luca.remonda@ksa.ch |
| Name | Affiliation | Role |
|---|---|---|
| Luca Remonda, Prof. | Department of Neuroradiology, Kantonsspital Aarau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neuroradiology, Kantonsspital Aarau | Recruiting | Aarau | Canton of Aargau | 5001 | Switzerland |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Prospective, randomized, controlled, parallel group study
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| Puncture Cube | Device | Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture CubeĀ® as a needle navigation device. |
|
| during procedure time approximately 30 min. |
| Assessment of intervention time | Assessment of intervention time | during procedure time approximately 30 min. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |