Comparison of a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method

Study Overview
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Brief Summary
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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 Cube® 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).

Detailed Description
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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 Cube® 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 Cube® 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).

Official Title
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Prospective, Randomized, Controlled, Parallel Group Study to Compare a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method

Conditions
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Lumbar Pain

Intervention / Treatment
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* Device: Free-hand therapeutic CT-guided punction for lumbar pain
* Device: Puncture Cube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring a percutaneous therapeutic CT-guided intervention for lumbar pain (joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level) age ≥ 18 years Signed informed consent prior to intervention Exclusion Criteria: Patients suffering from severe obesity (BMI > 30 kg/m2)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, controlled, parallel group study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Free-hand lumbar punction<br>Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the free-hand method. | Device: Free-hand therapeutic CT-guided punction for lumbar pain<br>* Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.<br>|
| Active Comparator: Puncture Cube<br>Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device. | Device: Puncture Cube<br>* Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | during procedure time approximately 30 min. | 
| Assessment of intervention time | Assessment of intervention time | during procedure time approximately 30 min. |