spondylolisthesis, spondylolysis, stenosis, fractures, tumors, disc herniation
Conditions
Interventions
None listed
Sponsors
Philips Medical Systems Nederland B.V.
Eligibility
Inclusion criteria
Inclusion criteria: -Subject will be undergoing a percutaneous spine surgery with thoracolumbar sacral pedicle screw placement in a maximum of 4 levels to stabilize the spine for spine pathologies like spondylolisthesis, spondylolysis, stenosis, fractures, tumors, disc herniation. -Subject is able to give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law
Exclusion criteria
Exclusion criteria: -Subject participates in a potentially confounding drug- or device trial during the course of the study. -All vulnerable subjects such as adults lacking the capacity to provide consent, patients in emergency situations, pregnant or breast feeding women, or any other subject who meets an exclusion criteria, according to applicable national laws, if any -All subjects who are employees of the parties involved in the study -The distance between the skin entry point and the position of the Bone access needle tip inside the pedicle should not exceed 108 mm as this may obscure the tracking marker on the needle shaft, potentially causing failure of device tracking functionality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the determination of thoracolumbar sacral pedicle screw placement accuracy. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Average time required for complete surgical procedure (skin incision to skin closure) -Average time to place screw in optimum position. -Patient dose -Operator radiation dose -User feedback on workflow usability -Adverse events -Adverse device effects -Device deficiencies that could have led to a serious adverse event -Comparison of obtained accuracy with accuracy data from the pre-clinical cadaver study | — |
Contacts
Public ContactAnindita Chatterjea
Philips Medical Systems Nederland B.V.
Outcome results
None listed