No registrations found.
ID
Source
Brief title
Health condition
spondylolisthesis, spondylolysis, stenosis, fractures, tumors, disc herniation
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is the determination of thoracolumbar sacral pedicle screw placement accuracy.
Secondary outcome
-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
Background summary
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (i.e. spinal cord, nerve roots or vertebral arteries). The objective of the study is to investigate the accuracy of screw placement during minimally invasive spine surgery.
Study objective
No formal statistical hypothesis is planned
Study design
Subjects will be followed-up from start of the interventional procedure until hospital discharge.
The total duration of the study is expected to take approximately 12 months.
Anindita Chatterjea
+31(0)615299057
anindita.chatterjea@philips.com
Anindita Chatterjea
+31(0)615299057
anindita.chatterjea@philips.com
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
-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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7956 |
| Other | SwissMedic (Lugano), Medizinische Fakultät Der Christian-Albrechts-Universität Zu Kiel (Kiel) : SwissMedic: 102607492, Medizinische Fakultät Der Christian-Albrechts-Universität Zu Kiel: 00011811 |