No formal statistical hypothesis is planned
ID
Bron
Verkorte titel
Aandoening
spondylolisthesis, spondylolysis, stenosis, fractures, tumors, disc herniation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint of the study is the determination of thoracolumbar sacral pedicle screw placement accuracy.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
No formal statistical hypothesis is planned
Onderzoeksopzet
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.
Publiek
Anindita Chatterjea
+31(0)615299057
anindita.chatterjea@philips.com
Wetenschappelijk
Anindita Chatterjea
+31(0)615299057
anindita.chatterjea@philips.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7956 |
| Ander register | SwissMedic (Lugano), Medizinische Fakultät Der Christian-Albrechts-Universität Zu Kiel (Kiel) : SwissMedic: 102607492, Medizinische Fakultät Der Christian-Albrechts-Universität Zu Kiel: 00011811 |