S32.0 M46.4 M43.1 S22.0
Conditions
Interventions
Group 1: 3D C-arm-based Pulse-navigated Pedicle screw placement (imaging system: Siemens Cios Spin 3D, navigation system: NuVasive Pulse)
Group 2: intraoperative computed tomography-based navigated pe
Sponsors
Sektionsleiter WirbelsäulenchirurgieKlinik für Unfallchirurgie und OrthopädieBG Klinik Ludwigshafen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged 18 years and older who have been indicated for surgical treatment of a pathology in the thoracic and/or lumbar spine using dorsal instrumentation and who have given informed consent to surgery are eligible for inclusion.
Exclusion criteria
Exclusion criteria: Exclusion criteria are dislocation fractures of the spine (type C according to AO Spine Classification) as well as revision surgery of the spine and interventions. In addition, patients are excluded if there are doubts about their ability to consent or if they do not have this ability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically relevant screw malposition rate on intraoperative (after completion of screw placement) or postoperative 3D imaging corresponding to grade C-E (>2mm) of the Gertzbein and Robbins classification. | — |
Secondary
| Measure | Time frame |
|---|---|
| operating time and navigation time intraoperative radiation dose postoperative complications (infections, neurological, wound healing disorder, postoperative bleeding/hematoma, revision surgery) postoperative pain/painkiller requirement length of hospital stay | — |
Countries
Germany
Contacts
Public ContactEric Mandelka
AssistenzarztKlinik für Unfallchirurgie und OrthopädieBG Klinik Ludwigshafen
Outcome results
None listed