Pedicle screw placement in the thoracic and lumbar spine: comparison of two navigation systems with the conventional method under 2D fluoroscopy.

Phase 4

Recruiting

Conditions: S32.0
M46.4
M43.1
S22.0
Fracture of lumbar vertebra
Discitis, unspecified
Spondylolisthesis
Fracture of thoracic vertebra

Registration Number: DRKS00027635

Lead Sponsor: Sektionsleiter WirbelsäulenchirurgieKlinik für Unfallchirurgie und OrthopädieBG Klinik Ludwigshafen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 180

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 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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
operating time and navigation time<br>intraoperative radiation dose<br>postoperative complications (infections, neurological, wound healing disorder, postoperative bleeding/hematoma, revision surgery)<br>postoperative pain/painkiller requirement<br>length of hospital stay