M53.26 M43.16 M43.17 M43.06 M47.26
Conditions
Interventions
Group 1: Conventional fluoroscopy (FLUORO group)
Group 2: 3D fluoroscopy-based navigation (NAV group)
Sponsors
Neurochirurgische Universitätsklinik Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Full age to competent patients with planned mono- or bisegmental MIS TLIF between LWK 2 and SWK 1 due to degeneration and / or instability including spondylolisthesis Meyerding grade I and II. • Both imaging techniques are considered suitable for MIS TLIF. • No improvement in symptoms for at least 3 months under conservative treatment. • Pain score (VAS for low back pain) of at least 3/10.
Exclusion criteria
Exclusion criteria: • Previous surgery in the affected or directly adjacent vertebral segment. • Spondylodiscitis, traumatic instability, osteoporotic vertebral fractures, neoplastic disease of the operating segment(s), spondylolisthesis Meyerding grade III and IV. • Indication for stabilization > 2 segments. • One of the imaging techniques is not considered suitable for MIS TLIF. • Scoliosis with a Cobb angle > 10 ° in the operating segment(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation exposure of the surgeon, operating room staff and patient per monosegmental MIS TLIF in the FLUORO and NAV group (measured with dosimeters) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Radiation exposure of patients with bisegmental MIS TLIF in the FLUORO and NAV group - Radiation exposure of the surgeon, operating room staff and patient depending on the body mass index (BMI) of patients in the FLUORO and NAV group - Radiation exposure of the surgeon, operating room staff and patient per MIS TLIF with or without cement augmentation - Clinical outcome (examination findings, questionnaires), fusion rate (follow-up, 12 months) - Comparison of the accuracy of pedicle screws in the FLUORO and NAV group - Comparison of the parameters of the sagittal balance (C7 plumb line, segmental / lumbar lordosis, pelvic tilt, sacral slope, pelvic incidence) between follow-up (12 months) and preoperatively in the FLUORO and NAV group in lateral X-rays | — |
Countries
Germany
Contacts
Public ContactJan-Helge Klingler
Neurochirurgische Universitätsklinik Freiburg
Outcome results
None listed