Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. Depending on the type of injury there are various methods available to stabilize the spine. The proposed study should clarify whether the combined reduction and fixation with a minimally invasive approach can actually be done with the same precision as in a conventional approach. The primary endpoint of this investigation is the monosegmental anterior wedge angle (AWA), and its maintenance over the first 6 postoperative weeks. It is the aim of the study to gather key radiological, clinical and subjective patient outcome parameters for its patient population that will allow to compare the results to a historical group of patients. The study design is non-interventional, prospective, open,and multicentric.
Study Type
OBSERVATIONAL
Enrollment
24
Thoracolumbar Fracture Fixation
Vinzenz-Pallotti-Hospital
Bergisch Gladbach, Germany
Universitätsklinik Bonn, Abteilung für Unfallchirurgie
Bonn, Germany
Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln
Cologne, Germany
Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen
Wermelskirchen, Germany
Anterior wedge angle (AWA)
Time frame: 6 weeks
Blood loss of the patient during surgery to stabilize the spine fracture
Time frame: intraoperative
OP duration
Time frame: intraoperative
Adverse events
Time frame: Intraop and Postop
VAS Spine Score
Time frame: 3 days and 6 weeks
VAS pain score
Time frame: 3 days and 6 weeks
accompanying pain medication (or "self medication")
Time frame: 6 weeks
patient satisfaction with operational results
The patient is asked the question whether he is satisfied with the results of the operation, he has the choice between six answers: very satisfied, satisfied, partly satisfied, unsatisfied, no comment
Time frame: 6 weeks
Hospital length of stay
Time frame: discharge
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