In patients presenting with Type A and Type B1, B2 thoracolumbar fractures, there is a lack of evidence demonstrating similar outcomes between patients treated with percutaneous pedicle screws and those treated openly. It has been demonstrated that percutaneous pedicle screw fixation has fared well for patients in the short term; however, it is unclear whether the outcomes are equivalent or inferior/superior compared to open treatment. The authors seek to establish a high-level evidence base to determine clinical patient outcomes, radiographic outcomes, as well as cost-effectiveness data in comparing thoracolumbar burst fracture patients treated with percutaneous pedicle screws, open treatment, and brace treatment. Additionally, the authors seek to establish data relating to patient occupational data, complications, and need for further surgery (revision/removal of hardware), as well as short-term variables relating to hospital visit (length of stay, estimated blood loss, time under fluoroscopy).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Percutaneous Pedicle Screw Fixation
Midline posterior incision with instrumentation.
Allegheny General Hospital, Department or Orthopaedic Surgery
Pittsburgh, Pennsylvania, United States
Change in Health Related Quality of Life Measure Scores
Oswestry Disability Index, Roland Morris Disability Score, Visual Analog Spine Score, Euroqol 5D-5L
Time frame: 24 months
Radiographic Evaluations
Kyphosis
Time frame: 24 months
Cost Effectiveness
Time frame: Duration of Hospital Stay (expected duration average 1 week)
Complication rate/Adverse event
Time frame: 24 months
Additional medical procedures
Any additional medical procedures outside of the index surgery.
Time frame: 24 months
Length of Hospital Stay
Time frame: Duration of hospital stay (expected duration average 1 week)
Estimated Blood Loss
Estimated blood loss, operating time, fluoroscopy time
Time frame: Duration of hospital visit (expected duration- average 1 week)
Return to work
Time frame: 24 months
Radiographic Evaluation
Loss of height
Time frame: 24 months
Operating Time
The time it takes to complete the index surgery from start to finish.
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Time frame: Duration of hospital visit (expected duration 1 week)
Fluoroscopy time
Duration of time the fluoroscopy was in use during the index surgery
Time frame: Duration of hospital stay (expected duration average 1 week)