Sacral Fracture Clinical Trial
Official title:
A Prospective, Randomized Controlled Trial Comparing Percutaneous Screw Fixation to Non-Operative Management for the Treatment of Sacral Fragility Fractures
The purpose of this study is to compare percutaneous trans-iliac trans-sacral screw fixation to non-operative management for the treatment of symptomatic, sacral fragility fractures in elderly patients.
Sacral fragility fractures cause significant pain and morbidity in the elderly population in
which they occur. These low-energy pelvic injuries can cause prolonged immobility, long
hospital stays, and requirement for higher levels of care.
Subjects will undergo a 48 hour period of physical therapy and pain management following
identification of the sacral fracture.. If the subject has substantial pain or disability,
the subject is eligible for enrollment in the RCT and randomization of 1:1 to one of two
groups.
Group 1: Operative treatment: A single trans iliac trans sacral screw will be inserted at the
sacral one or sacral two level based upon fracture location.
Group 2: Conservative (non-operative) treatment: Continued pain management and physical
therapy advanced with weight bearing as tolerated.
The purpose of this study is to compare percutaneous trans-iliac trans-sacral screw fixation
to non-operative management for the treatment of symptomatic, sacral fragility fractures in
elderly patients.
Primary Objective: To compare the functional outcome and pain in elderly patients surgically
treated compared to those non-operatively treated for sacral fractures.
Secondary Objective: To compare discharge disposition, length of stay in care facility
post-discharge, complications, and need for ambulatory aid in elderly patients surgically
treated compared to those non-operatively treated for sacral fractures.
Hypothesis: Subjects in the operative group will have improvement in functional outcome and
pain at 2 weeks, higher likelihood of discharge to independent living, shorter stays in care
facilities post-discharge, less complications, and less need for ambulatory aids.
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|---|---|---|---|
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