Lateral compression-1 (LC1) pelvic ring fragility fractures cause significant pain and morbidity. These fragility injuries are associated with prolonged immobility and long hospital stays. Currently there is no consensus on operative stabilization of LC1 pelvic fractures, nor are there evidence-based guidelines to aid in management of these injury types. Furthermore, there is variability in operative indications, improvement in pain and mobilization. The purpose of this study is to compare percutaneous screw fixation to non-operative management in symptomatic LC1 fragility fractures in elderly patients.
This study is a prospective, randomized control trial (RCT) of 100 patients with fragility pelvic ring fractures. All patients presenting with pelvic ring fractures classified as LC1 confirmed with plain radiographs, CT and/or MRI, resulting from a low energy mechanism or an insufficiency fracture without a precipitating event will undergo a trial of physical therapy with mobilization and multimodal pain management. If the subject has substantial posterior pelvic pain (score ≥ 7 with the Visual Analogue Scale (VAS)) or inability to ambulate after the physical therapy trial for 48 hours, the subject is eligible for enrollment in the RCT. Patients will either be grouped into an operative group, defined as percutaneous screw fixation, or a nonoperative group, defined as treatment with physical therapy and pain management only. 1. Group 1-Operative treatment: Percutaneous screw fixation will be performed for stabilization of the pelvic fracture 2. Group 2-Conservative (non-operative) treatment: Pain management and physical therapy advanced with weight bearing as tolerated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Surgical intervention in the form of percutaneous screw fixation
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Allina, Mercy Hospital
Coon Rapids, Minnesota, United States
RECRUITINGPark Nicollet, Methodist Hospital
Saint Louis Park, Minnesota, United States
RECRUITINGHealthPartners, Regions Hospital
Saint Paul, Minnesota, United States
RECRUITINGTimed Up and Go (TUG) assessment
Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of physical therapy to get up from a chair, walk 3 meters turn around walk 3 meters back to the chair and sit down.
Time frame: Day 2 after treatment
Sacral Region Pain by Visual Analog Scale
Patient reported pain on a scale of 0-10. Minimum score 0 (no pain) to maximum score 10 (worst possible pain)
Time frame: Day 2, 2 weeks, 6 weeks, and 3 months after treatment
Timed Up and Go (TUG) assessment
Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of physical therapy to get up from a chair, walk 3 meters turn around walk 3 meters back to the chair and sit down.
Time frame: 2 weeks, 6 weeks, and 3 months after treatment
Discharge Disposition Location
Where a patient went after being discharged from the hospital (home, rehabilitation center, skilled nursing facility)
Time frame: Post discharge from treatment, an average of 5 days from being admitted to the hospital
Longest Distance of Ambulation
How far a patient was able to walk
Time frame: Day 2 after treatment
Use of Narcotic Pain Medication
Use of narcotic pain medication, total in milligram equivalents (MME)
Time frame: Day 2 after treatment
Hospital Length of Stay
Number of days admitted to hospital during treatment
Time frame: Post discharge from treatment, an average of 5 days from being admitted to the hospital
Rate of Complications
Unplanned surgery, new neurological deficit after treatment, surgical site infection, re-admission, decubitus ulcer, pneumonia, deep vein thrombosis, pulmonary embolism, delirium, myocardial infarction, 90 days mortality
Time frame: 2 weeks, 6 weeks, and 3 months after treatment
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