Geriatric Lateral Compression 1 Pelvic Fractures

Study Overview
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Brief Summary
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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 transiliac - transsacral screw fixation to non-operative management in symptomatic LC1 fragility fractures in elderly patients.

Detailed Description
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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 transiliac-transsacral screw fixation, or a nonoperative group, defined as treatment with therapies and pain management only. Group 1-Operative treatment: Percutaneous screw fixation will be performed for stabilization of the pelvic fracture Group 2-Conservative (non-operative) treatment: Pain management and physical therapy advanced with weight bearing as tolerated.

Official Title
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Percutaneous Sacral Screw Fixation for Operative Treatment Versus Non-Operative Treatment of Geriatric Lateral Compression 1 Pelvic Fractures - A Randomized Controlled Trial

Conditions
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Lateral Compression 1 Pelvic Fracture

Intervention / Treatment
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* Procedure: Percutaneous transiliac - transsacral screw fixation
* Other: Pain management and physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >/= 60 years of age Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CT and/or MRI Low energy mechanism of injury or an insufficiency fracture without a precipitating event Acute injury within four weeks of presentation Inability or significant pain to mobilize with physical therapy assistance for 48 hours: Significant pain as determined by a pain score ≥ 7 with the Visual Analogue Scale (VAS) after a Timed Up & Go (TUG) assessment, or inability to complete the TUG assessment. Exclusion Criteria: Dementia Vertically or rotationally unstable pelvic ring injuries Pathologic fracture secondary to tumor Non-ambulatory prior to injury Acute neurologic deficit High-energy mechanism of injury Concomitant injuries affecting ambulation Presence of another injury or medical condition that prevents ambulation Presence of implant or sacral morphology that prevents percutaneous sacral fixation Enrollment in another research study the precludes co-enrollment Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.) Incarcerated or pending incarceration

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Operative<br>Percutaneous transiliac-transsacral screw fixation | Procedure: Percutaneous transiliac - transsacral screw fixation<br>* Surgical intervention in the form of percutaneous transiliac - transsacral screw fixation<br>|
| Experimental: Non-operative<br>Pain management and physical therapy advanced with weight bearing as tolerated. | Other: Pain management and physical therapy<br>* Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 our physical therapy team to get up from a chair, ambulate 3 meters turn around and sit down. | Day 2 after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 our physical therapy team to get up from a chair, ambulate 3 meters turn around and sit down. | 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) | 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 | Day 2 after treatment | 
| Use of Narcotic Pain Medication | Use of narcotic pain medication, total in milligram equivalents (MME) | Day 2 after treatment | 
| Hospital Length of Stay | Number of days admitted to hospital during treatment | 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 | 2 weeks, 6 weeks, and 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral compression, Operative, Non-operative, Fragility fracture, Pelvic fracture, Percutaneous pelvis screw, Osteoporosis