Lateral Compression 1 Pelvic Fracture
Conditions
Keywords
Lateral compression, Operative, Non-operative, Fragility fracture, Pelvic fracture, Percutaneous pelvis screw, Osteoporosis
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPercutaneous screw fixation
Surgical intervention in the form of percutaneous screw fixation
OTHERPain management
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
OTHERPhysical therapy
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Sponsors
HealthPartners Institute
Orthopaedic Trauma Association
Allina Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) assessment | Day 2 after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sacral Region Pain by Visual Analog Scale | Day 2, 2 weeks, 6 weeks, and 3 months after treatment | Patient reported pain on a scale of 0-10. Minimum score 0 (no pain) to maximum score 10 (worst possible pain) |
| Timed Up and Go (TUG) assessment | 2 weeks, 6 weeks, and 3 months after treatment | 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. |
| Discharge Disposition Location | Post discharge from treatment, an average of 5 days from being admitted to the hospital | Where a patient went after being discharged from the hospital (home, rehabilitation center, skilled nursing facility) |
| Longest Distance of Ambulation | Day 2 after treatment | How far a patient was able to walk |
| Use of Narcotic Pain Medication | Day 2 after treatment | Use of narcotic pain medication, total in milligram equivalents (MME) |
| Hospital Length of Stay | Post discharge from treatment, an average of 5 days from being admitted to the hospital | Number of days admitted to hospital during treatment |
| Rate of Complications | 2 weeks, 6 weeks, and 3 months after treatment | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMai P. Nguyen, MD
University of Minnesota and HealthPartners
Outcome results
None listed