RECRUITINGINTERVENTIONAL

Geriatric Lateral Compression 1 Pelvic Fractures

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

PROCEDURE

Percutaneous screw fixation

Surgical intervention in the form of percutaneous screw fixation

OTHER

Pain management

Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated

OTHER

Physical therapy

Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated

Locations (3)

Allina, Mercy Hospital

Coon Rapids, Minnesota, United States

Park Nicollet, Methodist Hospital

Saint Louis Park, Minnesota, United States

HealthPartners, Regions Hospital

Saint Paul, Minnesota, United States