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Clinical Trial 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 transiliac - transsacral screw fixation to non-operative management in symptomatic LC1 fragility fractures in elderly patients.


Clinical Trial 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 transiliac-transsacral screw fixation, or a nonoperative group, defined as treatment with therapies 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 Design


Related Conditions & MeSH terms


NCT number NCT05765669
Study type Interventional
Source HealthPartners Institute
Contact Mai P Nguyen, MD
Phone 651-254-3669
Email mai.p.nguyen@healthpartners.com
Status Recruiting
Phase N/A
Start date May 5, 2023
Completion date April 1, 2026