NCT05765669

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lateral Compression 1 Pelvic Fracture

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-05
• Primary completion: 2026-06-01
• Completion: 2026-09-30
• First posted: 2023-03-13
• Last updated: 2025-06-13

Locations

3 sites across 1 country: United States