Geriatric Lateral Compression 1 Pelvic Fractures

HealthPartners Institute

Status: Enrolling

Conditions: Lateral Compression 1 Pelvic Fracture

Treatments: Other: Physical therapy; Procedure: Percutaneous screw fixation; Other: Pain management

Study type: Interventional

Funder types: Other

Identifiers

NCT05765669

A22-184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Operative

Experimental group

Description:

Percutaneous screw fixation

Treatment:

Procedure: Percutaneous screw fixation

Non-operative

Experimental group

Description:

Pain management and physical therapy advanced with weight bearing as tolerated.

Treatment:

Other: Pain management

Other: Physical therapy