Geriatric Lateral Compression 1 Pelvic Fractures

Last updated: September 23, 2024
Sponsor: HealthPartners Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

Percutaneous transiliac - transsacral screw fixation

Pain management and physical therapy

Physical therapy

Clinical Study ID

NCT05765669
A22-184
  • Ages 60-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients >/= 60 years of age

  • Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CTand/or MRI

  • Low energy mechanism of injury or an insufficiency fracture without a precipitatingevent

  • Acute injury within four weeks of presentation

  • Inability or significant pain to mobilize with physical therapy assistance for 48hours: Significant pain as determined by a pain score ≥ 7 with the Visual AnalogueScale (VAS) after a Timed "Up & Go" (TUG) assessment, or inability to complete theTUG assessment.

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 5
Primary Treatment: Percutaneous transiliac - transsacral screw fixation
Phase:
Study Start date:
May 05, 2023
Estimated Completion Date:
April 01, 2026

Study 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.

Connect with a study center

  • Allina, Mercy Hospital

    Coon Rapids, Minnesota 55433
    United States

    Active - Recruiting

  • Allina Health

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Park Nicollet, Methodist Hospital

    Saint Louis Park, Minnesota 55426
    United States

    Active - Recruiting

  • HealthPartners, Regions Hospital

    Saint Paul, Minnesota 55101
    United States

    Active - Recruiting

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