Operative vs Non-Operative Treatment of Sacral Fractures

Status unconfirmed · Not applicable

Conditions studied: Sacral Fracture

In brief

The purpose of this study is to compare percutaneous trans-iliac trans-sacral screw fixation to non-operative management for the treatment of symptomatic, sacral fragility fractures in elderly patients.

Key facts

Study ID

NCT04044300

Run by

More Foundation

People needed

104

Starts

2019-08-01

Expected to finish

2021-12-01

Last updated by the study team

2019-08-05

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients ≥ 60 years of age
• Pelvic ring fractures classified as LC1 or sacral U, confirmed with plain radiographs, CT and/or MRI
• Fracture is the result of a low energy mechanism of injury or an insufficiency fracture without a precipitating event
• Onset of symptoms within four weeks of presentation to hospital
• Significant pain or disability determined by:
• Reported pain score ≥ 7 using the Visual Analogue Score (VAS) after a Timed "Up \& Go" (TUG) test, or
• Inability to complete the TUG test
• Inability to get out of bed secondary to pain for 2 consecutive days

You may not qualify if…

• 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 lower extremity fractures affecting ambulation
• Presence of another injury or medical condition that prevents ambulation
• Presence of hardware or sacral morphology that prevents percutaneous sacral fixation
• Enrollment in another research study that precludes co-enrollment
• Inability to speak English
• Dementia with inability to answer questions and participate in study
• Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)
• Incarcerated or pending incarceration

Where it is running

• The CORE Institute — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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