UnknownNot Applicable

Operative vs Non-Operative Treatment of Sacral Fractures

United States104 participantsStarted 2019-08

Plain-language summary

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.

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Timed Up and Go (TUG) Test

Timeframe: 2 weeks

Sacral Region Pain

Timeframe: 2 weeks

Trial details

NCT IDNCT04044300

SponsorMore Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12

Contact for this trial

Clifford B Jones, MD

623.241.8724 clifford.jones@thecoreinstitute.com

View on ClinicalTrials.gov More Sacral Fracture trials