Status:
UNKNOWN
Operative vs Non-Operative Treatment of Sacral Fractures
Lead Sponsor:
More Foundation
Collaborating Sponsors:
Orthopaedic Trauma Association
Conditions:
Sacral Fracture
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 patient...
Detailed Description
Sacral fragility fractures cause significant pain and morbidity in the elderly population in which they occur. These low-energy pelvic injuries can cause prolonged immobility, long hospital stays, and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04044300
Start Date
August 1 2019
End Date
December 1 2021
Last Update
August 5 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The CORE Institute
Phoenix, Arizona, United States, 85023