Randomized Trial With an Observational Component of Non-operative Versus Operative Treatment for AO Type A3 Fractures

Withdrawn before enrolling · Not applicable

Conditions studied: Spinal Fractures

In brief

The purpose of this study is to compare surgery plus bracing versus bracing alone. Both groups are considered standard of care treatments. The goal of this study is to determine which group is a better treatment.

Key facts

Study ID

NCT02179697

Run by

H Francis Farhadi

People needed

0

Starts

2014-08-01

Expected to finish

2018-06-01

Last updated by the study team

2017-01-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-65 years
• Acute trauma patient with AO Type A3.1-A3.3 fractures of T10-L2
• Neurologically intact
• TLICS score of 4
• Women of childbearing potential must have a negative serum pregnancy test

You may not qualify if…

• Severe poly-trauma (Injury Severity Score >15 and/or intubation required for > 24 hours)
• Sepsis and/or organ failure
• Prior instrumented arthrodesis of the thoracolumbar spine
• Severe co-morbidities (e.g., heart, respiratory, or renal disease)
• Recent history (<3 years) of concomitant spinal tumor or infection
• Greater than single level fracture involvement (other than transverse process fractures)
• AO Type A3 fracture with associated load sharing score ≥7
• ≥ 30 degrees regional kyphosis on standing
• History of autoimmune (seronegative) spondyloarthropathy (i.e., ankylosing spondylitis)
• History of osteoporosis
• Subjects who are pregnant or plan to become pregnant in the next 24 months. Patients will be advised on the use of contraceptives during this time. Methods include abstinence or two acceptable forms including condoms with spermicide, birth control pills, injections, or an IUD.
• Co-morbidity requiring medication that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, NSAIDs immunosuppressive agents, methotrexate)
• Severe morbid obesity (BMI > 40)
• History of metal sensitivity/foreign body sensitivity
• History of prior laminectomy at the fracture site
• Associated scoliotic (> 10°) or pre-existing thoracolumbar kyphotic deformity
• History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
• Prisoner

Where it is running

• The Ohio State Unviersity — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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