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

Spinal Fractures Clinical Trial

Official title:
Radiographic and Clinical Outcomes Following Non-operative Versus Operative Treatment of AO Type A3 Fractures: A Prospective, Randomized Clinical Trial With an Observational Component

Clinical Trial Summary

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.

Clinical Trial Description

Patient must be between 18 and 65 years old and had an acute trauma with an AO type A3 burst fracture (a spinal injury where one of the bony parts of the spine [vertebra] breaks due to immediate and severe compression).

The purpose of this study is to compare surgery plus bracing versus bracing alone. Patients will be followed for 10 years. The investigators will compare patients' x-ray outcomes and clinical outcomes (i.e. how a patient is feeling and how a patient is able to do usual daily activities) as well as patients' immediate and delayed medical and surgical side effects between the 2 study arms. The goal of this study is to determine if treating patients with surgery plus bracing is better than just bracing alone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02179697
Study type Interventional
Source Ohio State University
Contact
Status Withdrawn
Phase N/A
Start date August 2014
Completion date June 2018
View Details
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