NCT02179697

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: H Francis Farhadi · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Spinal Fractures

Interventions

Type	Name	Description
OTHER	Patient's Choice	Patient chooses between surgery plus bracing or bracing alone. The patient will be followed according to the same schedule as Group 1.
PROCEDURE	Surgery + Bracing vs. Bracing Alone	Surgery + Bracing vs. Bracing Alone

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-06-01
• Completion: 2018-06-01
• First posted: 2014-07-02
• Last updated: 2017-01-18

Locations

1 site across 1 country: United States