An interventional study of Patient's Choice and Surgery + Bracing vs. Bracing Alone in Spinal Fractures, sponsored by H Francis Farhadi. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-18.
Sponsored by H Francis Farhadi · Not applicable, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
Browse Fractures, Bone studies →This is the only study on the registry with H Francis Farhadi as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Randomize between 2 treatments: Treatment 1: Surgery + Bracing Treatment 2: Bracing alone
Procedure: Surgery + Bracing vs. Bracing Alone
Patient will decide which group is best for him/her. The patient will be followed at the same points as Group 1.
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.
Surgery + Bracing vs. Bracing Alone
Compare radiologic outcomes using regional kyphosis and Evaluate clinical outcomes using questionnaires
Primary Outcome is to compare radiologic and clinical outcomes. These will be measured by regional kyphosis, at 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients; and Oswestry Disability Index, at 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients.
Time frame: 2 years
Compare radiologic outcomes using regional kyphosis
Secondary outcome is to compare radiologic outcomes, as measured by regional kyphosis, at 5 and 10 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients
Time frame: 5 and 10 years
Evaluate clinical outcomes using questionnaires
Secondary outcome is to evaluate clinical outcomes, as measured by the Oswestry Disability Index, at 5 and 10 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients.
Time frame: 5 and 10 years
Compare global sagittal balance at 3 different time points
Secondary Outcome is to compare global sagittal balance at 2, 5, and 10 years.
Time frame: 2,5, and 10 years
Collect data on patient in both groups for 10 years
Secondary Outcome is to record frequency and time to secondary surgical intervention among patients in the bracing group.
Time frame: 10 years
Compare Return to work rates over a two year peiord
Secondary Outcome is to Compare return-to-work rates at 3 months, 1 year, and 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients.
Time frame: 3 month, 1 year, and 2 years
Compare Health Care Cost between both groups over 10 years
Secondary Outcome is to compare health care cost and utilization through extended follow-up period.
Time frame: 10 years
This study is withdrawn, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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