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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery + Bracing vs. Bracing Alone | Active Comparator | Randomize between 2 treatments: Treatment 1: Surgery + Bracing Treatment 2: Bracing alone |
|
| Patient's choice | Other | Patient will decide which group is best for him/her. The patient will be followed at the same points as Group 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient's Choice | Other | Patient chooses between surgery plus bracing or bracing alone. The patient will be followed according to the same schedule as Group 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 and 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis Frahadi, MD, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State Unviersity | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Surgery + Bracing vs. Bracing Alone | Procedure | Surgery + Bracing vs. Bracing Alone |
|
| 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. |
| 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. | 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. | 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. | 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. | 10 years |