Spinal Fractures
Conditions
Keywords
Groups:, Group 1 (2 Treatment Arms (Randomized between 2 treatments)), Treatment 1: Surgery + Bracing, Treatment 2: Bracing Alone, Group 2, The patient will decide which group is best for themselves.
Brief 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.
Interventions
OTHERPatient's Choice
Patient chooses between surgery plus bracing or bracing alone. The patient will be followed according to the same schedule as Group 1.
PROCEDURESurgery + Bracing vs. Bracing Alone
Surgery + Bracing vs. Bracing Alone
Sponsors
H Francis Farhadi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 years 2. Acute trauma patient with AO Type A3.1-A3.3 fractures of T10-L2 3. Neurologically intact 4. TLICS score of 4 5. Women of childbearing potential must have a negative serum pregnancy test
Exclusion criteria
1. Severe poly-trauma (Injury Severity Score \>15 and/or intubation required for \> 24 hours) 2. Sepsis and/or organ failure 3. Prior instrumented arthrodesis of the thoracolumbar spine 4. Severe co-morbidities (e.g., heart, respiratory, or renal disease) 5. Recent history (\<3 years) of concomitant spinal tumor or infection 6. Greater than single level fracture involvement (other than transverse process fractures) 7. AO Type A3 fracture with associated load sharing score ≥7 8. ≥ 30 degrees regional kyphosis on standing 9. History of autoimmune (seronegative) spondyloarthropathy (i.e., ankylosing spondylitis) 10. History of osteoporosis 11. 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. 12. Co-morbidity requiring medication that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, NSAIDs immunosuppressive agents, methotrexate) 13. Severe morbid obesity (BMI \> 40) 14. History of metal sensitivity/foreign body sensitivity 15. History of prior laminectomy at the fracture site 16. Associated scoliotic (\> 10°) or pre-existing thoracolumbar kyphotic deformity 17. 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 18. Prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare radiologic outcomes using regional kyphosis and Evaluate clinical outcomes using questionnaires | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Health Care Cost between both groups over 10 years | 10 years | Secondary Outcome is to compare health care cost and utilization through extended follow-up period. |
| Compare radiologic outcomes using regional kyphosis | 5 and 10 years | 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 |
| Compare Return to work rates over a two year peiord | 3 month, 1 year, and 2 years | 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. |
| Compare global sagittal balance at 3 different time points | 2,5, and 10 years | Secondary Outcome is to compare global sagittal balance at 2, 5, and 10 years. |
| Collect data on patient in both groups for 10 years | 10 years | Secondary Outcome is to record frequency and time to secondary surgical intervention among patients in the bracing group. |
| Evaluate clinical outcomes using questionnaires | 5 and 10 years | 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. |
Countries
United States
Outcome results
None listed