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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Spinal Fractures

Intervention / Treatment
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* Other: Patient's Choice
* Procedure: Surgery + Bracing vs. Bracing Alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years Acute trauma patient with AO Type A3.1-A3.3 fractures of T10-L2 Neurologically intact TLICS score of 4 Women of childbearing potential must have a negative serum pregnancy test Exclusion Criteria: Severe poly-trauma (Injury Severity Score >15 and/or intubation required for > 24 hours) Sepsis and/or organ failure Prior instrumented arthrodesis of the thoracolumbar spine Severe co-morbidities (e.g., heart, respiratory, or renal disease) Recent history (<3 years) of concomitant spinal tumor or infection Greater than single level fracture involvement (other than transverse process fractures) AO Type A3 fracture with associated load sharing score ≥7 ≥ 30 degrees regional kyphosis on standing History of autoimmune (seronegative) spondyloarthropathy (i.e., ankylosing spondylitis) History of osteoporosis 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. Co-morbidity requiring medication that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, NSAIDs immunosuppressive agents, methotrexate) Severe morbid obesity (BMI > 40) History of metal sensitivity/foreign body sensitivity History of prior laminectomy at the fracture site Associated scoliotic (> 10°) or pre-existing thoracolumbar kyphotic deformity 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 Prisoner

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery + Bracing vs. Bracing Alone<br>Randomize between 2 treatments: Treatment 1: Surgery + Bracing Treatment 2: Bracing alone | Procedure: Surgery + Bracing vs. Bracing Alone<br>* Surgery + Bracing vs. Bracing Alone<br>|
| Other: Patient's choice<br>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<br>* Patient chooses between surgery plus bracing or bracing alone. The patient will be followed according to the same schedule as Group 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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.