Clinical trial NCT02179697: Randomized Trial With an Observational Component of Non-operative Versus Operative Treatment for AO Type A3 Fractures
Official title: Radiographic and Clinical Outcomes Following Non-operative Versus Operative Treatment of AO Type A3 Fractures: A Prospective, Randomized Clinical Trial With an Observational Component
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Fractures
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.
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare radiologic outcomes using regional kyphosis and Evaluate clinical outcomes using questionnaires
timeFrame: 2 years
Secondary outcomes:
measure: Compare radiologic outcomes using regional kyphosis
timeFrame: 5 and 10 years
measure: Evaluate clinical outcomes using questionnaires
timeFrame: 5 and 10 years
measure: Compare global sagittal balance at 3 different time points
timeFrame: 2,5, and 10 years
measure: Collect data on patient in both groups for 10 years
timeFrame: 10 years
measure: Compare Return to work rates over a two year peiord
timeFrame: 3 month, 1 year, and 2 years
measure: Compare Health Care Cost between both groups over 10 years
timeFrame: 10 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State Unviersity
state: Ohio
Study officials:
affiliation: Ohio State University
name: Francis Frahadi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: