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

Spinal Fractures Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02179697
• Other study ID #: 2014H0100
• Status: Withdrawn
• Phase: N/A
• First received: June 16, 2014
• Last updated: January 14, 2017
• Start date: August 2014
• Est. completion date: June 2018

Study information

• Verified date: January 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Spinal Fractures

Intervention

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.

Procedure:
• Surgery + Bracing vs. Bracing Alone
Surgery + Bracing vs. Bracing Alone

Locations

Country	Name	City	State
United States	The Ohio State Unviersity	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
H Francis Farhadi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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