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

NCT ID: NCT02179697

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-06-30

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.

Conditions

Spinal Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery + Bracing vs. Bracing Alone

Randomize between 2 treatments:

Treatment 1: Surgery + Bracing Treatment 2: Bracing alone

Group Type: ACTIVE_COMPARATOR

Surgery + Bracing vs. Bracing Alone

Intervention Type: PROCEDURE

Surgery + Bracing vs. Bracing Alone

Patient's choice

Patient will decide which group is best for him/her. The patient will be followed at the same points as Group 1.

Group Type: OTHER

Patient's Choice

Intervention Type: OTHER

Patient chooses between surgery plus bracing or bracing alone. The patient will be followed according to the same schedule as Group 1.

Interventions

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.

Intervention Type: OTHER

Surgery + Bracing vs. Bracing Alone

Surgery + Bracing vs. Bracing Alone

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H Francis Farhadi

OTHER

Sponsor Role: lead

Responsible Party

H Francis Farhadi

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Francis Frahadi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State Unviersity

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2014H0100

Identifier Type: -

Identifier Source: org_study_id