Back to results

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

Primary Purpose

Spinal Fractures

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Patient's Choice

Surgery + Bracing vs. Bracing Alone

About this trial

This is an interventional treatment trial for Spinal Fractures focused on measuring 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.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Ohio State Unviersity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Surgery + Bracing vs. Bracing Alone

Patient's choice

Arm Description

Randomize between 2 treatments: Treatment 1: Surgery + Bracing Treatment 2: Bracing alone

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Compare global sagittal balance at 3 different time points

Secondary Outcome is to compare global sagittal balance at 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.

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.

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.

Full Information

NCT ID

NCT02179697

First Posted

June 16, 2014

Last Updated

January 14, 2017

Sponsor

H Francis Farhadi

1. Study Identification

Unique Protocol Identification Number

NCT02179697

Brief Title

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

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Withdrawn

Study Start Date

August 2014 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

H Francis Farhadi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surgery + Bracing vs. Bracing Alone

Arm Type

Active Comparator

Arm Description

Randomize between 2 treatments: Treatment 1: Surgery + Bracing Treatment 2: Bracing alone

Arm Title

Patient's choice

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Patient's Choice

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Surgery + Bracing vs. Bracing Alone

Intervention Description

Surgery + Bracing vs. Bracing Alone

Primary Outcome Measure Information:

Title

Compare radiologic outcomes using regional kyphosis and Evaluate clinical outcomes using questionnaires

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Compare radiologic outcomes using regional kyphosis

Description

Time Frame

5 and 10 years

Title

Evaluate clinical outcomes using questionnaires

Description

Time Frame

5 and 10 years

Title

Compare global sagittal balance at 3 different time points

Description

Secondary Outcome is to compare global sagittal balance at 2, 5, and 10 years.

Time Frame

2,5, and 10 years

Title

Collect data on patient in both groups for 10 years

Description

Secondary Outcome is to record frequency and time to secondary surgical intervention among patients in the bracing group.

Time Frame

10 years

Title

Compare Return to work rates over a two year peiord

Description

Time Frame

3 month, 1 year, and 2 years

Title

Compare Health Care Cost between both groups over 10 years

Description

Secondary Outcome is to compare health care cost and utilization through extended follow-up period.

Time Frame

10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis Frahadi, MD, PhD

Organizational Affiliation

Ohio State University Wexner Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ohio State Unviersity

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs