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

NCT02179697 | Withdrawn DMC

• 1 other identifier: 2014H0100
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Compare radiologic outcomes using regional kyphosis

  5 and 10 years

• Evaluate clinical outcomes using questionnaires

  5 and 10 years

• Compare global sagittal balance at 3 different time points

  2,5, and 10 years

• Collect data on patient in both groups for 10 years

  10 years

• Compare Return to work rates over a two year peiord

  3 month, 1 year, and 2 years

Study Arms (2)

Surgery + Bracing vs. Bracing Alone

ACTIVE COMPARATOR

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

Procedure: Surgery + Bracing vs. Bracing Alone

Patient's choice

OTHER

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

Interventions

Patient's Choice OTHER

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

Patient's choice

Surgery + Bracing vs. Bracing Alone PROCEDURE

Surgery + Bracing vs. Bracing Alone

Surgery + Bracing vs. Bracing Alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H Francis Farhadi: lead

Study Sites (1)

The Ohio State Unviersity

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Spinal Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Francis Frahadi, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: July 2, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)