Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment

January 6, 2023 updated by: AO Innovation Translation Center

Thoracolumbar Burst Fractures (AOSpine A3, A4) in Neurologically Intact Patients: An Observational, Multicenter Cohort Study Comparing Surgical Versus Non-surgical Treatment

Thoracolumbar (TL) burst fractures in neurologically intact patients account for approximately 45% of all TL spine injuries. Despite being common fractures, there is significant variability in treatment recommendations encompassing surgery and non-surgical treatment options. The controversy regarding optimal treatment for these injuries is fueled by several studies which suggest a potential benefit to surgical treatment in the realm of patient satisfaction, and the overall socio-economic burden of treatment while other studies demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study aims to perform a prospective cohort analysis investigating the clinical outcome of various treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A cost-effectiveness analysis will also be performed to identify costs and benefits of each treatment option. More specifically a sub-group analysis will be performed for this group of patients, which have equipoise in regards to patients treatment, as decided by a blinded review panel.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

208 subjects (i.e., 137 per surgical group; 71 per conservative group) with TL burst fractures AOSpine classification type A3 or A4 without neurological deficit as defined in the inclusion/exclusion criteria, and with or without suspected Posterior Ligament Complex (PLC) injury (M1) from T10 to L2, will be enrolled in a prospective multicenter cohort study. Patients may have an associated B injury, but must have an A3 or A4. Patients will be monitored prospectively for patient reported, clinical and radiologic outcomes, over a period of 2 years post-treatment. Specifically a patient diary will measure the Oswestry Disability Index (ODI), and employment information (indirect costs questionnaire) every second week until 6 months post-treatment. Diary will continue every second month until 2 years post-treatment. All interventions/examinations are considered as standard of care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3004
        • Alfred Health operating through the Alfred hospital
  • Canada
      • Québec, Canada, 1401
        • Hopital l'Enfant-Jesus, CHU de Quebec
      • Vancouver, Canada, V5Z1M9
        • Vancouver General Hospital
  • Egypt
      • Assiut, Egypt, 71526
        • Assiut University Hospitals
  • Greece
      • Kifisiá, Greece, 145 61
        • KAT Hospital
  • India
      • Coimbatore, India, 641011
        • Ganga Hospital
  • Netherlands
      • Utrecht, Netherlands, 3508 AB
        • UMC Utrecht
  • Romania
      • Iasi, Romania
        • Clinical Hospital "Prof. N.Oblu"
  • Spain
      • Marbella, Spain, 29603
        • Hospital Universitario Costa del Sol
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, University of Bern
  • United States
    • California
      • San Diego, California, United States, 92093
        • University of California, San Diego Medical Center
    • New York
      • East Syracuse, New York, United States, 13057
        • SUNY Upstate
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-9496
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with thoracolumbar burst fractures

Description

Inclusion Criteria:

  • Skeletally mature, age 18 to 65 years old inclusive
  • Diagnosis of AO type A3 or A4 fractures on a CT scan with or without a suspected PLC injury (M1) from T10 to L2.
  • Patients may have an associated B injury, but must have an A3 or A4.
  • TLICS Score between 2-5 inclusive
  • Acute fracture - diagnosis and treatment within 10 days of injury
  • Ability to understand the content of the patient information / informed consent form
  • Willingness and ability to participate in the clinical investigation including imaging and FU procedures
  • Investigation according to the Clinical Investigation Plan (CIP)
  • Signed and dated IRB/EC-approved written informed consent

Exclusion Criteria:

  • Any neurological deficit associated with the fracture. Absence of neurological deficit will be determined with the International Standards for Neurological Classification of Spinal Cord Injury (ISNC SCI). It will be documented the status "E" (neurologically intact/normal) of the patient.
  • Spontaneous fractures due to pathologic processes or neoplasia
  • Head injuries causing inability to cooperate during hospital admission
  • Open or penetrating spinal lesion (e.g. due to gun, stab, or projectile)
  • Prior spinal surgeries in thoracic or lumbar spine
  • Additional musculoskeletal, head or other injuries which would preclude rapid mobilization
  • Multiple trauma or Injury Severity Score (ISS) > 16
  • Other co-morbidities precluding the patient to be considered as a surgical or non-surgical candidate, i.e. burns, dementia, BMI > 40, etc.
  • Any severe systemic medical disease that would exclude the patient to be a potential candidate for surgery
  • Prisoner
  • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
  • Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment.
  • Pregnancy or women planning to conceive within the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Surgical treatment

Several surgical treatments exist to treat the fractures included in the study. The following section describes the different surgical treatment modalities in more detail

Approaches:

  • Open short segment surgical fixation (1 level above and below the fracture level) with or without posterior decompression
  • Open long segment posterior fixation (2 or more levels above, 2 or more levels below) with or without posterior decompression
  • Posterior short or long fixation with posterolateral corpectomy and reconstruction
  • Anterior alone instrumentation
  • Combined Anterior Posterior (AP) instrumentation
  • Percutaneous posterior fixation combined with anterior instrumentation
  • Percutaneous posterior fixation with or without vertebroplasty
Non-surgical treatment

Non-surgical treatment is defined as bed rest followed by immobilization with:

  • Custom-molded or prefabricated total body contact thoracolumbosacral orthosis (TLSO)
  • Thermoplastic removable brace
  • Jewett hyperextension braces
  • Anterior hyperextension brace (ASH)
  • Taylor-Knight brace
  • Plaster of Paris (POP)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: 1 year
ODI within the first year after surgical or non-surgical treatment using time to event analysis
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost)
Time Frame: 2 years
AOSpine PROST consists of 19 questions on aspects of functioning such as personal care, traveling, and emotional functioning after the accident causing the spinal injury. Each item has a 0-100 numeric rating scale, supported by smileys at both ends of the ruler. It is important to realize that 0 indicates a level at which the patient is non-functional and 100 indicates the level before the accident, no matter how well or poorly the patient functioned before the accident.
2 years
Quality of life EQ5D-3L
Time Frame: 2 years
The EuroQoL-5D (EQ-5D) is a standardized instrument that was designed for self-completion. It has five items (mobility, self-care, usual activities, pain / discomfort and anxiety / depression) with a three-point categorical response scale (1 = no problems, 2 = some / moderate problems, 3 = extreme problems) where the patient's current health status will be assessed.
2 years
Numeric Pain Rating Scale (NPRS)
Time Frame: 2 years
The NPRS measures the subjective intensity of pain. The patient is asked to make a pain rating, corresponding to his/her experienced pain.
2 years
Spine Adverse Events Severity System (SAVES)
Time Frame: 2 years
The SAVES is a prospective adverse event (AE) recording instrument. The AEs are defined as any unexpected or undesirable events occurring as a result of spinal surgery, and a complication as a disease or disorder, which, as a consequence of a surgical procedure, that will negatively affect the outcome of a patient.
2 years
overall satisfaction with the treatment
Time Frame: 2 years
The overall satisfaction with treatment questionnaire contents one question regarding the satisfaction with the results of the recent treatment of the spine injury with a rating system from extremely satisfied (1) to not sure/no opinion (8)
2 years
Non-surgical treatment failure rate
Time Frame: 2 years
Failure rate of conservative treatment will be assessed during this study. Non-surgical treatment failure is defined as necessity of surgery after non-surgical treatment.
2 years
Surgical treatment failure rate
Time Frame: 2 years
Surgical treatment failure is defined as necessity of an additional surgery after the primary surgical treatment.
2 years
indirect cost questionnaire
Time Frame: 2 years
The indirect cost questionnaire assesses the personal situation of the patient at his workplace regarding to health, support, and their financial income statement
2 years
Validation of AO TL Classification System aided by the analysis of CT scans
Time Frame: 2 years
The participating clinics will upload the clinical data (de-identified X-rays, CT, MRI images) on a secure web-based platform. AOSpine Knowledge Forum Trauma Steering committee members, blinded to the diagnosis made in the study, will analyze the different images to validate the different TL fractures type A3 or A4 with or without PLC injury according to the new AOSpine TL Classification System.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AO Innovation Translation Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AO Foundation, AO Spine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcel Dvorak, MD, Vancouver General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Spine_TL-A3-A4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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