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Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02827214
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
AOSpine International
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Brief Summary:
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.

Condition or disease
Thoracolumbar Burst Fracture

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.

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Study Type : Observational
Estimated Enrollment : 208 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thoracolumbar Burst Fractures (AOSpine A3, A4) in Neurologically Intact Patients: An Observational, Multicenter Cohort Study Comparing Surgical Versus Non-surgical Treatment
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort
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)



Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 1 year ]
    ODI within the first year after surgical or non-surgical treatment using time to event analysis


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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.

  5. 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)

  6. 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.

  7. Surgical treatment failure rate [ Time Frame: 2 years ]
    Surgical treatment failure is defined as necessity of an additional surgery after the primary surgical treatment.

  8. 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

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with thoracolumbar burst fractures
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827214


Contacts
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Contact: Brigitte S. Gallo-Kopf, PhD +41 44 200 24 06 brigitte.gallo@aofoundation.org
Contact: Benjamin Weiss + 41 44 200 24 66 Benjamin.Weiss@aofoundation.org

Locations
Show Show 18 study locations
Sponsors and Collaborators
AO Clinical Investigation and Documentation
AOSpine International
Investigators
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Principal Investigator: Marcel Dvorak, MD Vancouver General Hospital

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Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT02827214    
Other Study ID Numbers: Spine_TL-A3-A4
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AO Clinical Investigation and Documentation:
Thoracolumbar spine
Burst fractures
Conservative treatment
Surgical treatment
Thoracic or lumbar vertebrae
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries