Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment

• ClinicalTrials.gov Identifier: NCT02827214
• Recruitment Status: Active, not recruiting
• First Posted: July 11, 2016
• Last Update Posted: August 13, 2020
• Sponsor: AO Clinical Investigation and Publishing Documentation
• Collaborator: AO Foundation, AO Spine
• Information provided by (Responsible Party): AO Innovation Translation Center ( AO Clinical Investigation and Publishing Documentation )

Study Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 213 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

Groups and Cohorts

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)

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, California

University of California, San Diego Medical Center

San Diego, California, United States, 92093

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, New York

SUNY Upstate

East Syracuse, New York, United States, 13057

United States, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

United States, West Virginia

West Virginia University

Morgantown, West Virginia, United States, 26506-9496

Australia

Alfred Health operating through the Alfred hospital

Melbourne, Australia, 3004

Canada

Hopital l'Enfant-Jesus, CHU de Quebec

Québec, Canada, 1401

Vancouver General Hospital

Vancouver, Canada, V5z1M9

Egypt

Assiut University Hospitals

Assiut, Egypt, 71526

Greece

KAT Hospital

Kifisiá, Greece, 145 61

India

Ganga Hospital

Coimbatore, India, 641011

Netherlands

UMC Utrecht

Utrecht, Netherlands, 3508 AB

Romania

Clinical Hospital "Prof. N.Oblu"

Iasi, Romania

Spain

Hospital Universitario Costa del Sol

Marbella, Spain, 29603

Switzerland

Inselspital, University of Bern

Bern, Switzerland, 3010

Sponsors and Collaborators

AO Clinical Investigation and Publishing Documentation

AO Foundation, AO Spine

Investigators

• Principal Investigator: Marcel Dvorak, MD; Vancouver General Hospital

More Information

Additional Information:

Sponsor's website 

• Responsible Party: AO Clinical Investigation and Publishing Documentation
• ClinicalTrials.gov Identifier: NCT02827214
• Other Study ID Numbers: Spine_TL-A3-A4
• First Posted: July 11, 2016
• Last Update Posted: August 13, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by AO Innovation Translation Center ( AO Clinical Investigation and Publishing Documentation ):

Thoracolumbar spine; Burst fractures; Conservative treatment; Surgical treatment; Thoracic or lumbar vertebrae

Additional relevant MeSH terms:

Fractures, Bone; Wounds and Injuries