Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment

NCT ID: NCT02827214

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 213 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Thoracolumbar Burst Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Foundation, AO Spine

OTHER

Sponsor Role: collaborator

AO Innovation Translation Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcel Dvorak, MD

Role: PRINCIPAL_INVESTIGATOR

Vancouver General Hospital

Locations

University of California, San Diego Medical Center

San Diego, California, United States

SUNY Upstate

East Syracuse, New York, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

West Virginia University

Morgantown, West Virginia, United States

Alfred Health operating through the Alfred hospital

Melbourne, , Australia

Hopital l'Enfant-Jesus, CHU de Quebec

Québec, , Canada

Vancouver General Hospital

Vancouver, , Canada

Assiut University Hospitals

Asyut, , Egypt

KAT Hospital

Kifissia, , Greece

Ganga Hospital

Coimbatore, , India

UMC Utrecht

Utrecht, , Netherlands

Clinical Hospital "Prof. N.Oblu"

Iași, , Romania

Hospital Universitario Costa del Sol

Marbella, , Spain

Inselspital, University of Bern

Bern, , Switzerland

Countries

United States; Australia; Canada; Egypt; Greece; India; Netherlands; Romania; Spain; Switzerland

Related Links

https://www.aofoundation.org

Sponsor's website

Other Identifiers

Spine_TL-A3-A4

Identifier Type: -

Identifier Source: org_study_id