Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment

Completed

Conditions studied: Thoracolumbar Burst Fracture

In brief

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.

Key facts

Study ID

NCT02827214

Run by

AO Innovation Translation Center

People needed

213

Starts

2016-10-01

Expected to finish

2021-12-31

Last updated by the study team

2023-01-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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