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Sponsor study identifier
observational
213
10 countries
14
Study Start
October 2016
Actual (reported)Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 23, 2016
Actual (reported)July 11, 2016
Actual (reported)October 2016
Actual (reported)December 31, 2021
Actual (reported)December 31, 2021
Actual (reported)Oswestry Disability Index (ODI)
ODI within the first year after surgical or non-surgical treatment using time to event analysis
1 year
AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost)
2 years
Quality of life EQ5D-3L
2 years
Numeric Pain Rating Scale (NPRS)
2 years
Spine Adverse Events Severity System (SAVES)
2 years
overall satisfaction with the treatment
2 years
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 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)
Patients with thoracolumbar burst fractures
University of California, San Diego Medical Center
San Diego, California, 92093, United States
SUNY Upstate
East Syracuse, New York, 13057, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
West Virginia University
Morgantown, West Virginia, 26506-9496, United States
Alfred Health operating through the Alfred hospital
Melbourne, 3004, Australia
Hopital l'Enfant-Jesus, CHU de Quebec
Québec, 1401, Canada
Vancouver General Hospital
Vancouver, V5z1M9, Canada
Canseco JA, Reinhold M, Dalton J, Dandurand C, Oner CF, Dvorak M, Wee Tee J, El-Sharkawi M, Vaccaro AR, Cezar Popescu E, Rajasekaran S, Benneker LM, Bransford RJ, Joaquim AF, Chhabra HS, Spiegl UJA, Hauri D, Schnake KJ, Bigdon SF, France JC, Paquet J, Allen RT, Lavelle W, Hirschfield M, Pneumaticos S, Schroeder GD. Acute thoracolumbar burst fractures (AO types A3/A4) with and without concomitant posterior ligamentous complex injury: treatment outcomes in surgically and nonsurgically managed patients. A multi-center prospective study. Eur Spine J. 2026 Jul;35(7):4420-4437. doi: 10.1007/s00586-025-09680-5. Epub 2026 Mar 19.
Marcel Dvorak, MD
Vancouver General Hospital
213 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2016
First Posted
July 11, 2016
Study Start
October 2016
Actual (reported)Contact the study team to confirm eligibility.
Assiut University Hospitals
Asyut, 71526, Egypt
KAT Hospital
Kifissia, 145 61, Greece
Ganga Hospital
Coimbatore, 641011, India
UMC Utrecht
Utrecht, 3508 AB, Netherlands
Clinical Hospital "Prof. N.Oblu"
Iași, Romania
Hospital Universitario Costa del Sol
Marbella, 29603, Spain
Inselspital, University of Bern
Bern, 3010, Switzerland
Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)Last Updated
January 31, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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