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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02827214|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2016
Last Update Posted : August 13, 2020
|Condition or disease|
|Thoracolumbar Burst Fracture|
|Study Type :||Observational|
|Actual Enrollment :||213 participants|
|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|
Several surgical treatments exist to treat the fractures included in the study. The following section describes the different surgical treatment modalities in more detail
Non-surgical treatment is defined as bed rest followed by immobilization with:
- Oswestry Disability Index (ODI) [ Time Frame: 1 year ]ODI within the first year after surgical or non-surgical treatment using time to event analysis
- 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.
- 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.
- 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.
- 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.
- 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)
- 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.
- Surgical treatment failure rate [ Time Frame: 2 years ]Surgical treatment failure is defined as necessity of an additional surgery after the primary surgical treatment.
- 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
- 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.
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
|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|
|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|
|Alfred Health operating through the Alfred hospital|
|Melbourne, Australia, 3004|
|Hopital l'Enfant-Jesus, CHU de Quebec|
|Québec, Canada, 1401|
|Vancouver General Hospital|
|Vancouver, Canada, V5z1M9|
|Assiut University Hospitals|
|Assiut, Egypt, 71526|
|Kifisiá, Greece, 145 61|
|Coimbatore, India, 641011|
|Utrecht, Netherlands, 3508 AB|
|Clinical Hospital "Prof. N.Oblu"|
|Hospital Universitario Costa del Sol|
|Marbella, Spain, 29603|
|Inselspital, University of Bern|
|Bern, Switzerland, 3010|
|Principal Investigator:||Marcel Dvorak, MD||Vancouver General Hospital|