Treatment of Thoracolumbar Spine Fractures: Percutaneously Placed Pedicle Screws Versus Open Treatment

Study Overview
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Brief Summary
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In patients presenting with Type A and Type B1, B2 thoracolumbar fractures, there is a lack of evidence demonstrating similar outcomes between patients treated with percutaneous pedicle screws and those treated openly. It has been demonstrated that percutaneous pedicle screw fixation has fared well for patients in the short term; however, it is unclear whether the outcomes are equivalent or inferior/superior compared to open treatment. The authors seek to establish a high-level evidence base to determine clinical patient outcomes, radiographic outcomes, as well as cost-effectiveness data in comparing thoracolumbar burst fracture patients treated with percutaneous pedicle screws, open treatment, and brace treatment. Additionally, the authors seek to establish data relating to patient occupational data, complications, and need for further surgery (revision/removal of hardware), as well as short-term variables relating to hospital visit (length of stay, estimated blood loss, time under fluoroscopy).

Official Title
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Treatment of Thoracolumbar Spine Fractures: Percutaneously Placed Pedicle Screws Versus Open Treatment

Conditions
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Thoracolumbar Spine Trauma

Intervention / Treatment
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* Procedure: Percutaneous Pedicle Screw Fixation
* Procedure: Open Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients from ages 18 and older who present to Allegheny General Hospital with an acute thoracolumbar fracture will be considered eligible for the study (i.e. <3 weeks from trauma date). Minor fractures around the fracture site or compression fractures will be permitted if they do not require treatment For the purposes of the study, patients must be English-speaking and live within the 100 mile radius from the greater Pittsburgh area for consent and follow-up purposes Patients who cannot safely undergo brace treatment due to comorbidities such as obesity, pulmonary injury, elderly status, reliability, and multitrauma Patients must have Type A or Type B1,B2 thoracolumbar fracture (must be able to correct deformity through percutaneous instrumentation) Exclusion Criteria: Patients presenting with a neurologic deficit Patients who receive a laminectomy for decompression of the neural elements Patients who have a significant head injury Oncologic patients Women who were found to be pregnant or breast feeding at any point during their admission, hospital stay, treatment, or clinical follow-up. Individuals who are currently incarcerated. Adolescents under 18 years of age. Patients who have a relative contraindication to operative treatment will be excluded - infection, skin disease, bleeding disorder, etc.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Pedicle Screw Fixation<br>Percutaneous Pedicle Screw Fixation | Procedure: Percutaneous Pedicle Screw Fixation<br>* Percutaneous Pedicle Screw Fixation<br>|
| Active Comparator: Open Treatment<br>Midline posterior incision with instrumentation. | Procedure: Open Treatment<br>* Midline posterior incision with instrumentation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Related Quality of Life Measure Scores | Oswestry Disability Index, Roland Morris Disability Score, Visual Analog Spine Score, Euroqol 5D-5L | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Evaluations | Kyphosis | 24 months | 
| Cost Effectiveness |  | Duration of Hospital Stay (expected duration average 1 week) | 
| Complication rate/Adverse event |  | 24 months | 
| Additional medical procedures | Any additional medical procedures outside of the index surgery. | 24 months | 
| Length of Hospital Stay |  | Duration of hospital stay (expected duration average 1 week) | 
| Estimated Blood Loss | Estimated blood loss, operating time, fluoroscopy time | Duration of hospital visit (expected duration- average 1 week) | 
| Return to work |  | 24 months | 
| Radiographic Evaluation | Loss of height | 24 months | 
| Operating Time | The time it takes to complete the index surgery from start to finish. | Duration of hospital visit (expected duration 1 week) | 
| Fluoroscopy time | Duration of time the fluoroscopy was in use during the index surgery | Duration of hospital stay (expected duration average 1 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized, Thoracolumbar fractures, Spine Trauma, Percutaneous Pedicle Screw Fixation, Functional Outcome