Back to resultsTreatment of Thoracolumbar Spine Fractures: Percutaneously Placed Pedicle Screws Versus Open Treatment
Primary Purpose
Thoracolumbar Spine Trauma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Pedicle Screw Fixation
Open Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Thoracolumbar Spine Trauma focused on measuring Randomized, Thoracolumbar fractures, Spine Trauma, Percutaneous Pedicle Screw Fixation, Functional Outcome
Eligibility Criteria
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.
Sites / Locations
- Allegheny General Hospital, Department or Orthopaedic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Percutaneous Pedicle Screw Fixation
Open Treatment
Arm Description
Percutaneous Pedicle Screw Fixation
Midline posterior incision with instrumentation.
Outcomes
Primary Outcome Measures
Change in Health Related Quality of Life Measure Scores
Oswestry Disability Index, Roland Morris Disability Score, Visual Analog Spine Score, Euroqol 5D-5L
Secondary Outcome Measures
Radiographic Evaluations
Kyphosis
Cost Effectiveness
Complication rate/Adverse event
Additional medical procedures
Any additional medical procedures outside of the index surgery.
Length of Hospital Stay
Estimated Blood Loss
Estimated blood loss, operating time, fluoroscopy time
Return to work
Radiographic Evaluation
Loss of height
Operating Time
The time it takes to complete the index surgery from start to finish.
Fluoroscopy time
Duration of time the fluoroscopy was in use during the index surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02146729
Brief Title
Treatment of Thoracolumbar Spine Fractures: Percutaneously Placed Pedicle Screws Versus Open Treatment
Official Title
Treatment of Thoracolumbar Spine Fractures: Percutaneously Placed Pedicle Screws Versus Open Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Research personnel changes prevented study initiation and enrollment
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Altman
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracolumbar Spine Trauma
Keywords
Randomized, Thoracolumbar fractures, Spine Trauma, Percutaneous Pedicle Screw Fixation, Functional Outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous Pedicle Screw Fixation
Arm Type
Experimental
Arm Description
Percutaneous Pedicle Screw Fixation
Arm Title
Open Treatment
Arm Type
Active Comparator
Arm Description
Midline posterior incision with instrumentation.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Pedicle Screw Fixation
Intervention Description
Percutaneous Pedicle Screw Fixation
Intervention Type
Procedure
Intervention Name(s)
Open Treatment
Intervention Description
Midline posterior incision with instrumentation.
Primary Outcome Measure Information:
Title
Change in Health Related Quality of Life Measure Scores
Description
Oswestry Disability Index, Roland Morris Disability Score, Visual Analog Spine Score, Euroqol 5D-5L
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Radiographic Evaluations
Description
Kyphosis
Time Frame
24 months
Title
Cost Effectiveness
Time Frame
Duration of Hospital Stay (expected duration average 1 week)
Title
Complication rate/Adverse event
Time Frame
24 months
Title
Additional medical procedures
Description
Any additional medical procedures outside of the index surgery.
Time Frame
24 months
Title
Length of Hospital Stay
Time Frame
Duration of hospital stay (expected duration average 1 week)
Title
Estimated Blood Loss
Description
Estimated blood loss, operating time, fluoroscopy time
Time Frame
Duration of hospital visit (expected duration- average 1 week)
Title
Return to work
Time Frame
24 months
Title
Radiographic Evaluation
Description
Loss of height
Time Frame
24 months
Title
Operating Time
Description
The time it takes to complete the index surgery from start to finish.
Time Frame
Duration of hospital visit (expected duration 1 week)
Title
Fluoroscopy time
Description
Duration of time the fluoroscopy was in use during the index surgery
Time Frame
Duration of hospital stay (expected duration average 1 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Allegheny General Hospital, Department or Orthopaedic Surgery
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Thoracolumbar Spine Fractures: Percutaneously Placed Pedicle Screws Versus Open Treatment
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