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Research personnel changes prevented study initiation and enrollment
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Pedicle Screw Fixation | Experimental | Percutaneous Pedicle Screw Fixation |
|
| Open Treatment | Active Comparator | Midline posterior incision with instrumentation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Pedicle Screw Fixation | Procedure | Percutaneous Pedicle Screw Fixation |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Evaluations | Kyphosis | 24 months |
| Cost Effectiveness | Duration of Hospital Stay (expected duration average 1 week) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegheny General Hospital, Department or Orthopaedic Surgery | Pittsburgh | Pennsylvania | 15212 | United States |
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| ID | Term |
|---|---|
| D000080872 | Open Abdomen Techniques |
| ID | Term |
|---|---|
| D058107 | Abdominal Wound Closure Techniques |
| D058106 | Wound Closure Techniques |
| D013514 | Surgical Procedures, Operative |
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| Open Treatment | Procedure | Midline posterior incision with instrumentation. |
|
| 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) |