Clinical trial NCT02146729: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Thoracolumbar Spine Trauma
Keywords: Randomized
Thoracolumbar fractures
Spine Trauma
Percutaneous Pedicle Screw Fixation
Functional Outcome
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change in Health Related Quality of Life Measure Scores
timeFrame: 24 months
Secondary outcomes:
measure: Radiographic Evaluations
timeFrame: 24 months
measure: Cost Effectiveness
timeFrame: Duration of Hospital Stay (expected duration average 1 week)
measure: Complication rate/Adverse event
timeFrame: 24 months
measure: Additional medical procedures
timeFrame: 24 months
measure: Length of Hospital Stay
timeFrame: Duration of hospital stay (expected duration average 1 week)
measure: Estimated Blood Loss
timeFrame: Duration of hospital visit (expected duration- average 1 week)
measure: Return to work
timeFrame: 24 months
measure: Radiographic Evaluation
timeFrame: 24 months
measure: Operating Time
timeFrame: Duration of hospital visit (expected duration 1 week)
measure: Fluoroscopy time
timeFrame: Duration of hospital stay (expected duration average 1 week)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital, Department or Orthopaedic Surgery
state: Pennsylvania
Study officials:
References: