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

Not Applicable

Withdrawn

• Conditions: Thoracolumbar Spine Trauma
• Interventions: Procedure: Open Treatment; Procedure: Percutaneous Pedicle Screw Fixation

• Registration Number: NCT02146729
• Lead Sponsor: Daniel Altman

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-26
• Study Start: 2014-07
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Treatment	Open Treatment	Midline posterior incision with instrumentation.
Percutaneous Pedicle Screw Fixation	Percutaneous Pedicle Screw Fixation	Percutaneous Pedicle Screw Fixation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Allegheny General Hospital, Department or Orthopaedic Surgery; 🇺🇸 Pittsburgh, Pennsylvania, United States