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

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).

Study Overview

• Status: Withdrawn
• Conditions: Thoracolumbar Spine Trauma
• Intervention / Treatment: Procedure: Percutaneous Pedicle Screw Fixation; Procedure: Open Treatment

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital, Department or Orthopaedic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous Pedicle Screw Fixation	Procedure: Percutaneous Pedicle Screw Fixation; Percutaneous Pedicle Screw Fixation
Active Comparator: Open Treatment; Midline posterior incision with instrumentation.	Procedure: Open Treatment; Midline posterior incision with instrumentation.

What is the study measuring?

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
Return to work		24 months
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)
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)

Collaborators and Investigators

• Sponsor: Daniel Altman

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 26, 2014

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Randomized; Functional Outcome; Thoracolumbar fractures; Spine Trauma; Percutaneous Pedicle Screw Fixation
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Spinal Injuries; Back Injuries; Spinal Fractures
• Other Study ID Numbers: RC 5903