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

NCT02146729 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-02-02

No results posted yet for this study

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).

Conditions

  • Thoracolumbar Spine Trauma

Interventions

PROCEDURE

Percutaneous Pedicle Screw Fixation

Percutaneous Pedicle Screw Fixation

PROCEDURE

Open Treatment

Midline posterior incision with instrumentation.

Sponsors & Collaborators

  • Daniel Altman

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02146729 on ClinicalTrials.gov