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

NCT ID: NCT02146729

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-12-31

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).

Conditions

Thoracolumbar Spine Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous Pedicle Screw Fixation

Percutaneous Pedicle Screw Fixation

Group Type: EXPERIMENTAL

Percutaneous Pedicle Screw Fixation

Intervention Type: PROCEDURE

Percutaneous Pedicle Screw Fixation

Open Treatment

Midline posterior incision with instrumentation.

Group Type: ACTIVE_COMPARATOR

Open Treatment

Intervention Type: PROCEDURE

Midline posterior incision with instrumentation.

Interventions

Percutaneous Pedicle Screw Fixation

Percutaneous Pedicle Screw Fixation

Intervention Type: PROCEDURE

Open Treatment

Midline posterior incision with instrumentation.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daniel Altman

OTHER

Sponsor Role: lead

Responsible Party

Daniel Altman

Orthopaedic Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Allegheny General Hospital, Department or Orthopaedic Surgery

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

RC 5903

Identifier Type: -

Identifier Source: org_study_id