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Lumbar Vertebral FracturePrecScrewNCT04495400

Percutaneous Screw Fixation vs. Open Fixation in the Treatment of Thoracolumbar Fractures

An observational study of Lumbar Vertebral Fracture, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this single-center retrospective study, the investigators will include all patients admitted to Parkland Hospital who underwent surgical fixation of thoracolumbar fractures between the years 2000 and 2017. The study investigators will gather demographic, radiographic, and operative information. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lumbar Vertebral Fracture
What is being tested?
Thoracolumbar Fracture Fixation
Type of treatment
Surgery or procedure
How many people
485 participants
Where
1 siteUnited States
Study dates
23 Apr 2018to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients from 200 to 2017 who have either had a Percutaneous fixation or an open fixation for thoracolumbar fractures

Who may be able to join

  • Patients with thoracolumbar fractures:
  • Who underwent open surgical fixation at Parkland Hospital
  • Who underwent percutaneous (minimally invasive) screw fixation at Parkland Hospital • Age above 18 years

Who cannot join

  • Age below 18
  • Bleeding disorders
  • Prior surgical fixation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Parkland Health and Hospital System

    Dallas, Texas, 75390

Other trials in United States

About this study

In this single-center retrospective study, the investigators will include all patients admitted to Parkland Hospital who underwent surgical fixation of thoracolumbar fractures between the years 2000 and 2017. The study investigators will gather demographic, radiographic, and operative information. Patients will be matched according to demographic information in a case-control style. The primary outcome of the study will be comparing the clinical and radiographic outcomes of two surgical techniques in order to establish the best treatment approach for this disease.

Read the detailed description

Thoracolumbar (TL) fractures occur in 8-15% of blunt trauma patients cared for in major trauma centers. These fractures can be devastating and commonly occur in patients who endure high-energy trauma (e.g. motor vehicle accidents). TL fractures occur mainly between T10 and L2. The "3 Column Model" attempts to identify criteria that can predict instability of TL fractures. This model divides the spine into anterior, middle, and posterior areas. Stability is dependent on the integrity of two out of three of the columns. Major spine injuries are those that involve mechanical or neurologic instability.

The four major types of injury include compression, burst, seat-belt, and fracture-dislocation. Compression fractures account for 50-70% of all TL fractures and usually consist of compression failure of the anterior column. Burst fractures comprise approximately 14% of all TL injuries. These injuries usually involve compression of both the anterior and posterior column. Seat-belt fractures (aka flexion-distraction fractures) account for 10% of TL injuries and occur most commonly in patients who are wearing only the lap belt (i.e. no chest belt) during motor vehicle trauma. These injuries typically involve compression of the anterior column with distraction failure of both the middle and posterior columns. Finally, the fracture-dislocation type fracture occurs with massive direct trauma to the back, causing failure of all three columns and translational injury.

Patients with TL fractures may present with TL spine pain, midline TL spine tenderness, TL spine bony deformity, or neurologic deficit. Oftentimes these patients were in high-velocity traumatic scenarios, including falls from heights, crush injuries, motor vehicle crashes with ejection, unenclosed vehicles (ex. motorcycles), or automobile versus pedestrian accidents. Diagnosis is confirmed via computed tomography (CT) imaging or plain radiographs. CT imaging is typically more accurate than plain radiographs but can be poor in certain subtypes of injury. MRI can be utilized to assess the integrity of the ligaments and surrounding soft tissues.

There is currently no universally accepted system for classifying the severity of TL fractures. One proposed system is the Thoracolumbar injury classification and severity score (TLICS). Points are awarded based on radiographic findings, neurologic status, and the integrity of posterior ligamentous complex. The final numeric score is used to guide treatment, with higher scores indicating need for surgery. Neurologic deficit favors surgery.

There is no clear consensus on the best treatment approach for TL fractures. For situations where conservative management is decided (i.e. surgery is not required or is contraindicated), patients are treated with recumbency and delayed ambulation in orthosis with serial radiographs to determine need for further intervention. The surgical management for more severe/unstable fractures usually involves posterior instrumentation with percutaneous or open pedicle screw fixation.3 While the traditional open pedicle screw fixation technique has demonstrated good radiologic and clinical outcomes, a minimally invasive percutaneous approach has been increasingly used in recent years. The minimally invasive technique potentially carries the advantage of less operative blood loss, shorter operative time, smaller incisions, potentially less postoperative pain, and overall shorter hospital stay. There are a few studies published in the literature, but more studies are needed to establish the treatment modality that is the most efficacious and safe for these patients.

At the University of Texas Southwestern (Parkland Hospital), the investigators evaluate and treat a large population of patients with TL fractures. Previous trials in the literature comparing open and percutaneous fixation of TL fractures have been series of ~100-200 patients. These studies have shown variable results, with many concluding similar outcome results for the two surgical techniques. The purpose of this study is to compare a larger number of patients (~500) who have undergone either surgical approach to determine the best technique in terms of clinical and radiographic outcomes. The investigators believe this study will provide neurosurgeons with invaluable information about the safety and efficacy of different treatment modalities for TL fractures in this patient population.

Being tested
Thoracolumbar Fracture Fixation
Medical subject headings
Spinal Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoracolumbar Fracture FixationProcedure or surgery

    The is surgery is preformed on patients who have had a blunt trauma fractures between the T10 and the L2. The surgical management for more severe/unstable fractures usually involves posterior instrumentation with percutaneous or open pedicle screw fixation. While the traditional open pedicle screw fixation technique has demonstrated good radiologic and clinical outcomes, a minimally invasive percutaneous approach has been increasingly used in recent years.

Study groups in NCT04495400
Study groupRoleWhat they receive
Percutaneous Screw FixationPatients who have had a Percutaneous Screw fixation procedure.
Receives: Procedure: Thoracolumbar Fracture Fixation
Open FixationPatients who have had an Open Fixation procedure.
Receives: Procedure: Thoracolumbar Fracture Fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Positive and Negative Clinical Outcomes based on hospital adverse events

    Hospital Adverse Events

    Measured: 2000-2017

  2. Rate of positive and negative radiographic outcomes based on cobb angle of kyphosis and vertebral wedge angle

    Curvature of spine post-surgery

    Measured: 2000-2017

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2020
  2. Study start23 Apr 2018
  3. Primary completion19 Sep 2019
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
485 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04495400
Sponsor's protocol ID
STU 042018-004
Acronym
PrecScrew
Status last verified
Feb 2023
First submitted
31 Mar 2020
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Vertebral Fracture, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Positive and Negative Clinical Outcomes based on hospital adverse events (time frame: 2000-2017). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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