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.
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
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.
- Conditions
- Lumbar Vertebral Fracture
- 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 group | Role | What they receive |
|---|---|---|
| Percutaneous Screw Fixation | Patients who have had a Percutaneous Screw fixation procedure. Receives: Procedure: Thoracolumbar Fracture Fixation | |
| Open Fixation | Patients 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.
Rate of Positive and Negative Clinical Outcomes based on hospital adverse events
Hospital Adverse Events
Measured: 2000-2017
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.
- First posted31 Jul 2020
- Study start23 Apr 2018
- Primary completion19 Sep 2019
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Vertebral FractureStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Salah Aoun, University of Texas Southwestern Medical Center
- Investigators
- Salah Aoun, MD, Principal investigator, University of Texas Southwestern Medical Center
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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Screw Fixation vs. Open Fixation in the Treatment of Thoracolumbar Fractures
- ClinicalTrials.gov ID
- NCT04495400
- Acronym / sponsor ID
- PrecScrew / STU 042018-004
- Conditions
- Lumbar Vertebral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Screw Fixation | – | Procedure: Thoracolumbar Fracture FixationPatients who have had a Percutaneous Screw fixation procedure. |
| Open Fixation | – | Procedure: Thoracolumbar Fracture FixationPatients who have had an Open Fixation procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- Who underwent open surgical fixation at Parkland Hospital
- Who underwent percutaneous (minimally invasive) screw fixation at Parkland Hospital • Age above 18 years
Key exclusion criteria (3 listed)
- Age below 18
- Bleeding disorders
- Prior surgical fixation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracolumbar Fracture FixationThe 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. | Procedure or surgery | Open Fixation, Percutaneous Screw Fixation |
Primary outcome
Rate of Positive and Negative Clinical Outcomes based on hospital adverse events
Time frame: 2000-2017
Hospital Adverse Events
Rate of positive and negative radiographic outcomes based on cobb angle of kyphosis and vertebral wedge angle
Time frame: 2000-2017
Curvature of spine post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No. No IPD will be shared.
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Large-Scale Evaluation of a Clinical Decision Tree for the Management of Low-Energy Thoracic and Lumbar Vertebral Compression Fractures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Aoun, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
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.