Thoracolumbar Spine TraumaNCT02146729

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

A study testing Percutaneous Pedicle Screw Fixation and Open Treatment in people with Thoracolumbar Spine Trauma, run by Daniel Altman at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Thoracolumbar Spine Trauma
What is being tested?: Percutaneous Pedicle Screw Fixation and Open Treatment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Jul 2014to Dec 2016
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Allegheny General Hospital, Department or Orthopaedic Surgery
Pittsburgh, Pennsylvania, 15212

Other trials in United States

About this study

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
Being tested: Percutaneous Pedicle Screw Fixation, Open Treatment
Keywords: Randomized, Thoracolumbar fractures, Spine Trauma, Percutaneous Pedicle Screw Fixation, Functional Outcome

What participants receive

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

Percutaneous Pedicle Screw FixationProcedure or surgery
Percutaneous Pedicle Screw Fixation
Open TreatmentProcedure or surgery
Midline posterior incision with instrumentation.

Study groups in NCT02146729
Study group	Role	What they receive
Percutaneous Pedicle Screw Fixation	Experimental	Percutaneous Pedicle Screw Fixation Receives: Procedure: Percutaneous Pedicle Screw Fixation
Open Treatment	Active comparator	Midline posterior incision with instrumentation. Receives: Procedure: Open Treatment

What is being measured

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

Change in Health Related Quality of Life Measure Scores
Oswestry Disability Index, Roland Morris Disability Score, Visual Analog Spine Score, Euroqol 5D-5L
Measured: 24 months

Secondary outcomes (10)

Radiographic Evaluations
Kyphosis
Measured: 24 months
Cost Effectiveness
Measured: Duration of Hospital Stay (expected duration average 1 week)
Complication rate/Adverse event
Measured: 24 months
Additional medical procedures
Any additional medical procedures outside of the index surgery.
Measured: 24 months
Length of Hospital Stay
Measured: Duration of hospital stay (expected duration average 1 week)
Estimated Blood Loss
Estimated blood loss, operating time, fluoroscopy time
Measured: Duration of hospital visit (expected duration- average 1 week)
Return to work
Measured: 24 months
Radiographic Evaluation
Loss of height
Measured: 24 months
Operating Time
The time it takes to complete the index surgery from start to finish.
Measured: Duration of hospital visit (expected duration 1 week)
Fluoroscopy time
Duration of time the fluoroscopy was in use during the index surgery
Measured: Duration of hospital stay (expected duration average 1 week)

Timeline

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

Jul 2014Dec 2016

First posted26 May 2014 (estimated)
Study startJul 2014
Primary completionDec 2016
Study completionDec 2016

Why it stopped: Research personnel changes prevented study initiation and enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Thoracolumbar Spine TraumaStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02146729
Sponsor's protocol ID: RC 5903
Status last verified: Feb 2017
First submitted: 15 May 2014
Last updated: 2 Feb 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Controlled Reduction of AO Spine B3 Fractures in Ankylosing Spinal Disorders Using an Inflatable Positioning Device: Technical Note and Retrospective Single-centre Case Series
Spine Fracture, Osteoporosis
Recruiting
Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture
SPINAL Fracture, Burst Fracture
Recruiting
Three Dimensional Gait Analysis and Electromyography After Stabilisation of Thoracolumbar Spine Fractures Focusing on Possible Temporal Diferences in Physiological Gait Recovery Through Comparison of Open and Minimally Invasive Approaches.
Spine Fracture
Recruiting
ORthosis vs No Orthosis After Surgically Treated Traumatic Thoracolumbar Fractures
Spine Fracture, Orthosis

All Thoracolumbar Spine Trauma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Thoracolumbar Spine Fractures: Percutaneously Placed Pedicle Screws Versus Open Treatment
ClinicalTrials.gov ID: NCT02146729
Acronym / sponsor ID: RC 5903
Conditions: Thoracolumbar Spine Trauma
Keywords: Randomized, Thoracolumbar fractures, Spine Trauma, Percutaneous Pedicle Screw Fixation, Functional Outcome
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Research personnel changes prevented study initiation and enrollment
Enrolment: 0 participants (actual)
Lead sponsor: Daniel AltmanUniversity, hospital or other
Study start: Jul 2014
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 26 May 2014 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Percutaneous Pedicle Screw Fixation	Experimental	Procedure: Percutaneous Pedicle Screw FixationPercutaneous Pedicle Screw Fixation
Open Treatment	Active comparator	Procedure: Open TreatmentMidline posterior incision with instrumentation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (8 listed)

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.

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
Percutaneous Pedicle Screw FixationPercutaneous Pedicle Screw Fixation	Procedure or surgery	Percutaneous Pedicle Screw Fixation
Open TreatmentMidline posterior incision with instrumentation.	Procedure or surgery	Open Treatment

Primary outcome

Change in Health Related Quality of Life Measure Scores
Time frame: 24 months
Oswestry Disability Index, Roland Morris Disability Score, Visual Analog Spine Score, Euroqol 5D-5L

10 secondary outcomes

Radiographic Evaluations
Time frame: 24 months
Cost Effectiveness
Time frame: Duration of Hospital Stay (expected duration average 1 week)
Complication rate/Adverse event
Time frame: 24 months
Additional medical procedures
Time frame: 24 months
Length of Hospital Stay
Time frame: Duration of hospital stay (expected duration average 1 week)
Estimated Blood Loss
Time frame: Duration of hospital visit (expected duration- average 1 week)
Return to work
Time frame: 24 months
Radiographic Evaluation
Time frame: 24 months
Operating Time
Time frame: Duration of hospital visit (expected duration 1 week)
Fluoroscopy time
Time frame: Duration of hospital stay (expected duration average 1 week)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.

Related trials for Thoracolumbar Spine Trauma

Not yet recruitingObservational study
Controlled Reduction of AO Spine B3 Fractures in Ankylosing Spinal Disorders Using an Inflatable Positioning Device: Technical Note and Retrospective Single-centre Case Series
Spine Fracture, Osteoporosis
Recruiting
Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture
SPINAL Fracture, Burst Fracture
Recruiting
Three Dimensional Gait Analysis and Electromyography After Stabilisation of Thoracolumbar Spine Fractures Focusing on Possible Temporal Diferences in Physiological Gait Recovery Through Comparison of Open and Minimally Invasive Approaches.
Spine Fracture
Recruiting
ORthosis vs No Orthosis After Surgically Treated Traumatic Thoracolumbar Fractures
Spine Fracture, Orthosis

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Pedicle Screw Fixation and Open Treatment in people with Thoracolumbar Spine Trauma, run by Daniel Altman 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 2 Feb 2017. 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 was withdrawn before enrolling participants, so there are no results.

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?

Change in Health Related Quality of Life Measure Scores (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02146729.

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 2 Feb 2017.