Single Level Stable Thoracolumbar Fracture Type AO A3FA3NCT01751633
Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures
An observational study of Single Level Stable Thoracolumbar Fracture Type AO A3 and Multiple Level Stable Thoracolumbar Fracture Type AO A3, run by AO Clinical Investigation and Publishing Documentation at 8 sites in 6 countries.
Trial summary
Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3 ("burst fractures"). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Single Level Stable Thoracolumbar Fracture Type AO A3, Multiple Level Stable Thoracolumbar Fracture Type AO A3
- What is being tested?
- Surgical and Conservative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Jan 2013to Dec 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 140 subjects patients with thoracolumbar fractures will be assigned to ei-ther conservative or surgical treatment depending on the surgeon's decision. Patients will be treated at each institution per standard of care. Surgeons will use their expertise and preferences to determine the method of surgical or conservative intervention.
Who may be able to join
- Age 18-65 years
- Diagnosis of single or multiple stable thoracolumbar fracture(s)
- Level T10- L3
- Type AO A3 or A4
- Radiologically confirmed by Rx or CT
- Fracture induced kyphotic deformity lower or equal to 20-35 degrees
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- Definitive treatment (surgical or conservative) within 10 days after injury
- American Spinal Injury Association (ASIA) Impairment Scale = E (normal )
- Ability to understand patient information / informed consent form
- Willingness and ability to participate in the clinical investigation including imaging and follow-up procedures (FUs)
- Signed informed consent
Who cannot join
- Open fracture
- Polytrauma
- Pathologic fracture
- Disruption of the posterior ligamentous complex between T10 and L3
- Clinically evident osteoporosis as assessed by the investigator
- Spinal luxation
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- Associated severe lesions as assessed by the investigator
- Spinal lesion due to gun or projectile
- Pre-existing spinal column deformity
- Prior spinal surgeries
- BMI > 40 kg/m2
- Any severe medically not managed systemic disease
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reli-able assessment
- Pregnancy or women planning to conceive within the study period
- Prisoner
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Brazil3 sites
Hospital Universitaria Cajuru
Curitiba
Hospital Cristo Redentor
Porto Alegre
Hospital Santa Marcelina
São Paulo
Germany1 site
Klinikum rechts der Isar der Technischen Universität München
Munich
About this study
Official title: Comparison of Surgical Versus Conservative Treatment of AO Type A3 Thoracolumbar Fractures Without Neurological Deficits Prospective, International, Multicenter Cohort Study
Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3 ("burst fractures"). Although patients with burst fractures report a reduced quality of life and chronic pain, there is no clear evidence whether surgical or conservative treatment offer better functional and back-pain related outcomes. The indications for the selection of an ideal treatment for these fractures without neurological deficits remain controversial. The purpose of this study is to evaluate whether patients with thoracolumbar fractures without neurological deficit being surgically treated show faster recovery and better improvement of function than patients being conservatively treated.
- Conditions
- Single Level Stable Thoracolumbar Fracture Type AO A3, Multiple Level Stable Thoracolumbar Fracture Type AO A3
- Being tested
- Surgical, Conservative treatment
- Keywords
- Burst fractures, Thoracic or Lumbar Vertebrae/injuries [MeSH], Thoracic or Lumbar Vertebrae/surgery [MeSH], Spinal Fusion/methods [MeSH], Thoracolumbar fracture management, Quality of life, Functional outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgicalProcedure or surgery
Also called • Posterior open approach, • Posterior minimally-invasive surgery (MIS) approach
Conservative treatmentProcedure or surgery
Also called Conservative treatment according to hospital's standard of care :, - Bed rest followed by immobilization with:, - Custom-moulded or prefabricated total body contact thoracolumbosacral orthosis (TLSO), - Thermoplastic removable brace, Jewett hyperextension braces, Anterior hyperextension brace (ASH), Taylor-Knight brace
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Surgical treatment according to one of the following:
* Posterior open approach
* Posterior minimally-invasive surgery (MIS) approach The choice of the approach will be left upon the surgeon's discretion Receives: Procedure: Surgical | |
| Conservative treatment | Conservative treatment according to hospital's standard of care Receives: Procedure: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland-Morris Disability Questionnaire (RMDQ)
Improvement in functional outcome from baseline to 6 week follow up (FU) measured with the Roland-Morris Disability Questionnaire (RMDQ)
Measured: 6 week follow up
Secondary outcomes (7)
Back pain related disability (Roland-Morris Disability Questionnaire RMDQ)
Measured: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Pain (Numeric Rating Scale (NRS))
Measured: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU
Radiologic progress taking into account RX, CT and optionally MRI
Measured: baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months
Quality of return to work (Denis Work Scale)
Measured: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Time to return to work
Measured: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Conservative treatment failure rate (eg, change to surgical treatment)
Measured: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Rates of local adverse events (AE)
Measured: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2015
- Study completionDec 2015
Why it stopped: Administrative reason. Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Level Stable Thoracolumbar Fracture Type AO A3Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Barbagallo, MD, Principal investigator, Azienda Ospedaliero - Universitaria Policlinico, Catania, ItalyEmiliano Vialle, MD, Principal investigator, Catholic University of Parana - Curitiba, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751633
- Sponsor's protocol ID
- Spine FA3
- Acronym
- FA3
- Status last verified
- Aug 2020
- First submitted
- 14 Dec 2012
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Versus Conservative Treatment of AO Type A3 Thoracolumbar Fractures Without Neurological Deficits Prospective, International, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT01751633
- Acronym / sponsor ID
- FA3 / Spine FA3
- Conditions
- Single Level Stable Thoracolumbar Fracture Type AO A3, Multiple Level Stable Thoracolumbar Fracture Type AO A3
- Keywords
- Burst fractures, Thoracic or Lumbar Vertebrae/injuries [MeSH], Thoracic or Lumbar Vertebrae/surgery [MeSH], Spinal Fusion/methods [MeSH], Thoracolumbar fracture management, Quality of life, Functional outcome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Administrative reason. Lack of funding.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Dec 2012 (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.
Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3 ("burst fractures"). Although patients with burst fractures report a reduced quality of life and chronic pain, there is no clear evidence whether surgical or conservative treatment offer better functional and back-pain related outcomes. The indications for the selection of an ideal treatment for these fractures without neurological deficits remain controversial. The purpose of this study is to evaluate whether patients with thoracolumbar fractures without neurological deficit being surgically treated show faster recovery and better improvement of function than patients being conservatively treated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | – | Procedure: SurgicalSurgical treatment according to one of the following: * Posterior open approach * Posterior minimally-invasive surgery (MIS) approach The choice of the approach will be left upon the surgeon's discretion |
| Conservative treatment | – | Procedure: Conservative treatmentConservative treatment according to hospital's standard of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 140 subjects patients with thoracolumbar fractures will be assigned to ei-ther conservative or surgical treatment depending on the surgeon's decision. Patients will be treated at each institution per standard of care. Surgeons will use their expertise and preferences to determine the method of surgical or conservative intervention.
Key inclusion criteria (11 listed)
- Age 18-65 years
- Diagnosis of single or multiple stable thoracolumbar fracture(s)
- Fracture induced kyphotic deformity lower or equal to 20-35 degrees
- Definitive treatment (surgical or conservative) within 10 days after injury
- American Spinal Injury Association (ASIA) Impairment Scale = E (normal )
Key exclusion criteria (16 listed)
- Open fracture
- Polytrauma
- Pathologic fracture
- Disruption of the posterior ligamentous complex between T10 and L3
- Clinically evident osteoporosis as assessed by the investigator
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 |
|---|---|---|
| SurgicalAlso: • Posterior open approach, • Posterior minimally-invasive surgery (MIS) approach | Procedure or surgery | Surgical treatment |
| Conservative treatmentAlso: Conservative treatment according to hospital's standard of care :, - Bed rest followed by immobilization with:, - Custom-moulded or prefabricated total body contact thoracolumbosacral orthosis (TLSO), - Thermoplastic removable brace, Jewett hyperextension braces, Anterior hyperextension brace (ASH), Taylor-Knight brace | Procedure or surgery | Conservative treatment |
Primary outcome
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: 6 week follow up
Improvement in functional outcome from baseline to 6 week follow up (FU) measured with the Roland-Morris Disability Questionnaire (RMDQ)
7 secondary outcomes
Back pain related disability (Roland-Morris Disability Questionnaire RMDQ)
Time frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Pain (Numeric Rating Scale (NRS))
Time frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU
Radiologic progress taking into account RX, CT and optionally MRI
Time frame: baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months
Quality of return to work (Denis Work Scale)
Time frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Time to return to work
Time frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Conservative treatment failure rate (eg, change to surgical treatment)
Time frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Rates of local adverse events (AE)
Time frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Results and safety
The study was stopped early (reason given: Administrative reason. Lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
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.
Giuseppe Barbagallo, MD principal investigator
Azienda Ospedaliero - Universitaria Policlinico, Catania, Italy
Emiliano Vialle, MD principal investigator
Catholic University of Parana - Curitiba, Brazil
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single Level Stable Thoracolumbar Fracture Type AO A3 and Multiple Level Stable Thoracolumbar Fracture Type AO A3, run by AO Clinical Investigation and Publishing Documentation at 8 sites in 6 countries.
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 11 inclusion and 16 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: stopped early, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil, Chile, Czechia, Germany, Italy and 1 more country. 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 stopped early (reason given: Administrative reason. Lack of funding.). Results are not available in the source record.
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?
Roland-Morris Disability Questionnaire (RMDQ) (time frame: 6 week follow up). 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 13 Aug 2020.