Spinal FracturesNCT02179697
Randomized Trial With an Observational Component of Non-operative Versus Operative Treatment for AO Type A3 Fractures
A study testing Patient's Choice and Surgery + Bracing vs. Bracing Alone in people with Spinal Fractures, run by H Francis Farhadi at 1 site in United States.
Trial summary
The purpose of this study is to compare surgery plus bracing versus bracing alone. Both groups are considered standard of care treatments. The goal of this study is to determine which group is a better treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Fractures
- What is being tested?
- Patient's Choice and Surgery + Bracing vs. Bracing Alone
- 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
- Aug 2014to Jun 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Acute trauma patient with AO Type A3.1-A3.3 fractures of T10-L2
- Neurologically intact
- TLICS score of 4
- Women of childbearing potential must have a negative serum pregnancy test
Who cannot join
- Severe poly-trauma (Injury Severity Score >15 and/or intubation required for > 24 hours)
- Sepsis and/or organ failure
- Prior instrumented arthrodesis of the thoracolumbar spine
- Severe co-morbidities (e.g., heart, respiratory, or renal disease)
- Recent history (<3 years) of concomitant spinal tumor or infection
- Greater than single level fracture involvement (other than transverse process fractures)
Show all 18Show fewer
- AO Type A3 fracture with associated load sharing score ≥7
- ≥ 30 degrees regional kyphosis on standing
- History of autoimmune (seronegative) spondyloarthropathy (i.e., ankylosing spondylitis)
- History of osteoporosis
- Subjects who are pregnant or plan to become pregnant in the next 24 months. Patients will be advised on the use of contraceptives during this time. Methods include abstinence or two acceptable forms including condoms with spermicide, birth control pills, injections, or an IUD.
- Co-morbidity requiring medication that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, NSAIDs immunosuppressive agents, methotrexate)
- Severe morbid obesity (BMI > 40)
- History of metal sensitivity/foreign body sensitivity
- History of prior laminectomy at the fracture site
- Associated scoliotic (> 10°) or pre-existing thoracolumbar kyphotic deformity
- History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
- Prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiographic and Clinical Outcomes Following Non-operative Versus Operative Treatment of AO Type A3 Fractures: A Prospective, Randomized Clinical Trial With an Observational Component
The purpose of this study is to compare surgery plus bracing versus bracing alone. Both groups are considered standard of care treatments. The goal of this study is to determine which group is a better treatment.
Read the detailed description
Patient must be between 18 and 65 years old and had an acute trauma with an AO type A3 burst fracture (a spinal injury where one of the bony parts of the spine [vertebra] breaks due to immediate and severe compression).
The purpose of this study is to compare surgery plus bracing versus bracing alone. Patients will be followed for 10 years. The investigators will compare patients' x-ray outcomes and clinical outcomes (i.e. how a patient is feeling and how a patient is able to do usual daily activities) as well as patients' immediate and delayed medical and surgical side effects between the 2 study arms. The goal of this study is to determine if treating patients with surgery plus bracing is better than just bracing alone.
- Conditions
- Spinal Fractures
- Being tested
- Patient's Choice, Surgery + Bracing vs. Bracing Alone
- Keywords
- Groups:, Group 1 (2 Treatment Arms (Randomized between 2 treatments)), Treatment 1: Surgery + Bracing, Treatment 2: Bracing Alone, Group 2, The patient will decide which group is best for themselves.
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient's ChoiceOther
Patient chooses between surgery plus bracing or bracing alone. The patient will be followed according to the same schedule as Group 1.
Surgery + Bracing vs. Bracing AloneProcedure or surgery
Surgery + Bracing vs. Bracing Alone
| Study group | Role | What they receive |
|---|---|---|
| Surgery + Bracing vs. Bracing Alone | Active comparator | Randomize between 2 treatments:
Treatment 1: Surgery + Bracing Treatment 2: Bracing alone Receives: Procedure: Surgery + Bracing vs. Bracing Alone |
| Patient's choice | Other | Patient will decide which group is best for him/her. The patient will be followed at the same points as Group 1. Receives: Other: Patient's Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare radiologic outcomes using regional kyphosis and Evaluate clinical outcomes using questionnaires
Primary Outcome is to compare radiologic and clinical outcomes. These will be measured by regional kyphosis, at 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients; and Oswestry Disability Index, at 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients.
Measured: 2 years
Secondary outcomes (6)
Compare radiologic outcomes using regional kyphosis
Secondary outcome is to compare radiologic outcomes, as measured by regional kyphosis, at 5 and 10 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients
Measured: 5 and 10 years
Evaluate clinical outcomes using questionnaires
Secondary outcome is to evaluate clinical outcomes, as measured by the Oswestry Disability Index, at 5 and 10 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients.
Measured: 5 and 10 years
Compare global sagittal balance at 3 different time points
Secondary Outcome is to compare global sagittal balance at 2, 5, and 10 years.
Measured: 2,5, and 10 years
Collect data on patient in both groups for 10 years
Secondary Outcome is to record frequency and time to secondary surgical intervention among patients in the bracing group.
Measured: 10 years
Compare Return to work rates over a two year peiord
Secondary Outcome is to Compare return-to-work rates at 3 months, 1 year, and 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients.
Measured: 3 month, 1 year, and 2 years
Compare Health Care Cost between both groups over 10 years
Secondary Outcome is to compare health care cost and utilization through extended follow-up period.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FracturesStudies 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)
Sponsor and investigators
- Lead sponsor
- H Francis Farhadi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, H Francis Farhadi, Ohio State University
- Investigators
- Francis Frahadi, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179697
- Sponsor's protocol ID
- 2014H0100
- Status last verified
- Jan 2017
- First submitted
- 16 Jun 2014
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Clinical Outcomes Following Non-operative Versus Operative Treatment of AO Type A3 Fractures: A Prospective, Randomized Clinical Trial With an Observational Component
- ClinicalTrials.gov ID
- NCT02179697
- Acronym / sponsor ID
- 2014H0100
- Conditions
- Spinal Fractures
- Keywords
- Groups:, Group 1 (2 Treatment Arms (Randomized between 2 treatments)), Treatment 1: Surgery + Bracing, Treatment 2: Bracing Alone, Group 2, The patient will decide which group is best for themselves.
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H Francis FarhadiUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 2 Jul 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.
The purpose of this study is to compare surgery plus bracing versus bracing alone. Both groups are considered standard of care treatments. The goal of this study is to determine which group is a better treatment.
Detailed description
Patient must be between 18 and 65 years old and had an acute trauma with an AO type A3 burst fracture (a spinal injury where one of the bony parts of the spine [vertebra] breaks due to immediate and severe compression).
The purpose of this study is to compare surgery plus bracing versus bracing alone. Patients will be followed for 10 years. The investigators will compare patients' x-ray outcomes and clinical outcomes (i.e. how a patient is feeling and how a patient is able to do usual daily activities) as well as patients' immediate and delayed medical and surgical side effects between the 2 study arms. The goal of this study is to determine if treating patients with surgery plus bracing is better than just bracing alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery + Bracing vs. Bracing Alone | Active comparator | Procedure: Surgery + Bracing vs. Bracing AloneRandomize between 2 treatments: Treatment 1: Surgery + Bracing Treatment 2: Bracing alone |
| Patient's choice | Other | Other: Patient's ChoicePatient will decide which group is best for him/her. The patient will be followed at the same points as Group 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years
- Acute trauma patient with AO Type A3.1-A3.3 fractures of T10-L2
- Neurologically intact
- TLICS score of 4
- Women of childbearing potential must have a negative serum pregnancy test
Key exclusion criteria (18 listed)
- Severe poly-trauma (Injury Severity Score >15 and/or intubation required for > 24 hours)
- Sepsis and/or organ failure
- Prior instrumented arthrodesis of the thoracolumbar spine
- Severe co-morbidities (e.g., heart, respiratory, or renal disease)
- Recent history (<3 years) of concomitant spinal tumor or infection
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 |
|---|---|---|
| Patient's ChoicePatient chooses between surgery plus bracing or bracing alone. The patient will be followed according to the same schedule as Group 1. | Other | Patient's choice |
| Surgery + Bracing vs. Bracing AloneSurgery + Bracing vs. Bracing Alone | Procedure or surgery | Surgery + Bracing vs. Bracing Alone |
Primary outcome
Compare radiologic outcomes using regional kyphosis and Evaluate clinical outcomes using questionnaires
Time frame: 2 years
Primary Outcome is to compare radiologic and clinical outcomes. These will be measured by regional kyphosis, at 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients; and Oswestry Disability Index, at 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients.
6 secondary outcomes
Compare radiologic outcomes using regional kyphosis
Time frame: 5 and 10 years
Evaluate clinical outcomes using questionnaires
Time frame: 5 and 10 years
Compare global sagittal balance at 3 different time points
Time frame: 2,5, and 10 years
Collect data on patient in both groups for 10 years
Time frame: 10 years
Compare Return to work rates over a two year peiord
Time frame: 3 month, 1 year, and 2 years
Compare Health Care Cost between both groups over 10 years
Time frame: 10 years
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 18 Jan 2017.
Related trials for Spinal Fractures
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Vertebral Compression Fractures, Pathological Fracture
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.
Francis Frahadi, MD, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient's Choice and Surgery + Bracing vs. Bracing Alone in people with Spinal Fractures, run by H Francis Farhadi 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 18 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 18 Jan 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?
Compare radiologic outcomes using regional kyphosis and Evaluate clinical outcomes using questionnaires (time frame: 2 years). 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 18 Jan 2017.