SPINAL FractureNCT03272243
Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures
A study testing short segment posterior spine fixation and long segment posterior spine fixation in people with SPINAL Fracture, run by Ain Shams University.
Trial summary
A prospective study included 91 patients, who had single level thoracolumbar fracture with Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment fixation with screws into the index level, and 47 patients underwent long segment fixation with skipped index level. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SPINAL Fracture
- What is being tested?
- short segment posterior spine fixation and long segment posterior spine fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2012to 30 Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- wedge fracture or burst fracture with Thoraco-Lumbar Injury Classification and Severity (TLICS) score ≥ 4
- Single level fracture
- Less than 50% of spinal canal compromised
- Mild kyphosis or scoliosis
- Cobb's angle ≤ 25˚
- with or without neurological deficit
Who cannot join
- patients with multiple level fractures
- patients with more than 50% spinal canal compromise
- patients who needed anterior approach to decompress the canal
- patients who have fracture dislocation and / or marked kyphosis and scoliosis with Cobb's angle >25⁰
- patients who needed 360⁰ fixation with long segment fixation to maintain the angle of correction.
About this study
Official title: Short Segment Posterior Fixation With Index Level Screws Versus Long Segment Posterior Fixation for Thoracolumbar Spine Fracture: Angle of Correction and Pain
A prospective study included 91 patients, who had single level thoracolumbar fracture with Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment fixation with screws into the index level, and 47 patients underwent long segment fixation with skipped index level. The angle of correction, pain, and neurological state were regularly assessed
- Conditions
- SPINAL Fracture
- Being tested
- short segment posterior spine fixation, long segment posterior spine fixation
- Keywords
- thoracolumbar fracture, short segment fixation, long segment fixation, index level
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short segment posterior spine fixationProcedure or surgery
long segment posterior spine fixationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Short Segment posterior spine fixation | Active comparator | Short segment transpedicular screw fixation with inclusion of the index level Receives: Procedure: short segment posterior spine fixation |
| Long Segment posterior spine fixation | Active comparator | Long segment transpedicular screw fixation with escape of the index level Receives: Procedure: long segment posterior spine fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
Visual analogue scale assessment
Measured: 3rd, 6th, 9th, 12th months
Change in disability
assessment of Oswestry Disability Scale
Measured: 3rd, 6th, 9th, 12th months
Change in angle of correction
Measurement of Cobb's angle
Measured: 3rd, 6th, 9th, 12th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Feb 2012
- Primary completion28 Feb 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SPINAL FractureStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Nada, Ain Shams University
- Investigators
- Walid A Abdel Ghany, M.D., Ph.D, Study director, Associate Professor of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272243
- Sponsor's protocol ID
- G10800
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Segment Posterior Fixation With Index Level Screws Versus Long Segment Posterior Fixation for Thoracolumbar Spine Fracture: Angle of Correction and Pain
- ClinicalTrials.gov ID
- NCT03272243
- Acronym / sponsor ID
- G10800
- Conditions
- SPINAL Fracture
- Keywords
- thoracolumbar fracture, short segment fixation, long segment fixation, index level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 5 Sep 2017 (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.
A prospective study included 91 patients, who had single level thoracolumbar fracture with Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment fixation with screws into the index level, and 47 patients underwent long segment fixation with skipped index level. The angle of correction, pain, and neurological state were regularly assessed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Segment posterior spine fixation | Active comparator | Procedure: short segment posterior spine fixationShort segment transpedicular screw fixation with inclusion of the index level |
| Long Segment posterior spine fixation | Active comparator | Procedure: long segment posterior spine fixationLong segment transpedicular screw fixation with escape of the index level |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- wedge fracture or burst fracture with Thoraco-Lumbar Injury Classification and Severity (TLICS) score ≥ 4
- Single level fracture
- Less than 50% of spinal canal compromised
- Mild kyphosis or scoliosis
- Cobb's angle ≤ 25˚
Key exclusion criteria (5 listed)
- patients with multiple level fractures
- patients with more than 50% spinal canal compromise
- patients who needed anterior approach to decompress the canal
- patients who have fracture dislocation and / or marked kyphosis and scoliosis with Cobb's angle >25⁰
- patients who needed 360⁰ fixation with long segment fixation to maintain the angle of correction.
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 |
|---|---|---|
| short segment posterior spine fixation | Procedure or surgery | Short Segment posterior spine fixation |
| long segment posterior spine fixation | Procedure or surgery | Long Segment posterior spine fixation |
Primary outcome
Change in pain
Time frame: 3rd, 6th, 9th, 12th months
Visual analogue scale assessment
Change in disability
Time frame: 3rd, 6th, 9th, 12th months
assessment of Oswestry Disability Scale
Change in angle of correction
Time frame: 3rd, 6th, 9th, 12th months
Measurement of Cobb's angle
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 6 Sep 2017.
- Individual participant dataSharing planned: Yes
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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.
Walid A Abdel Ghany, M.D., Ph.D study director
Associate Professor of Neurosurgery
Questions about this trial
What is this clinical trial studying?
A study testing short segment posterior spine fixation and long segment posterior spine fixation in people with SPINAL Fracture, run by Ain Shams University.
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 6 inclusion and 5 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 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in pain (time frame: 3rd, 6th, 9th, 12th months). The study lists 3 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 6 Sep 2017.