SPINAL FractureNCT03312998
Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorsolumbar Spine Fracture
A study testing Xrays in people with SPINAL Fracture, run by Assiut University.
Trial summary
Recording incidence of metal failure in transpedicular screws fixation of dorsal umbra spine fracture during first year follow up Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- SPINAL Fracture
- What is being tested?
- Xrays
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Dec 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- post traumatic dorsolumbar spine fracture fixed with short or long segment transpedicular screws
- With or without decompression
Who cannot join
- pediatric patients
- Pathological fractures
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorso Lumbar Spine Fracture
Recording incidence of metal failure in transpedicular screws fixation of dorsal umbra spine fracture during first year follow up
- Conditions
- SPINAL Fracture
- Being tested
- Xrays
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XraysRadiation
Plain x-rays anteroposterior and lateral views to determine system failure
| Study group | Role | What they receive |
|---|---|---|
| Xrays | Experimental | Not described Receives: Radiation: Xrays |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiological assessment of transpedicular screws after dorsolumbar fixation
Broken rods screws loosening of screws and nuts
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SPINAL FractureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moh Salah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312998
- Sponsor's protocol ID
- 17100187
- Status last verified
- Oct 2017
- First submitted
- 6 Oct 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Riaz-ur-Rehman, Azmatullah, Azam F, Mushtaq, Shah M. Treatment of traumatic unstable thoracolumbar junction fractures with transpedicular screw fixation. J Pak Med Assoc. 2011 Oct;61(10):1005-8.
PubMed 22356037Wang L, Yan J, Li Y, Xu K, Li S, Tang P, Li H. The influence of hydroxypropyl-beta-cyclodextrin on the solubility, dissolution, cytotoxicity, and binding of riluzole with human serum albumin. J Pharm Biomed Anal. 2016 Jan 5;117:453-63. doi: 10.1016/j.jpba.2015.09.033. Epub 2015 Oct 9.
PubMed 26454338Moon MS, Kim SS, Lee BJ, Moon JL, Lin JF, Moon YW. Radiographic assessment of congenital C2-3 synostosis. J Orthop Surg (Hong Kong). 2010 Aug;18(2):143-7. doi: 10.1177/230949901001800203.
PubMed 20808002Moon MS, Choi WT, Sun DH, Chae JW, Ryu JS, Chang H, Lin JF. Instrumented ligamentotaxis and stabilization of compression and burst fractures of dorsolumbar and mid-lumbar spines. Indian J Orthop. 2007 Oct;41(4):346-53. doi: 10.4103/0019-5413.36999.
PubMed 21139790
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorso Lumbar Spine Fracture
- ClinicalTrials.gov ID
- NCT03312998
- Acronym / sponsor ID
- 17100187
- Conditions
- SPINAL Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 18 Oct 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.
Recording incidence of metal failure in transpedicular screws fixation of dorsal umbra spine fracture during first year follow up
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xrays | Experimental | Radiation: Xrays |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- post traumatic dorsolumbar spine fracture fixed with short or long segment transpedicular screws
- With or without decompression
Key exclusion criteria (2 listed)
- pediatric patients
- Pathological fractures
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 |
|---|---|---|
| XraysPlain x-rays anteroposterior and lateral views to determine system failure | Radiation | Xrays |
Primary outcome
radiological assessment of transpedicular screws after dorsolumbar fixation
Time frame: 1 year
Broken rods screws loosening of screws and nuts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Background: PubMed 22356037Riaz-ur-Rehman, Azmatullah, Azam F, Mushtaq, Shah M. Treatment of traumatic unstable thoracolumbar junction fractures with transpedicular screw fixation. J Pak Med Assoc. 2011 Oct;61(10):1005-8.
- Background: PubMed 26454338Wang L, Yan J, Li Y, Xu K, Li S, Tang P, Li H. The influence of hydroxypropyl-beta-cyclodextrin on the solubility, dissolution, cytotoxicity, and binding of riluzole with human serum albumin. J Pharm Biomed Anal. 2016 Jan 5;117:453-63. doi: 10.1016/j.jpba.2015.09.033. Epub 2015 Oct 9.
- Background: PubMed 20808002Moon MS, Kim SS, Lee BJ, Moon JL, Lin JF, Moon YW. Radiographic assessment of congenital C2-3 synostosis. J Orthop Surg (Hong Kong). 2010 Aug;18(2):143-7. doi: 10.1177/230949901001800203.
- Background: PubMed 21139790Moon MS, Choi WT, Sun DH, Chae JW, Ryu JS, Chang H, Lin JF. Instrumented ligamentotaxis and stabilization of compression and burst fractures of dorsolumbar and mid-lumbar spines. Indian J Orthop. 2007 Oct;41(4):346-53. doi: 10.4103/0019-5413.36999.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Xrays in people with SPINAL Fracture, run by Assiut 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed S Kotp (00201001887753, Dr_moh_salah1985@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiological assessment of transpedicular screws after dorsolumbar fixation (time frame: 1 year). 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 NCT03312998, which also lists 4 linked publications.
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 19 Oct 2017.