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Status unknownNCT03312998Updated Oct 19, 2017

Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorsolumbar Spine Fracture

An interventional study of Xrays in SPINAL Fracture, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-19.

Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Recording incidence of metal failure in transpedicular screws fixation of dorsal umbra spine fracture during first year follow up

02

Conditions studied

  • SPINAL Fracture

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03

In context

Spinal Fractures

144 studies on the registry are indexed under Spinal Fractures; 24 are open to participants now.

This study's planned enrollment of 100 is above the median of 85 across 85 interventional studies indexed under Spinal Fractures.

Browse Spinal Fractures studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Assiut University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients
  • post traumatic dorsolumbar spine fracture fixed with short or long segment transpedicular screws
  • With or without decompression

Exclusion criteria

Exclusion Criteria:

  • pediatric patients
  • Pathological fractures
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Xrays

    Radiation: Xrays

Interventions

  • RadiationXrays

    Plain x-rays anteroposterior and lateral views to determine system failure

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What researchers measure

Primary outcomes

  1. radiological assessment of transpedicular screws after dorsolumbar fixation

    Broken rods screws loosening of screws and nuts

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

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 22356037 ↗
  • Wang 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 26454338 ↗
  • Moon 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 20808002 ↗
  • Moon 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2017; primary completion for Dec 2019, 24 months later.

Of 36 interventional studies with no phase under Spinal Fractures, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 70. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2017
First posted
Oct 18, 2017
StartEst.
Dec 1, 2017
Primary completionEst.
Dec 1, 2019
CompletionEst.
Dec 1, 2020
Last update
Oct 19, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03312998
Lead sponsor
Assiut University
Responsible party
Moh Salah (principal investigator, Assiut University) — Principal investigator
First posted
Oct 18, 2017
Start date
Dec 1, 2017 (estimated)
Primary completion
Dec 1, 2019 (estimated)
Completion
Dec 1, 2020 (estimated)
Last update
Oct 19, 2017

Study contacts

Mohamed S Kotp
Contact
Dr_moh_salah1985@yahoo.com
00201001887753

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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