NCT03312998

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

October 6, 2017

Last Update Submit

October 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • radiological assessment of transpedicular screws after dorsolumbar fixation

    Broken rods screws loosening of screws and nuts

    1 year

Study Arms (1)

Xrays

EXPERIMENTAL
Radiation: Xrays

Interventions

XraysRADIATION

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

Xrays

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pediatric patients
  • Pathological fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 22356037BACKGROUND
  • 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.

    PMID: 26454338BACKGROUND
  • 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.

    PMID: 20808002BACKGROUND
  • 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.

    PMID: 21139790BACKGROUND

MeSH Terms

Conditions

Spinal Fractures

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 18, 2017

Study Start

December 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

October 19, 2017

Record last verified: 2017-10