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

Primary Purpose

SPINAL Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Xrays
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for SPINAL Fracture

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • pediatric patients
  • Pathological fractures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Xrays

    Arm Description

    Outcomes

    Primary Outcome Measures

    radiological assessment of transpedicular screws after dorsolumbar fixation
    Broken rods screws loosening of screws and nuts

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2017
    Last Updated
    October 17, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03312998
    Brief Title
    Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorsolumbar Spine Fracture
    Official Title
    Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorso Lumbar Spine Fracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2017 (Anticipated)
    Primary Completion Date
    December 1, 2019 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SPINAL Fracture

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Xrays
    Arm Type
    Experimental
    Intervention Type
    Radiation
    Intervention Name(s)
    Xrays
    Intervention Description
    Plain x-rays anteroposterior and lateral views to determine system failure
    Primary Outcome Measure Information:
    Title
    radiological assessment of transpedicular screws after dorsolumbar fixation
    Description
    Broken rods screws loosening of screws and nuts
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients post traumatic dorsolumbar spine fracture fixed with short or long segment transpedicular screws With or without decompression Exclusion Criteria: pediatric patients Pathological fractures
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed S Kotp
    Phone
    00201001887753
    Email
    Dr_moh_salah1985@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22356037
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26454338
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20808002
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21139790
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

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