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
About this trial
This is an interventional diagnostic trial for SPINAL Fracture
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
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
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
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Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorsolumbar Spine Fracture
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