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NCT03312998 Clinical Trial

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

SPINAL Fracture Clinical Trial

Official title:
Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorso Lumbar Spine Fracture

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03312998
Other study ID # 17100187
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 6, 2017
Last updated October 17, 2017
Start date December 1, 2017
Est. completion date December 1, 2020

Study information
Verified date October 2017
Source Assiut University
Contact Mohamed S Kotp
Phone 00201001887753
Email Dr_moh_salah1985@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Xrays
Plain x-rays anteroposterior and lateral views to determine system failure

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (4)

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. — View 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. — View 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. — View Citation

Wang L, Yan J, Li Y, Xu K, Li S, Tang P, Li H. The influence of hydroxypropyl-ß-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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary radiological assessment of transpedicular screws after dorsolumbar fixation Broken rods screws loosening of screws and nuts 1 year
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