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
• 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
• 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

Related Conditions & MeSH terms

• Fractures, Bone
• SPINAL Fracture
• Spinal Fractures

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