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

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

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

Study Overview

• Status: Unknown
• Conditions: SPINAL Fracture
• Intervention / Treatment: Radiation: Xrays

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed S Kotp; Phone Number: 00201001887753; Email: Dr_moh_salah1985@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xrays	Radiation: Xrays; Plain x-rays anteroposterior and lateral views to determine system failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiological assessment of transpedicular screws after dorsolumbar fixation	Broken rods screws loosening of screws and nuts	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures
• Other Study ID Numbers: 17100187

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No