Fixation of Displaced Midshaft Clavicular Fractures in Adults by Intramedullary Elastic Rod

Overview

Clavicular fracture, constitutes 2.6% e 5% of all adult fractures, most are located in the midshaft clavicle with different degrees of displacement. Conservative methods are commonly used for midshaft clavicular fractures treatment, but with various unsatisfactory complications such as nonunion, malunion and shoulders asymmetry. The rate of malunion after conservative treatment for the midshaft clavicular fractures reached 15%, and 30% patients were unsatisfied. Recently, early midshaft clavicular fractures could greatly reduce the incidence rate of nonunion and malunion. Open reduction and plate-screw fixation was considered as the gold standard with the advantages of firm fixation and earlier postoperative mobilization, but also with disadvantages of larger incision and more organizations being exposed, presenting with many postoperative complications. Intramedullary fixation treatment for mid-clavicular fractures has been favored due to its strengths including small incision, less periosteal striping, dispersion of stress and simple to operate However, early intra-medullary implants, such as Hagie pins and Kirschner wires, have been gradually replaced due to insufficient stability. In addition, various nails such as elastic stable intramedullar

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 20, 2018

Detailed Description

Fixation of displaced midshaft clavicular fractures with minimally invasive technic as it helps for early mobilization to the shoulder and more safe, more cosmetically in comparison to other options.

Interventions

  • Procedure: Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .
    • A group of 15 patients admitted to Assiut university with midshaft clavicular fractures treated by operative fixation of the fracture by single elastic rod through medial approach under image intensifier

Arms, Groups and Cohorts

  • Experimental: Elastic rod fixation
    • Percutaneous intramedullary fixation of displaced midshaft clavicular fractures

Clinical Trial Outcome Measures

Primary Measures

  • Union rate
    • Time Frame: Six months
    • We will compares rat of union between fixation of clavicular fracture by intramedullary elastic rod and other methods of fixation

Participating in This Clinical Trial

Adults pt aged (16-55 ) how is active presented with mid shaft clavicular fracture, displacement with no comorbidity and excluding pt with polytrauma aged above 55y or below 16y ,pt with fracture lateral 3rd and pt with comorbidity

Gender Eligibility: All

Male or female who is adult, active

Minimum Age: 16 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Abdelrhman Ebrahem Kenan, Principal investigator – Assiut University
  • Overall Official(s)
    • Faisal Fahmy Adam, Professor, Study Chair, Head of orthopedic and traumatology department

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