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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03462901
Other study ID # 17100365
Secondary ID
Status Enrolling by invitation
Phase N/A
First received December 8, 2017
Last updated March 9, 2018
Start date October 30, 2016
Est. completion date May 21, 2019

Study information

Verified date March 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 15
Est. completion date May 21, 2019
Est. primary completion date October 20, 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Union rate We will compares rat of union between fixation of clavicular fracture by intramedullary elastic rod and other methods of fixation Six months
See also
  Status Clinical Trial Phase
Completed NCT04685291 - Ultrasound-guided Block of the Supraclavicular Nerves in Clavicular Fractures N/A