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

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 Overview

• Status: Unknown
• Conditions: Clavicular Fracture
• Intervention / Treatment: Procedure: Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Elastic rod fixation; Percutaneous intramedullary fixation of displaced midshaft clavicular fractures	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; Other Names: Intramedulary fixation of clavicular fractures

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Faisal Fahmy Adam, Professor, Head of orthopedic and traumatology department

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2016
• Primary Completion (ANTICIPATED): October 20, 2018
• Study Completion (ANTICIPATED): May 21, 2019

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (ACTUAL): March 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 9, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Fixation of midshaft clavicular fracture by intramedullary
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 17100365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Select patients and do the surgery and follow up prognosis
• IPD Sharing Time Frame: After six months
• IPD Sharing Access Criteria: Early preserve of shoulder activity
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes