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

NCT03462901 | Unknown

• 1 other identifier: 17100365
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Clavicular Fracture

Keywords

Fixation of midshaft clavicular fracture by intramedullary

Outcome Measures

Primary Outcomes (1)

• Union rate

  We will compares rat of union between fixation of clavicular fracture by intramedullary elastic rod and other methods of fixation

  Six months

Study Arms (1)

Elastic rod fixation

EXPERIMENTAL

Percutaneous intramedullary fixation of displaced midshaft clavicular fractures

Procedure: Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .

Interventions

Percutaneous intramedullary fixation of displaced midshaft clavicular fractures . PROCEDURE

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

Also known as: Intramedulary fixation of clavicular fractures

Elastic rod fixation

Eligibility Criteria

• Age: 16 Years - 55 Years
• Gender Eligibility Details: Male or female who is adult, active
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Assiut University: lead

Study Officials

• Faisal Fahmy Adam, Professor

  Head of orthopedic and traumatology department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Fracture clavicle in adults

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: March 13, 2018
• Study Start: October 30, 2016
• Primary Completion: October 20, 2018
• Study Completion: May 21, 2019
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After six months
• Access Criteria: Early preserve of shoulder activity