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

NCT ID: NCT03462901

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-30
• Study Completion Date: 2019-05-21

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

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.

Conditions

Clavicular Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Elastic rod fixation

Percutaneous intramedullary fixation of displaced midshaft clavicular fractures

Group Type: EXPERIMENTAL

Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Intramedulary fixation of clavicular fractures

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrhman Ebrahem Kenan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faisal Fahmy Adam, Professor

Role: STUDY_CHAIR

Head of orthopedic and traumatology department

Other Identifiers

17100365

Identifier Type: -

Identifier Source: org_study_id