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

Primary Purpose

Clavicular Fracture

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .

About this trial

This is an interventional treatment trial for Clavicular Fracture focused on measuring Fixation of midshaft clavicular fracture by intramedullary

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elastic rod fixation

Arm Description

Percutaneous intramedullary fixation of displaced midshaft clavicular fractures

Outcomes

Primary Outcome Measures

Union rate

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03462901

First Posted

December 8, 2017

Last Updated

March 9, 2018

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03462901

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 30, 2016 (Actual)

Primary Completion Date

October 20, 2018 (Anticipated)

Study Completion Date

May 21, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clavicular Fracture

Keywords

Fixation of midshaft clavicular fracture by intramedullary

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Fracture clavicle in adults

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Elastic rod fixation

Arm Type

Experimental

Arm Description

Percutaneous intramedullary fixation of displaced midshaft clavicular fractures

Intervention Type

Procedure

Intervention Name(s)

Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .

Other Intervention Name(s)

Intramedulary fixation of clavicular fractures

Intervention Description

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

Primary Outcome Measure Information:

Title

Union rate

Description

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

Time Frame

Six months

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Male or female who is adult, active

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Faisal Fahmy Adam, Professor

Organizational Affiliation

Head of orthopedic and traumatology department

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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