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Trial record 1 of 1 for:    NCT04092374
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Assiut University Heart Hospital (aun)

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ClinicalTrials.gov Identifier: NCT04092374
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Kareem Ahmed Hosny, Assiut University

Brief Summary:
It is interesting to examine this technique for sternal fracture fixation for more close-up assessment of post-operative pain using pain score, hospital stay and short-term complications. Investigators think that this approach will give the patient better post-operative results with less complications and excellent immediate relief with good quality of life, less post-operative pain and rapid return to normal life.

Condition or disease Intervention/treatment Phase
Sternal Fracture Procedure: Locking compression plates Not Applicable

Detailed Description:

Traumatic sternal fracture occurs due to direct anterior trauma to the chest or due to indirect trauma through flexion-compression of the spine. Trauma may lead to Type I manubri-sternal dislocation ( Corpi sterni displaced dorsally) or type II dislocation( corpi sterni is displaced ventrally) or it may lead to horizontal or longitudinal fractures.

Current management of such fractures includes conservative management as first line therapy. Correction Tape, plaster bandage, avoiding aggressive movement and analgesics are examples of conservative management. If the patient shows persistent pain, persistent displacement, instability, pressure over internal organs or vessels surgical reduction and fixation is indicated. However, there are no standard surgical approach for such fractures due to few numbers of studies and cases so it needs more investigations to establish evidence-based recommendations and standardization for these cases. Current surgical approaches include fixation using k-wires, cerclage wiring and more recently plates and screws.

Wiring fixation technique is the conventional technique used at our trauma centre. Investigators identified many complications from using wires as method of fixation. They include Sternal Wound Infection (SWI), sternal dehiscence, persistent pain and mal-alignment. They can be explained through the mechanism of fixation of plates. Loosening or tightening of wires twisting can lead to failure of function. In-complete burying of wires stump can lead to discomfort up-to painful sensation by the patient and may lead to sternal skin infection.

At contrast, Locking Compression Plates (LCP) system is a more recent technique used for sternal fractures fixation and is not thoroughly examined although it shows promising results at such cases. It does not depend on friction between bone and plates for fracture fixation which may fail at patients suffering from osteopenic bones or elder individuals. It depends on angle between screws and plates which is fixed showing long-term fixation over many years.

All of the previous made us interesting to examine this technique for sternal fracture fixation for more close-up assessment of post-operative pain using pain score, hospital stay and short-term complications. Investigators think that this approach will give the patient better post-operative results with less complications and excellent immediate relief with good quality of life, less post-operative pain and rapid return to normal life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sternal Fracture Fixation by Locking Compression Plates (LCP) System
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Case arm Procedure: Locking compression plates
Fixation of sternal fracture using locking compression mechanism




Primary Outcome Measures :
  1. Post operative pain: score [ Time Frame: Early post operative period up to one week ]
    Pain score for post operative period in patients using locking compression plates.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Traumatic sternal fractures
  2. All patients of all ages and genders are included
  3. All types of sternal fractures and manubri-sternal junction dislocation.

Exclusion Criteria:

  1. All patient with Associated Injury Scale score of more than
  2. Patients having their sternal fractures fixed using fixation approach other than LCP plates and screws.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092374


Contacts
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Contact: Kareem Ahmed Hosny 01000401994 kareemdna94@gmail.com

Locations
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Egypt
Assiut university heart hospital Recruiting
Assiut, Egypt, 2112
Contact: Kareem Ahmed Hosny, Bachelor of medicine    01000401994    kareemdna94@gmail.com   
Sponsors and Collaborators
Assiut University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kareem Ahmed Hosny, Resident Surgeon, Assiut University
ClinicalTrials.gov Identifier: NCT04092374    
Other Study ID Numbers: AssiutUniv
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: No
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries