Assiut University Heart Hospital (aun)
Primary Purpose
Sternal Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Locking compression plates
Sponsored by
About this trial
This is an interventional treatment trial for Sternal Fracture
Eligibility Criteria
Inclusion Criteria:
- Traumatic sternal fractures
- All patients of all ages and genders are included
- All types of sternal fractures and manubri-sternal junction dislocation.
Exclusion Criteria:
- All patient with Associated Injury Scale score of more than
- Patients having their sternal fractures fixed using fixation approach other than LCP plates and screws.
Sites / Locations
- Assiut university heart hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Case arm
Arm Description
Outcomes
Primary Outcome Measures
Post operative pain: score
Pain score for post operative period in patients using locking compression plates.
Secondary Outcome Measures
Full Information
NCT ID
NCT04092374
First Posted
September 14, 2019
Last Updated
September 17, 2019
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT04092374
Brief Title
Assiut University Heart Hospital
Acronym
aun
Official Title
Sternal Fracture Fixation by Locking Compression Plates (LCP) System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sternal Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Case arm
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Locking compression plates
Intervention Description
Fixation of sternal fracture using locking compression mechanism
Primary Outcome Measure Information:
Title
Post operative pain: score
Description
Pain score for post operative period in patients using locking compression plates.
Time Frame
Early post operative period up to one week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Traumatic sternal fractures
All patients of all ages and genders are included
All types of sternal fractures and manubri-sternal junction dislocation.
Exclusion Criteria:
All patient with Associated Injury Scale score of more than
Patients having their sternal fractures fixed using fixation approach other than LCP plates and screws.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kareem Ahmed Hosny
Phone
01000401994
Email
kareemdna94@gmail.com
Facility Information:
Facility Name
Assiut university heart hospital
City
Assiut
ZIP/Postal Code
2112
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kareem Ahmed Hosny, Bachelor of medicine
Phone
01000401994
Email
kareemdna94@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32825827
Citation
Ahmed K, Nady MA. Sternal reconstruction using locking compression plates (LCP): our experience in Egypt, a case series. J Cardiothorac Surg. 2020 Aug 21;15(1):224. doi: 10.1186/s13019-020-01266-0.
Results Reference
derived
Learn more about this trial
Assiut University Heart Hospital
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