Assiut University Heart Hospital

Sternal Fracture Clinical Trial

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Official title:

Sternal Fracture Fixation by Locking Compression Plates (LCP) System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092374
• Other study ID #: AssiutUniv
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: Kareem Ahmed Hosny
• Phone: 01000401994
• Email: kareemdna94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Sternal Fracture

Intervention

Procedure:
• Locking compression plates
Fixation of sternal fracture using locking compression mechanism

Locations

Country	Name	City	State
Egypt	Assiut university heart hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain: score	Pain score for post operative period in patients using locking compression plates.	Early post operative period up to one week