Assiut University Heart Hospital (aun)

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Kareem Ahmed Hosny, Resident Surgeon, Assiut University
• ClinicalTrials.gov Identifier: NCT04092374
• Other Study ID Numbers: AssiutUniv
• First Posted: September 17, 2019
• Last Update Posted: September 19, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Fractures, Bone; Wounds and Injuries