Assiut University Heart Hospital

NCT ID: NCT04092374

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-06-30

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.

Conditions

Sternal Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Case arm

Group Type: EXPERIMENTAL

Locking compression plates

Intervention Type: PROCEDURE

Fixation of sternal fracture using locking compression mechanism

Interventions

Locking compression plates

Fixation of sternal fracture using locking compression mechanism

Intervention Type: PROCEDURE

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Kareem Ahmed Hosny

Resident Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university heart hospital

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Kareem Ahmed Hosny

Role: CONTACT

kareemdna94@gmail.com

01000401994

Facility Contacts

Kareem Ahmed Hosny, Bachelor of medicine

Role: primary

kareemdna94@gmail.com

01000401994

References

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.

Reference Type: DERIVED

PMID: 32825827 (View on PubMed)

Other Identifiers

AssiutUniv

Identifier Type: -

Identifier Source: org_study_id