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Assiut University Heart Hospital

Sternal Fracture Fixation by Locking Compression Plates (LCP) System

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04092374
Acronym
aun
Enrollment
10
Registered
2019-09-17
Start date
2019-01-01
Completion date
2022-06-30
Last updated
2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sternal Fracture

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.

Interventions

Fixation of sternal fracture using locking compression mechanism

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post operative pain: scoreEarly post operative period up to one weekPain score for post operative period in patients using locking compression plates.

Countries

Egypt

Contacts

Primary ContactKareem Ahmed Hosny
kareemdna94@gmail.com01000401994

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026