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AzTrials

Sternal FractureaunNCT04092374

Assiut University Heart Hospital

A study testing Locking compression plates in people with Sternal Fracture, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Sternal Fracture
What is being tested?
Locking compression plates
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteEgypt
Study dates
1 Jan 2019to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Traumatic sternal fractures
  • All patients of all ages and genders are included
  • All types of sternal fractures and manubri-sternal junction dislocation.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Kareem Ahmed Hosny contact

01000401994

kareemdna94@gmail.com

Egypt1 site, 1 recruiting
  • Assiut university heart hospital

    Asyut, 2112

    Kareem Ahmed Hosny, Bachelor of medicine, 01000401994, kareemdna94@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Sternal Fracture Fixation by Locking Compression Plates (LCP) System

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.

Read the 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.

Being tested
Locking compression plates

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Locking compression platesProcedure or surgery

    Fixation of sternal fracture using locking compression mechanism

Study groups in NCT04092374
Study groupRoleWhat they receive
Case armExperimentalNot described
Receives: Procedure: Locking compression plates

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post operative pain: score

    Pain score for post operative period in patients using locking compression plates.

    Measured: Early post operative period up to one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2019
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04092374
Sponsor's protocol ID
AssiutUniv
Acronym
aun
Status last verified
Sep 2019
First submitted
14 Sep 2019
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32825827

Questions about this trial

What is this clinical trial studying?

A study testing Locking compression plates in people with Sternal Fracture, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kareem Ahmed Hosny (01000401994, kareemdna94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post operative pain: score (time frame: Early post operative period up to one week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04092374, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.

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