NCT04092374

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

September 14, 2019

Last Update Submit

September 17, 2019

Conditions

Sternal Fracture

Outcome Measures

Primary Outcomes (1)

  • Post operative pain: score

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

    Early post operative period up to one week

Study Arms (1)

Case arm

EXPERIMENTAL
Procedure: Locking compression plates

Interventions

Locking compression platesPROCEDURE

Fixation of sternal fracture using locking compression mechanism

Case arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university heart hospital

Asyut, 2112, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32825827DERIVED

Central Study Contacts

Kareem Ahmed Hosny

CONTACT

01000401994kareemdna94@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Surgeon

Study Record Dates

First Submitted

September 14, 2019

First Posted

September 17, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

EG(1)