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Results of Flexor Tendon Repair of the Hand in Children Below Six Years of Age

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ClinicalTrials.gov Identifier: NCT04579809
Recruitment Status : Not yet recruiting
First Posted : October 8, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew Hossny fawzy nakhla, Assiut University

Study Description
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Brief Summary:
The incidence of flexor tendon injuries in pediatric patients has remained largely undocumented, with a frequency of 3.6 per 100 000 persons per year.The pediatric literature demonstrates a higher prevalence of flexor tendon injuries in men, caused by sharp objects (glass or knife)

Condition or disease Intervention/treatment Phase
Flexor Tendon Rupture Procedure: 4 strand technique Not Applicable

Detailed Description:

The diagnosis of flexor tendon injuries is more challenging in younger children than in adults . and delayed diagnosis in children is common . An innocuous appearing skin wound and a subtle functional deficit may hinder both presentation and identification of the injury.Pediatric flexor tendon injuries heal rapidly and contractures are rare, as long as the joint has not been injured. but Inadequate management can result in loss of hand function .

Data involving children rehabilitation remain unclear, with some studies showing no difference between early rehabilitation protocols and four weeks of cast immobilization . Some studies claim that protocols are not necessary in children younger than six years of age, and that only immobilization is required and some studies show transition to a more aggressive early motion protocol .

Although the incidince of flexor tendon injury in children is not low but the reported cases below the age of six years remains low Which makes reported results less trustworthy. This created the need for a better designed and larger number study to report results in this age group.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective cohort study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Results of Flexor Tendon Repair of the Hand in Children Below Six Yera Sof Age
Estimated Study Start Date : December 25, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: children below six years
children below sex years both genders
 Procedure: 4 strand technique
4 strand technique reapir of tendin flexor injury
Active Comparator: cooperative children
repair of the tendos by modified kessler
 Procedure: 4 strand technique
4 strand technique reapir of tendin flexor injury


Outcome Measures
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Primary Outcome Measures :
  1. range of motion of flexor tendon after repair according total active motion criteria [ Time Frame: follow up the patients up to one year ]
    above elbow cast fo four weeks


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Acute flexor tendon injuries of the hand in both genders. All flexor zones are included. Cooperative patients aged between 0-6 years.

Exclusion Criteria:

  • Uncooperative patients such as psychologically disturbed patients , who will not be able to follow the strict of protocol
  • Age more than six years old .
  • Associated fractures close to the tendon injury.
  • Vascular injury requiring revascularization
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579809


Contacts
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Contact: andrew nakhla, resident 01273393755 andrewnakhla05@gmail.com
Contact: mohamed mohamed, doctor 01005602259 M.morsy@aun.edu.eg

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Andrew Hossny fawzy nakhla, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04579809    
Other Study ID Numbers: Flexor tendon repair in child
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries