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

NCT ID: NCT04579809

Last Updated: 2020-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-25

Study Completion Date

2023-10-01

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Flexor Tendon Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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children below six years

children below sex years both genders

Group Type ACTIVE_COMPARATOR

4 strand technique

Intervention Type PROCEDURE

4 strand technique reapir of tendin flexor injury

cooperative children

repair of the tendos by modified kessler

Group Type ACTIVE_COMPARATOR

4 strand technique

Intervention Type PROCEDURE

4 strand technique reapir of tendin flexor injury

Interventions

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4 strand technique

4 strand technique reapir of tendin flexor injury

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Andrew Hossny fawzy nakhla

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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andrew nakhla, resident

Role: CONTACT

Phone: 01273393755

Email: [email protected]

mohamed mohamed, doctor

Role: CONTACT

Phone: 01005602259

Email: [email protected]

References

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Piper SL, Wheeler LC, Mills JK, Ezaki M, Oishi SN. Outcomes After Primary Repair and Staged Reconstruction of Zone I and II Flexor Tendon Injuries in Children. J Pediatr Orthop. 2019 May/Jun;39(5):263-267. doi: 10.1097/BPO.0000000000000912.

Reference Type BACKGROUND
PMID: 30969257 (View on PubMed)

Other Identifiers

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Flexor tendon repair in child

Identifier Type: -

Identifier Source: org_study_id