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

Primary Purpose

Flexor Tendon Rupture

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

4 strand technique

About this trial

This is an interventional treatment trial for Flexor Tendon Rupture

Eligibility Criteria

1 Day - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

children below six years

cooperative children

Arm Description

children below sex years both genders

repair of the tendos by modified kessler

Outcomes

Primary Outcome Measures

range of motion of flexor tendon after repair according total active motion criteria

above elbow cast fo four weeks

Secondary Outcome Measures

Full Information

NCT ID

NCT04579809

First Posted

September 24, 2020

Last Updated

December 22, 2020

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04579809

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 25, 2020 (Anticipated)

Primary Completion Date

October 1, 2022 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Flexor Tendon Rupture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

prospective cohort study

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

children below six years

Arm Type

Active Comparator

Arm Description

children below sex years both genders

Arm Title

cooperative children

Arm Type

Active Comparator

Arm Description

repair of the tendos by modified kessler

Intervention Type

Procedure

Intervention Name(s)

4 strand technique

Intervention Description

4 strand technique reapir of tendin flexor injury

Primary Outcome Measure Information:

Title

range of motion of flexor tendon after repair according total active motion criteria

Description

above elbow cast fo four weeks

Time Frame

follow up the patients up to one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

andrew nakhla, resident

Phone

01273393755

andrewnakhla05@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

mohamed mohamed, doctor

Phone

01005602259

M.morsy@aun.edu.eg

12. IPD Sharing Statement

Citations:

PubMed Identifier

30969257

Citation

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.

Results Reference

background

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

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