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

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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Flexor Tendon Rupture
• Intervention / Treatment: Procedure: 4 strand technique

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: andrew nakhla, resident; Phone Number: 01273393755; Email: andrewnakhla05@gmail.com
• Study Contact Backup: Name: mohamed mohamed, doctor; Phone Number: 01005602259; Email: M.morsy@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion of flexor tendon after repair according total active motion criteria	above elbow cast fo four weeks	follow up the patients up to one year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 25, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: Flexor tendon repair in child

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No