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

Flexor Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04579809
• Other study ID #: Flexor tendon repair in child
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 25, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: December 2020
• Source: Assiut University
• Contact: andrew nakhla, resident
• Phone: 01273393755
• Email: andrewnakhla05[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Flexor Tendon Rupture
• Rupture

Intervention

Procedure:
• 4 strand technique
4 strand technique reapir of tendin flexor injury

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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