Results of Flexor Tendon Repair of the Hand in Children Below Six Years of Age
1 other identifier
interventional
30
0 countries
N/A
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
December 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedDecember 23, 2020
December 1, 2020
1.8 years
September 24, 2020
December 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
children below six years
ACTIVE COMPARATORchildren below sex years both genders
cooperative children
ACTIVE COMPARATORrepair of the tendos by modified kessler
Interventions
4 strand technique reapir of tendin flexor injury
Eligibility Criteria
You may qualify if:
- Acute flexor tendon injuries of the hand in both genders. All flexor zones are included. Cooperative patients aged between 0-6 years.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
PMID: 30969257BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
September 24, 2020
First Posted
October 8, 2020
Study Start
December 25, 2020
Primary Completion
October 1, 2022
Study Completion
October 1, 2023
Last Updated
December 23, 2020
Record last verified: 2020-12