- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04486053
Long-term Results of Pediatric Flexor Tendon Injuries
March 15, 2021 updated by: Marmara University
Effect of Hand Dominance on Functional Outcomes in Pediatric Patients With Flexor Tendon Injuries
Hand and upper extremity injuries are among the most common causes of admission of children to the emergency department since they are the most frequently injured part of body following head in pediatric and adolescent population.
Although upper extremity fractures and contusions are the main reasons of pediatric hand injuries, tendon injuries are not also uncommon.
There are limited data in the literature about the long-term results of children with flexor tendon injury.
Therefore, the aim of this study was to evaluate the long-term functional outcomes of children with flexor tendon injury.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hand and upper extremity injuries are among the most common causes of admission of children to the emergency department since they are the most frequently injured part of body following head in pediatric and adolescent population.
Although upper extremity fractures and contusions are the main reasons of pediatric hand injuries, tendon injuries are not also uncommon.
While extensor tendon injuries have been reported to be most frequent than flexor tendon injuries for all age groups, the ratio of flexor to extensor tendon injuries is higher in pediatric population than adults and in children younger than 10 years old flexor tendon injuries are more common than extensor tendon injuries.Despite some challenges in the treatment of flexor tendon injuries of children, the outcomes have been reported to be better in children than adults since they have better blood supply, more rapid tendon healing and better remodeling ability of scars and adhesions.
However, there is still a risk of permanent morbidities such as significant scarring and stiffness which can cause worse functional outcomes.There are limited data in the literature about the long-term results of children with flexor tendon injury.
Therefore, the aim of this study was to evaluate the long-term functional outcomes of children with flexor tendon injury.
Study Type
Observational
Enrollment (Actual)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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In The USA Or Canada, Please Select...
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İstanbul, In The USA Or Canada, Please Select..., Turkey, 34899
- Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with flexor tendon injury
Description
Inclusion Criteria:
- . Patients between the ages of 6-18 who have applied to orthopedics emergency department due to hand injury and have been operated with flexor tendon injury, for the last 3 years
Exclusion Criteria:
- The patients who had history of bilateral hand injury, delayed surgery, accompanying extensor tendon injury and a follow-up less than six months after injury were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with flexor tendon injury
Patients between the ages of 6-18 who have applied to orthopedics emergency department due to hand injury and have been operated with flexor tendon injury, for the last 3 years, were retrospectively scanned from hospital record.
Eligible patients for the study were informed about the study by telephone and requested to come hospital for further evaluations including sensory, motor and functional assessments.
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The patients who agreed to participate to the study were assessed with a survey which included age, gender, height, weight and hand dominancy questions.
Sensory, motor and functional assessments of the bilateral hand were performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jebson Taylor Hand Function test
Time Frame: Day 0
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Jebsen - Taylor Hand Function Test (JTHFT) was performed on both hands for evaluation of the fine and gross motor functions.
It is a standard and objective assessment method of hand functions with activities similar to those performed in daily life.
The test consists of 7 subtests.
During the test, a separate period is kept for each step.
The functions of both hands are evaluated by the following operations; writing, card turning, picking up small common objects, simulated feeding, stacking backgammon-checkers, moving large light objects and moving large heavy objects.
Score of each subset is time (seconds) to complete the task and total score is calculated by summing of times for each sub-tests
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Day 0
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Grip strength
Time Frame: Day 0
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The grip strength measured using a Baseline Hydraulic Hand Dynamometer according to the recommendations of the American Hand Therapists Association..
It was measured with the shoulder in the adduction, elbow 90 * flexion, forearm neutral and wrist 0-30 * dorsiflexion and 0-15 * ulnar deviation while the person was sitting position.
The patient was asked to grasp the dynamometer as tightly as he could.
For each side, 3 applications were made with an interval of 20 seconds and the average of these measurements was taken
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Day 0
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Pinch Strength
Time Frame: Day 0
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Baseline Hydraulic Pinch Gauge was used to measure pinch strength.
The measurement was made in the same position as the grip strength measurement.
The pinch gauge was placed between the tip of thumb and the tip of the index finger and the patient was asked to squeeze as strongly as he could.
For each side, 3 applications were made with an interval of 20 seconds and the average of these measurements was taken
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Day 0
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Semmes -Weinstein Monofilament test
Time Frame: Day 0
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Sensory examination was done with Semmes -Weinstein Monofilament test.
This evaluation was started with the smallest monofilament and larger filaments were applied respectively, the test was stopped in the smallest monofilament the patient felt, and this value was recorded.
Evaluations were made from the distal tips of the 1st and 2nd finger and the palmar surface of the 2nd metacarpophalangeal joint for the median nerve evaluation (monofilament test 1,2,3, respectively), distal tip of the 5th finger, the palmar surface of the 5th metacarpophalangeal joint and hypothenar area (monofilament test 4, 5, 6, respectively) for ulnar nerve evaluation.
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Day 0
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Canan Sanal-Toprak, Asst. Prof, Marmara University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lee A, Colen DL, Fox JP, Chang B, Lin IC. Pediatric Hand and Upper Extremity Injuries Presenting to Emergency Departments in the United States: Epidemiology and Health Care-Associated Costs. Hand (N Y). 2021 Jul;16(4):519-527. doi: 10.1177/1558944719866884. Epub 2019 Aug 23.
- Vadivelu R, Dias JJ, Burke FD, Stanton J. Hand injuries in children: a prospective study. J Pediatr Orthop. 2006 Jan-Feb;26(1):29-35. doi: 10.1097/01.bpo.0000189970.37037.59.
- Jeon BJ, Lee JI, Roh SY, Kim JS, Lee DC, Lee KJ. Analysis of 344 Hand Injuries in a Pediatric Population. Arch Plast Surg. 2016 Jan;43(1):71-6. doi: 10.5999/aps.2016.43.1.71. Epub 2016 Jan 15.
- Kim JS, Sung SJ, Kim YJ, Choi YW. Analysis of Pediatric Tendon Injuries in the Hand in Comparison with Adults. Arch Plast Surg. 2017 Mar;44(2):144-149. doi: 10.5999/aps.2017.44.2.144. Epub 2017 Mar 15.
- Vahvanen V, Gripenberg L, Nuutinen P. Flexor tendon injury of the hand in children. A long-term follow-up study of 84 patients. Scand J Plast Reconstr Surg. 1981;15(1):43-8. doi: 10.3109/02844318109103410.
- Nietosvaara Y, Lindfors NC, Palmu S, Rautakorpi S, Ristaniemi N. Flexor tendon injuries in pediatric patients. J Hand Surg Am. 2007 Dec;32(10):1549-57. doi: 10.1016/j.jhsa.2007.08.006.
- Cooper L, Khor W, Burr N, Sivakumar B. Flexor tendon repairs in children: Outcomes from a specialist tertiary centre. J Plast Reconstr Aesthet Surg. 2015 May;68(5):717-23. doi: 10.1016/j.bjps.2014.12.024. Epub 2014 Dec 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 15, 2020
Primary Completion (ACTUAL)
July 15, 2020
Study Completion (ACTUAL)
July 15, 2020
Study Registration Dates
First Submitted
July 22, 2020
First Submitted That Met QC Criteria
July 22, 2020
First Posted (ACTUAL)
July 24, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 17, 2021
Last Update Submitted That Met QC Criteria
March 15, 2021
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2020.443
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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