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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04486053
Other study ID # 09.2020.443
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2020
Est. completion date July 15, 2020

Study information

Verified date November 2020
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date July 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility 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 Design


Intervention

Other:
Screening
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.

Locations

Country Name City State
Turkey Marmara University School of Medicine Department of Physical Medicine and Rehabilitation Istanbul In The USA Or Canada, Please Select...

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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). 2019 Aug 23:1558944719866884. doi: 10.1177/1558944719866884. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Jebson Taylor Hand Function test 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 Day 0
Primary Grip strength 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 Day 0
Primary Pinch Strength 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 Day 0
Primary Semmes -Weinstein Monofilament test 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. Day 0
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