<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04486053</url>
  </required_header>
  <id_info>
    <org_study_id>09.2020.443</org_study_id>
    <nct_id>NCT04486053</nct_id>
  </id_info>
  <brief_title>Long-term Results of Pediatric Flexor Tendon Injuries</brief_title>
  <official_title>Effect of Hand Dominance on Functional Outcomes in Pediatric Patients With Flexor Tendon Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hand and upper extremity injuries are among the most common causes of admission of children&#xD;
      to the emergency department since they are the most frequently injured part of body following&#xD;
      head in pediatric and adolescent population. Although upper extremity fractures and&#xD;
      contusions are the main reasons of pediatric hand injuries, tendon injuries are not also&#xD;
      uncommon. There are limited data in the literature about the long-term results of children&#xD;
      with flexor tendon injury. Therefore, the aim of this study was to evaluate the long-term&#xD;
      functional outcomes of children with flexor tendon injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hand and upper extremity injuries are among the most common causes of admission of children&#xD;
      to the emergency department since they are the most frequently injured part of body following&#xD;
      head in pediatric and adolescent population. Although upper extremity fractures and&#xD;
      contusions are the main reasons of pediatric hand injuries, tendon injuries are not also&#xD;
      uncommon. While extensor tendon injuries have been reported to be most frequent than flexor&#xD;
      tendon injuries for all age groups, the ratio of flexor to extensor tendon injuries is higher&#xD;
      in pediatric population than adults and in children younger than 10 years old flexor tendon&#xD;
      injuries are more common than extensor tendon injuries.Despite some challenges in the&#xD;
      treatment of flexor tendon injuries of children, the outcomes have been reported to be better&#xD;
      in children than adults since they have better blood supply, more rapid tendon healing and&#xD;
      better remodeling ability of scars and adhesions. However, there is still a risk of permanent&#xD;
      morbidities such as significant scarring and stiffness which can cause worse functional&#xD;
      outcomes.There are limited data in the literature about the long-term results of children&#xD;
      with flexor tendon injury. Therefore, the aim of this study was to evaluate the long-term&#xD;
      functional outcomes of children with flexor tendon injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Jebson Taylor Hand Function test</measure>
    <time_frame>Day 0</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Grip strength</measure>
    <time_frame>Day 0</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pinch Strength</measure>
    <time_frame>Day 0</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Semmes -Weinstein Monofilament test</measure>
    <time_frame>Day 0</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">44</enrollment>
  <condition>Hand Injuries</condition>
  <condition>Flexor Tendon Injury</condition>
  <arm_group>
    <arm_group_label>Patients with flexor tendon injury</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening</intervention_name>
    <description>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.</description>
    <arm_group_label>Patients with flexor tendon injury</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with flexor tendon injury&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  . Patients between the ages of 6-18 who have applied to orthopedics emergency&#xD;
             department due to hand injury and have been operated with flexor tendon injury, for&#xD;
             the last 3 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients who had history of bilateral hand injury, delayed surgery, accompanying&#xD;
             extensor tendon injury and a follow-up less than six months after injury were excluded&#xD;
             from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Canan Sanal-Toprak, Asst. Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marmara University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marmara University School of Medicine Department of Physical Medicine and Rehabilitation</name>
      <address>
        <city>İstanbul</city>
        <state>In The USA Or Canada, Please Select...</state>
        <zip>34899</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <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). 2021 Jul;16(4):519-527. doi: 10.1177/1558944719866884. Epub 2019 Aug 23.</citation>
    <PMID>31441332</PMID>
  </reference>
  <reference>
    <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. doi: 10.1097/01.bpo.0000189970.37037.59.</citation>
    <PMID>16439897</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26848449</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28352603</PMID>
  </reference>
  <reference>
    <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. doi: 10.3109/02844318109103410.</citation>
    <PMID>7268311</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/j.jhsa.2007.08.006.</citation>
    <PMID>18070643</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25613292</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>flexor tendons</keyword>
  <keyword>children</keyword>
  <keyword>functional outcome</keyword>
  <keyword>hand injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Tendon Injuries</mesh_term>
    <mesh_term>Hand Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04486053
org study id: 09.2020.443
nct id: NCT04486053
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Jebson Taylor Hand Function test
time frame: Day 0
description: 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
measure: Grip strength
time frame: Day 0
description: 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
measure: Pinch Strength
time frame: Day 0
description: 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
measure: Semmes -Weinstein Monofilament test
time frame: Day 0
description: 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.
arm group label: Patients with flexor tendon injury
description: 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.
intervention type: Other
intervention name: Screening
description: 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.
arm group label: Patients with flexor tendon injury
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Canan Sanal-Toprak, Asst. Prof
role: Principal Investigator
affiliation: Marmara University
facility: 
country: Turkey
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). 2021 Jul;16(4):519-527. doi: 10.1177/1558944719866884. Epub 2019 Aug 23.
PMID: 31441332
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. doi: 10.1097/01.bpo.0000189970.37037.59.
PMID: 16439897
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.
PMID: 26848449
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.
PMID: 28352603
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. doi: 10.3109/02844318109103410.
PMID: 7268311
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. doi: 10.1016/j.jhsa.2007.08.006.
PMID: 18070643
citation: 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.
PMID: 25613292
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Tendon Injuries
mesh term: Hand Injuries