Hand InjuriesNCT04486053
Long-term Results of Pediatric Flexor Tendon Injuries
An observational study of Hand Injuries and Flexor Tendon Injury, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries, Flexor Tendon Injury
- What is being tested?
- Screening
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2020to 15 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with flexor tendon injury
Who may be able to join
- . 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, In the USA Or Canada, Please Select..., 34899
About this study
Official title: 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.
Read the 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.
- Conditions
- Hand Injuries, Flexor Tendon Injury
- Being tested
- Screening
- Keywords
- flexor tendons, children, functional outcome, hand injury
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
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
Measured: Day 0
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
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start15 May 2020
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Canan Sanal-Toprak, Asst. Prof, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486053
- Sponsor's protocol ID
- 09.2020.443
- Status last verified
- Nov 2020
- First submitted
- 22 Jul 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31441332Vadivelu 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.
PubMed 16439897Jeon 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.
PubMed 26848449Kim 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.
PubMed 28352603Vahvanen 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.
PubMed 7268311Nietosvaara 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.
PubMed 18070643Cooper 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.
PubMed 25613292
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hand Dominance on Functional Outcomes in Pediatric Patients With Flexor Tendon Injuries
- ClinicalTrials.gov ID
- NCT04486053
- Acronym / sponsor ID
- 09.2020.443
- Conditions
- Hand Injuries, Flexor Tendon Injury
- Keywords
- flexor tendons, children, functional outcome, hand injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with flexor tendon injury | – | Other: ScreeningPatients 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with flexor tendon injury
Key inclusion criteria (1 listed)
- . 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScreeningThe 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. | Other | Patients with flexor tendon injury |
Primary outcome
Jebson Taylor Hand Function test
Time frame: Day 0
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
Grip strength
Time frame: Day 0
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
Pinch Strength
Time frame: Day 0
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
Semmes -Weinstein Monofilament test
Time frame: Day 0
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 31441332Lee 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.
- Background: PubMed 16439897Vadivelu 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.
- Background: PubMed 26848449Jeon 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.
- Background: PubMed 28352603Kim 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.
- Background: PubMed 7268311Vahvanen 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.
- Background: PubMed 18070643Nietosvaara 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.
- Background: PubMed 25613292Cooper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Canan Sanal-Toprak, Asst. Prof principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Injuries and Flexor Tendon Injury, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jebson Taylor Hand Function test (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04486053, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.