Pediatric FracturesNCT06891027
Loss of Parental Workforce in Paediatric Fractures
An observational study of Pediatric Fractures and Lower Extremity Fractures, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Childhood fractures are frequently encountered in orthopaedic practice. 40-64% of boys and 25-40% of girls have at least one fracture by the age of 16. Children, who are more fragile than adults, usually require additional care support during the treatment process. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Fractures, Lower Extremity Fractures, Upper Extremity Fractures
- How many people
- 203 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2024to 30 Apr 2025
- How long will I take part?
- 6 Months
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Parents of patients aged <18 years who were admitted to Ankara Etlik City Hospital Emergency Orthopaedics and Traumatology Outpatient Clinic and other Orthopaedics and Traumatology Outpatient Clinics and underwent plaster splinting due to any extremity fracture
Who may be able to join
- patients <18 years of age who underwent plaster splinting for any extremity fracture
Who cannot join
- Parents of patients aged >18 years
- Parents of patients undergoing surgical treatment
- Parents of patients whose initial diagnosis or follow-up was performed at an external centre
- Patients with one parent not working (patients with one working parent will be excluded)
- Parents of patients who did not want to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06170
About this study
Childhood fractures are frequently encountered in orthopaedic practice. 40-64% of boys and 25-40% of girls have at least one fracture by the age of 16. Children, who are more fragile than adults, usually require additional care support during the treatment process. Labour force statistics have determined that one third of the loss of labour force occurs after musculoskeletal injuries.
When the literature is examined, there are many studies investigating loss of labour force after fractures. It was found that 20% of the patients never returned to work after distal radius fracture and the average loss of labour force was 9.2 weeks. In another study, while the return to work period was 60 days in minor hand injuries, it was reported that the return to work could increase to 360 days in major hand injuries. In another study, the average return to work time in patients aged >50 years with fragility fractures was found to be 20.5 days. The rate of return to work after traumatic spinal fracture was found to be only 38.1%.
In daily practice, the investigators observe that parents frequently do not go to work for child care after child fractures. However, there is no similar study investigating this loss of labour force after pediatric fractures in the literature. In this study, the investigators aimed to investigate the loss of parental labour force (LWL) in conservatively followed pediatric fractures
- Keywords
- pediatric fracture, parental workforce, loss of workforce
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pediatric fracture | all paediatric (<18 years) patients presenting with a fracture will be included in the study. parents of patients presenting with a fracture will be informed about the study and parents who are willing to participate in the study will be included. parents will be given a form indicating various workforce losses (including housework and social life) at the first application. this form will be received from the parents at the end of treatment. study data will be collected on this form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of Parental Workforce Questionnaire
A questionnaire called "Loss of Parental Workforce Questionnaire" will be used to evaluate the parental workforce loss. Also with this questionnaire the effect of treatment choice (conservative or surgical) to parental workforce loss will be assessed.
Measured: from first presentation after fracture to the end of treatment (approximately 6 weeks in conservative cases, 3 months in surgical treatments)
Secondary outcomes (1)
Children's Return to School Time
"Loss of Parental Workforce Questionnaire" will also be used to assess Children's Return to School Time.
Measured: from first presentation after fracture to the end of treatment (approximately 6 weeks in conservative cases, 3 months in surgical treatments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start20 Nov 2024
- Primary completion10 Jan 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric FracturesStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Prospective
- Enrolment
- 203 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Berkay Girgin, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891027
- Sponsor's protocol ID
- AEŞH-BADEK-2024-1169
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loss of Parental Workforce in Paediatric Fractures
- ClinicalTrials.gov ID
- NCT06891027
- Acronym / sponsor ID
- AEŞH-BADEK-2024-1169
- Keywords
- pediatric fracture, parental workforce, loss of workforce
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 24 Mar 2025 (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.
Childhood fractures are frequently encountered in orthopaedic practice. 40-64% of boys and 25-40% of girls have at least one fracture by the age of 16. Children, who are more fragile than adults, usually require additional care support during the treatment process. Labour force statistics have determined that one third of the loss of labour force occurs after musculoskeletal injuries.
When the literature is examined, there are many studies investigating loss of labour force after fractures. It was found that 20% of the patients never returned to work after distal radius fracture and the average loss of labour force was 9.2 weeks. In another study, while the return to work period was 60 days in minor hand injuries, it was reported that the return to work could increase to 360 days in major hand injuries. In another study, the average return to work time in patients aged >50 years with fragility fractures was found to be 20.5 days. The rate of return to work after traumatic spinal fracture was found to be only 38.1%.
In daily practice, the investigators observe that parents frequently do not go to work for child care after child fractures. However, there is no similar study investigating this loss of labour force after pediatric fractures in the literature. In this study, the investigators aimed to investigate the loss of parental labour force (LWL) in conservatively followed pediatric fractures
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric fracture | – | –all paediatric (<18 years) patients presenting with a fracture will be included in the study. parents of patients presenting with a fracture will be informed about the study and parents who are willing to participate in the study will be included. parents will be given a form indicating various workforce losses (including housework and social life) at the first application. this form will be received from the parents at the end of treatment. study data will be collected on this form. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Parents of patients aged <18 years who were admitted to Ankara Etlik City Hospital Emergency Orthopaedics and Traumatology Outpatient Clinic and other Orthopaedics and Traumatology Outpatient Clinics and underwent plaster splinting due to any extremity fracture
Key inclusion criteria (1 listed)
- patients <18 years of age who underwent plaster splinting for any extremity fracture
Key exclusion criteria (5 listed)
- Parents of patients aged >18 years
- Parents of patients undergoing surgical treatment
- Parents of patients whose initial diagnosis or follow-up was performed at an external centre
- Patients with one parent not working (patients with one working parent will be excluded)
- Parents of patients who did not want to participate in 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.
Primary outcome
Loss of Parental Workforce Questionnaire
Time frame: from first presentation after fracture to the end of treatment (approximately 6 weeks in conservative cases, 3 months in surgical treatments)
A questionnaire called "Loss of Parental Workforce Questionnaire" will be used to evaluate the parental workforce loss. Also with this questionnaire the effect of treatment choice (conservative or surgical) to parental workforce loss will be assessed.
1 secondary outcome
Children's Return to School Time
Time frame: from first presentation after fracture to the end of treatment (approximately 6 weeks in conservative cases, 3 months in surgical treatments)
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 4 May 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pediatric Fractures and Lower Extremity Fractures, run by Ankara Etlik City Hospital 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 5 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 4 May 2025. 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?
Loss of Parental Workforce Questionnaire (time frame: from first presentation after fracture to the end of treatment (approximately 6 weeks in conservative cases, 3 months in surgical treatments)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2025.