Supracondylar Humerus FractureSUPCONFOLLOWNCT05780398
Long Term Follow up in Pediatric Supracondylar Humeral Fracture
An observational study of Supracondylar Humerus Fracture and Elbow Fracture, run by University Hospital, Grenoble.
Trial summary
The goal of this clinical trial is to learn about long term outcomes in Supracondylar Humeral Fracture in children after surgery. The main questions it aims to answer are: how good is the elbow function what are the post-operative complication what is the time before return to sport what is the aesthetic prejudice of… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Supracondylar Humerus Fracture, Elbow Fracture
- How many people
- 634 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Oct 2024
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children operated for a supracondylar humeral fracture in university hospital of Grenoble from July 2011 to December 2019
Who may be able to join
- Children operated for a supracondylar humeral fracture in university hospital of Grenoble from July 2011 to December 2019
Who cannot join
- Opposition from patient or parents to participate
- Children who did not effectively suffered a supracondylar humeral fracture
About this study
Official title: Long Term Follow up in Pediatric Supracondylar Humeral Fracture After Surgical Treatment
The goal of this clinical trial is to learn about long term outcomes in Supracondylar Humeral Fracture in children after surgery.
The main questions it aims to answer are:
- how good is the elbow function
- what are the post-operative complication
- what is the time before return to sport
- what is the aesthetic prejudice of the scar for the patient Participants will answer questionnaries and send photographs of their elbows to the examinator
Read the detailed description
Elbow fractures represent 5% of total fracture in children. Supracondylar humeral fractures compound half of them.
As distal humerus is responsible for only 20% of humeral growth, bone remodelage her is less important compared to other sites in children..
Many different attitudes are possible : orthopedic reduction, open reduction, percutaneous pinning ... No methode as clearly demontrated a superiority.
Percutaneous pinning as been widely used the last years though We haven't find any study evaluating long term outcomes regarding functionnal and aesthetic outcomes in supracondylar humeral fracture treated by percutaneous pinning.
- Conditions
- Supracondylar Humerus Fracture, Elbow Fracture
- Keywords
- long term follow up
- Medical subject headings
- Elbow Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome after supracondylar humeral fracture
Pediatric-Adolescent Shoulder and Elbow Survey (PEDI ASES), rate from 0 to 84, 0 is poor and 84 is excellent
Measured: 1 day
functional outcome after supracondylar humeral fracture
FLYNN'S CRITERIA
Measured: 1 day
functional outcome after supracondylar humeral fracture
range of motion mesured in degrees
Measured: 1 day
Secondary outcomes (3)
post operative complication
identify number and type of complication
Measured: 1 day
time before return to sport
time in days before return to sport
Measured: 1 day
aesthetical prejudice
The Patient and Observer Scar Assement Scale (POSAS), rate from 7 to 70, 7 is excellent and 70 is poor
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supracondylar Humerus FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 634 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780398
- Sponsor's protocol ID
- 38RC22.0384
- Acronym
- SUPCONFOLLOW
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up in Pediatric Supracondylar Humeral Fracture After Surgical Treatment
- ClinicalTrials.gov ID
- NCT05780398
- Acronym / sponsor ID
- SUPCONFOLLOW / 38RC22.0384
- Conditions
- Supracondylar Humerus Fracture, Elbow Fracture
- Keywords
- long term follow up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 634 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 22 Mar 2023 (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.
The goal of this clinical trial is to learn about long term outcomes in Supracondylar Humeral Fracture in children after surgery.
The main questions it aims to answer are:
- how good is the elbow function
- what are the post-operative complication
- what is the time before return to sport
- what is the aesthetic prejudice of the scar for the patient Participants will answer questionnaries and send photographs of their elbows to the examinator
Detailed description
Elbow fractures represent 5% of total fracture in children. Supracondylar humeral fractures compound half of them.
As distal humerus is responsible for only 20% of humeral growth, bone remodelage her is less important compared to other sites in children..
Many different attitudes are possible : orthopedic reduction, open reduction, percutaneous pinning ... No methode as clearly demontrated a superiority.
Percutaneous pinning as been widely used the last years though We haven't find any study evaluating long term outcomes regarding functionnal and aesthetic outcomes in supracondylar humeral fracture treated by percutaneous pinning.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children operated for a supracondylar humeral fracture in university hospital of Grenoble from July 2011 to December 2019
Key inclusion criteria (1 listed)
- Children operated for a supracondylar humeral fracture in university hospital of Grenoble from July 2011 to December 2019
Key exclusion criteria (2 listed)
- Opposition from patient or parents to participate
- Children who did not effectively suffered a supracondylar humeral fracture
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
functional outcome after supracondylar humeral fracture
Time frame: 1 day
Pediatric-Adolescent Shoulder and Elbow Survey (PEDI ASES), rate from 0 to 84, 0 is poor and 84 is excellent
functional outcome after supracondylar humeral fracture
Time frame: 1 day
FLYNN'S CRITERIA
functional outcome after supracondylar humeral fracture
Time frame: 1 day
range of motion mesured in degrees
3 secondary outcomes
post operative complication
Time frame: 1 day
time before return to sport
Time frame: 1 day
aesthetical prejudice
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Supracondylar Humerus Fracture and Elbow Fracture, run by University Hospital, Grenoble.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
functional outcome after supracondylar humeral fracture (time frame: 1 day). The study lists 3 primary outcomes in all. 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 22 Mar 2023.