Fracture HumerusNOTICENCT05096689
Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures
A study testing MRI in people with Fracture Humerus and Physeal Fracture, run by Children's Fractures Interest Group, Denmark at 1 site in Denmark.
Trial summary
The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the chondral (unossified) epiphysis. MRI gives a perfect view of these fractures. Read more about this study
- Who is it for?
- Ages 2 to 13 years
- Conditions the study is for
- Fracture Humerus, Physeal Fracture
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2021to 1 Oct 2024
- Phase
- Interventional
- 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 2 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of acute Lateral humeral condyle fracture
- Fracture <5 days old
- Fracture with <5 mm of displacement on plain radiographs
- Parental informed consent obtained
Who cannot join
- Contraindication(s) to performing an MRI
- Unable to participate in follow-up
- Existing bone pathology
- Previous ipsilateral elbow fracture
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital - Herlev and Gentofte
Herlev, Capital Region, 2730
Morten J Andersen, MD, 004538681479, morten.jon.andersen@regionh.dk
About this study
Official title: Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures: a Cohort Study of 50 Patients
The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the chondral (unossified) epiphysis. MRI gives a perfect view of these fractures. The safety and feasibility of non-operative treatment based on MRI findings in children with elbow fractures has not been investigated in a Danish setting. If safe and feasible, the use of MRI could dramatically lower the need for surgery in children with LHCF.
Read the detailed description
The treatment of LHCF has historically most often been surgical with open reduction and fixation. The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the unossified chondral epiphysis and therefore physicians often opt for open surgical treatment. MRI; however, gives a perfect view of these fractures. This project investigates the safety and feasibility of non-operative treatment of LHCF based on MRI performed without sedation or anesthesia and seeks to dramatically lower the need for surgery. Objectives are to describe functional outcome, radiological healing, secondary fracture displacement and any complications after two years. The investigators hypothesize that undisplaced and minimally displaced LHCF can be treated non-operatively based on MRI findings with good functional outcomes after two years. A cohort study design is used to follow 50 children with LHCF.
- Conditions
- Fracture Humerus, Physeal Fracture
- Being tested
- MRI
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Magnetic Resonance Imaging
| Study group | Role | What they receive |
|---|---|---|
| Non-operative | Experimental | Non-operative treatment of lateral humeral condyle fractures Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Elbow Performance Score (MEPS)
MEPS consists of three domains; pain, elbow range of motion (ROM) and stability. The total score ranges from 0-100 with higher scores indicating better function. If the total score ranges between 75 and 100, the result is good (satisfactory); 50-74, fair (acceptable); <50, poor (unsatisfactory).
Measured: 2 years
Secondary outcomes (6)
MRI results
Proportion of successful MRIs defined as a completed scan with an image quality that is useful for analysis by the radiologist.
MRI findings. Song classification based on MRI. Scan length (minutes). Any discomforts for the child during the scan.
Measured: 2 weeks
Radiographic results
Injury radiographs and subsequent radiographs during FU will be read and described by a senior orthopedic surgeon.
Measured: 2 years
Secondary fracture displacement
Any secondary displacement and amount of radiographic displacement (mm) is recorded.
Measured: 2 years
Pain scale (age <5 years)
To quantify pain in the patient age <5 years, the Face, Legs, Activity, Cry, Consolability Scale (FLACC). To quantify pain behaviors in children who may not be able to verbalize the presence or severity of pain FLACC provides a simple framework. The child is observed for at least 2-5 minutes. Legs and body are observed uncovered. Activity is observed and body is assessed for tenseness and tone.
Assessment of Behavioural Score: 0 = Relaxed and comfortable. 1-3 = Mild discomfort. 4-6 = Moderate pain. 7-10 = Severe discomfort/pain.
Measured: 2 years
Pain scale (age >4 years)
To quantify pain in the patient >4 years, Faces Pain Scale - Revised (FPS-R) is applied.
The Faces Pain Scale - Revised (FPS-R) is used to quantify pain in children above four years of age. It is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on a 0-to-10 metric. The scale shows a close linear relationship with visual analog pain scales (VAS) across the age range of 4-16 years.
FPS-R is easy to administer and requires no equipment except for the photocopied faces. The child is asked to point to the face that shows how much pain the child is in at that moment. Faces are scored 0-10 so 0 equals no pain and 10 equals very much pain.
Measured: 2 years
Pain scale (age >8 years)
A visual analogue scale (VAS) is used to quantify pain in children age 8 and above. VAS has been extensively investigated in quantifying pain in older children. The child is asked to put a mark on the line corresponding to the child's pain at that moment. A mark to the far left equals no pain and a mark to the far right equals worst possible pain. The line is 10 cm long and the child's mark is measured from left to right in cm with one decimal e.g., 3.4 cm equaling a VAS of 3.4. If the child cannot cooperate to using VAS, FPS-R is used instead.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture HumerusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Cohort, Single center
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Fractures Interest Group, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Jon Andersen, Children's Fractures Interest Group, Denmark
- Investigators
- Morten J Andersen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096689
- Sponsor's protocol ID
- H-21017621
- Acronym
- NOTICE
- Status last verified
- Nov 2021
- First submitted
- 12 Oct 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures: a Cohort Study of 50 Patients
- ClinicalTrials.gov ID
- NCT05096689
- Acronym / sponsor ID
- NOTICE / H-21017621
- Conditions
- Fracture Humerus, Physeal Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Fractures Interest Group, DenmarkUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 27 Oct 2021 (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 diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the chondral (unossified) epiphysis. MRI gives a perfect view of these fractures. The safety and feasibility of non-operative treatment based on MRI findings in children with elbow fractures has not been investigated in a Danish setting. If safe and feasible, the use of MRI could dramatically lower the need for surgery in children with LHCF.
Detailed description
The treatment of LHCF has historically most often been surgical with open reduction and fixation. The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the unossified chondral epiphysis and therefore physicians often opt for open surgical treatment. MRI; however, gives a perfect view of these fractures. This project investigates the safety and feasibility of non-operative treatment of LHCF based on MRI performed without sedation or anesthesia and seeks to dramatically lower the need for surgery. Objectives are to describe functional outcome, radiological healing, secondary fracture displacement and any complications after two years. The investigators hypothesize that undisplaced and minimally displaced LHCF can be treated non-operatively based on MRI findings with good functional outcomes after two years. A cohort study design is used to follow 50 children with LHCF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Cohort, Single center
| Arm | Type | Receives |
|---|---|---|
| Non-operative | Experimental | Other: MRINon-operative treatment of lateral humeral condyle fractures |
Who may qualify
- Ages
- 2 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of acute Lateral humeral condyle fracture
- Fracture <5 days old
- Fracture with <5 mm of displacement on plain radiographs
- Parental informed consent obtained
Key exclusion criteria (4 listed)
- Contraindication(s) to performing an MRI
- Unable to participate in follow-up
- Existing bone pathology
- Previous ipsilateral elbow fracture
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 |
|---|---|---|
| MRIMagnetic Resonance Imaging | Other | Non-operative |
Primary outcome
Mayo Elbow Performance Score (MEPS)
Time frame: 2 years
MEPS consists of three domains; pain, elbow range of motion (ROM) and stability. The total score ranges from 0-100 with higher scores indicating better function. If the total score ranges between 75 and 100, the result is good (satisfactory); 50-74, fair (acceptable); <50, poor (unsatisfactory).
6 secondary outcomes
MRI results
Time frame: 2 weeks
Radiographic results
Time frame: 2 years
Secondary fracture displacement
Time frame: 2 years
Pain scale (age <5 years)
Time frame: 2 years
Pain scale (age >4 years)
Time frame: 2 years
Pain scale (age >8 years)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Morten J Andersen, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Fracture Humerus and Physeal Fracture, run by Children's Fractures Interest Group, Denmark at 1 site in Denmark.
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 4 inclusion and 4 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 11 Nov 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morten J Andersen, MD (004538681479, mortenjonandersen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mayo Elbow Performance Score (MEPS) (time frame: 2 years). 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 11 Nov 2021.