Fractures, BoneNCT06454929
Treatment of Displaced Medial Epicondyle Fractures In Children
A study testing operative and non-operative in people with Fractures, Bone, run by Assiut University.
Trial summary
Compare the outcome of the operative and non-operative treatment; for fractures of the medial epicondyle of humerus in children as regards union, alignment and complications. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- operative and non-operative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Jul 2026
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients Age < 16 years presenting with a ≥2 mm displaced non-incarcerated medial epicondyle fracture with or without concomitant elbow dislocation and normal ulnar nerve function.
- Acute fractures were defined as less than7 days between the date of injury and initiation of treatment
Who cannot join
- systemic bone disease
- concomitant fracture or injury of the same upper limb requiring operative intervention
- Open fractures, incarceration of the fragment inside the joint or ulnar nerve dysfunction require surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Operative And Non-operative Treatment of Displaced Medial Epicondyle Fractures In Children
Compare the outcome of the operative and non-operative treatment; for fractures of the medial epicondyle of humerus in children as regards union, alignment and complications.
Read the detailed description
On the distal humerus, posteromedially, is where the medial epicondyle apophysis is situated. It serves as the starting point for the flexor-pronator muscle and the ulnar collateral ligament. 12-20% of pediatric elbow fractures have been reported to be caused by fractures of the medial humeral epicondyle. Thirty to fifty percent of these fractures result in elbow dislocation, and eighteen to twenty percent of the fracture fragments become lodged in the elbow joint. The medial epicondyle fractures typically happen between the ages of 9 and 14 due to the insufficient ossification of the bone, which makes it more prone to failure early than the stronger soft-tissue attachments.
Optimal treatment for pediatric medial epicondyle fractures continues to be a topic of debate.
In the face of technical advancements, evolving surgical indications, and societal pressures, there is little concrete data demonstrating the superiority of either operative or non-operative treatment.
When a child's medial humeral epicondyle fracture is minimally displaced (less than 2 mm), non-operative therapy is recommended. The PedsQL Pediatric discomfort Questionnaire revealed that children who received non-operative treatment experienced reduced discomfort (3 vs. 15, p = 0.01) and had superior cosmetic results. There is a great deal of disagreement about how to treat displaced fractures (3-15 mm), with some surgeons supporting internal fixation as the non-union rate drops significantly. For upper-extremity athletes who need elbow stability to play their sport, surgery is also advised. Furthermore, it has been proposed that there are no statistically significant variations in outcomes between surgical and non-operative groups.
Fractures of the medial humeral epicondyle in children heal well with 3-4 weeks' immobilization. There is no common consensus in treatment of closed medial epicondyle fractures with >2 mm displacement (without incarceration of the fragment inside the joint or ulnar nerve dysfunction) that Open reduction and screw fixation improve outcome.
The purpose of our study is to compare the treatment outcomes and complications between operatively and non-operatively treated displaced medial epicondyle fractures. We aim to improve our understanding of the outcomes of these fractures to make treatment recommendations. We hypothesise that there is no difference in treatment outcomes between non-operative and operative treatment.
- Conditions
- Fractures, Bone
- Being tested
- operative, non-operative
- Keywords
- medial epicondyle fracture
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operativeProcedure or surgery
open reduction : fixation by k-wires or screws
non-operativeProcedure or surgery
close reduction : by cast Immobilization
| Study group | Role | What they receive |
|---|---|---|
| operative group | Active comparator | fixation by k-wires or screws Receives: Procedure: operative |
| non operative group | Active comparator | fixation by cast immobilisation Receives: Procedure: non-operative |
What is being measured
The primary outcome is the main question the study is designed to answer.
The disabilities of the arm, shoulder and hand (QuickDASH) score
QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- operative by k-wires or screws or non-operative by cast immobilisation treatment (using randomization tables/software
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ezzat mohamed eltaweel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454929
- Sponsor's protocol ID
- Medial Epicondyle Fracture
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pathy R, Dodwell ER. Medial epicondyle fractures in children. Curr Opin Pediatr. 2015 Feb;27(1):58-66. doi: 10.1097/MOP.0000000000000181.
PubMed 25564187Beck JJ, Bowen RE, Silva M. What's New in Pediatric Medial Epicondyle Fractures? J Pediatr Orthop. 2018 Apr;38(4):e202-e206. doi: 10.1097/BPO.0000000000000902.
PubMed 27861213Axibal DP, Carry P, Skelton A, Mayer SW. No Difference in Return to Sport and Other Outcomes Between Operative and Nonoperative Treatment of Medial Epicondyle Fractures in Pediatric Upper-Extremity Athletes. Clin J Sport Med. 2020 Nov;30(6):e214-e218. doi: 10.1097/JSM.0000000000000666.
PubMed 30277893
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Operative And Non-operative Treatment of Displaced Medial Epicondyle Fractures In Children
- ClinicalTrials.gov ID
- NCT06454929
- Acronym / sponsor ID
- Medial Epicondyle Fracture
- Conditions
- Fractures, Bone
- Keywords
- medial epicondyle fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 Jun 2024 (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.
Compare the outcome of the operative and non-operative treatment; for fractures of the medial epicondyle of humerus in children as regards union, alignment and complications.
Detailed description
On the distal humerus, posteromedially, is where the medial epicondyle apophysis is situated. It serves as the starting point for the flexor-pronator muscle and the ulnar collateral ligament. 12-20% of pediatric elbow fractures have been reported to be caused by fractures of the medial humeral epicondyle. Thirty to fifty percent of these fractures result in elbow dislocation, and eighteen to twenty percent of the fracture fragments become lodged in the elbow joint. The medial epicondyle fractures typically happen between the ages of 9 and 14 due to the insufficient ossification of the bone, which makes it more prone to failure early than the stronger soft-tissue attachments.
Optimal treatment for pediatric medial epicondyle fractures continues to be a topic of debate.
In the face of technical advancements, evolving surgical indications, and societal pressures, there is little concrete data demonstrating the superiority of either operative or non-operative treatment.
When a child's medial humeral epicondyle fracture is minimally displaced (less than 2 mm), non-operative therapy is recommended. The PedsQL Pediatric discomfort Questionnaire revealed that children who received non-operative treatment experienced reduced discomfort (3 vs. 15, p = 0.01) and had superior cosmetic results. There is a great deal of disagreement about how to treat displaced fractures (3-15 mm), with some surgeons supporting internal fixation as the non-union rate drops significantly. For upper-extremity athletes who need elbow stability to play their sport, surgery is also advised. Furthermore, it has been proposed that there are no statistically significant variations in outcomes between surgical and non-operative groups.
Fractures of the medial humeral epicondyle in children heal well with 3-4 weeks' immobilization. There is no common consensus in treatment of closed medial epicondyle fractures with >2 mm displacement (without incarceration of the fragment inside the joint or ulnar nerve dysfunction) that Open reduction and screw fixation improve outcome.
The purpose of our study is to compare the treatment outcomes and complications between operatively and non-operatively treated displaced medial epicondyle fractures. We aim to improve our understanding of the outcomes of these fractures to make treatment recommendations. We hypothesise that there is no difference in treatment outcomes between non-operative and operative treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- operative by k-wires or screws or non-operative by cast immobilisation treatment (using randomization tables/software
| Arm | Type | Receives |
|---|---|---|
| operative group | Active comparator | Procedure: operativefixation by k-wires or screws |
| non operative group | Active comparator | Procedure: non-operativefixation by cast immobilisation |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients Age < 16 years presenting with a ≥2 mm displaced non-incarcerated medial epicondyle fracture with or without concomitant elbow dislocation and normal ulnar nerve function.
- Acute fractures were defined as less than7 days between the date of injury and initiation of treatment
Key exclusion criteria (3 listed)
- systemic bone disease
- concomitant fracture or injury of the same upper limb requiring operative intervention
- Open fractures, incarceration of the fragment inside the joint or ulnar nerve dysfunction require surgery
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 |
|---|---|---|
| operativeopen reduction : fixation by k-wires or screws | Procedure or surgery | operative group |
| non-operativeclose reduction : by cast Immobilization | Procedure or surgery | non operative group |
Primary outcome
The disabilities of the arm, shoulder and hand (QuickDASH) score
Time frame: baseline
QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Background: PubMed 25564187Pathy R, Dodwell ER. Medial epicondyle fractures in children. Curr Opin Pediatr. 2015 Feb;27(1):58-66. doi: 10.1097/MOP.0000000000000181.
- Background: PubMed 27861213Beck JJ, Bowen RE, Silva M. What's New in Pediatric Medial Epicondyle Fractures? J Pediatr Orthop. 2018 Apr;38(4):e202-e206. doi: 10.1097/BPO.0000000000000902.
- Background: PubMed 30277893Axibal DP, Carry P, Skelton A, Mayer SW. No Difference in Return to Sport and Other Outcomes Between Operative and Nonoperative Treatment of Medial Epicondyle Fractures in Pediatric Upper-Extremity Athletes. Clin J Sport Med. 2020 Nov;30(6):e214-e218. doi: 10.1097/JSM.0000000000000666.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing operative and non-operative in people with Fractures, Bone, run by Assiut University.
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 2 inclusion and 3 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 29 Jul 2024. 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?
Contact ahmed ezzat M eltaweel, Physician (01068950894 ext. +20, ahmed.15235479@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The disabilities of the arm, shoulder and hand (QuickDASH) score (time frame: baseline). 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 NCT06454929, which also lists 3 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 29 Jul 2024.