Lateral Condyle Humerus Fracture in ChildrenNCT05409053
Kirschner Wires Fixation Versus Cannulated Screws Internal Fixation for Displaced Lateral Condyle Humeral Fracture in Children
A study testing open reduction, Closed reduction and Conservative management in people with Lateral Condyle Humerus Fracture in Children, run by Sohag University at 1 site in Egypt.
Trial summary
Lateral condyle fracture of the distal humerus is the second most common injury around the elbow and accounts for 20% of all the elbow fractures in children.The average age for the fracture involving the lateral condyle is around six years. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Lateral Condyle Humerus Fracture in Children
- What is being tested?
- open reduction, Closed reduction and Conservative management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2022to Nov 2023
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children up to 14 years.
- closed lateral condylar fracture.
- displacement more than 2mm .
- fracture Less than two weeks of injury.
Who cannot join
- Patients with open fractures.
- otherassociated injury in the same elbow .
- elbow with preexisting anatomical deformity .
Trial locations and contacts
1 site in 1 country.
El-shazly s mousa, professor contact
About this study
Official title: Open Reduction and Kirschner Wires Fixation Versus Cannulated Screws Internal Fixation for Displaced Lateral Condyle Humeral Fracture in Children. Randomized Controlled Trial.
Lateral condyle fracture of the distal humerus is the second most common injury around the elbow and accounts for 20% of all the elbow fractures in children.The average age for the fracture involving the lateral condyle is around six years.
There are different treatment options of the lateral condyle fractures include
- non-operative management with plaster cast immobilization for undisplaced or minimally displaced fractures.
- Whereas the fractures displaced >2 mm need operative management. The objective of treatment in the displaced fracture is to obtain and maintain the articular congruity.
In the operative management, the reduction technique includes open or closed methods.
- Being tested
- open reduction, Closed reduction, Conservative management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open reductionProcedure or surgery
the displaced fractures will be treated with open reduction so as to achieve the near anatomical alignment
Closed reductionProcedure or surgery
the non displaced fractures will be treated with closed reduction and percutaneous pinning
Conservative managementOther
the non displaced fractures will be treated with closed reduction and castor slab
| Study group | Role | What they receive |
|---|---|---|
| screw fixation | Active comparator | lateral condyle humerus fracture open reduction and internal fixation by canullated screws Receives: Procedure: open reduction |
| k wire fixation | Active comparator | lateral condyle humerus fracture open reduction and internal fixation by K wire Receives: Procedure: open reduction |
| Conservative management | Other | Undisplaced fractured treated conservatively by above elbow slab Receives: Other: Conservative management |
| Closed reduction and percutaneous pinning | Other | Undisplaced fractured treated closed reduction and percutaneous pinning Receives: Procedure: Closed reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of union
Follow up radiographs will be requested at immediate postoperative 2, 4, 6, 12 and 24 weeks postoperative to assess healing
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lateral Condyle Humerus Fracture in ChildrenStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassam Abdelrahim Abdelbasset, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409053
- Sponsor's protocol ID
- soh-Med-22-03-08
- Status last verified
- Jun 2022
- First submitted
- 16 Mar 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Franks D, Shatrov J, Symes M, Little DG, Cheng TL. Cannulated screw versus Kirschner-wire fixation for Milch II lateral condyle fractures in a paediatric sawbone model: a biomechanical comparison. J Child Orthop. 2018 Feb 1;12(1):29-35. doi: 10.1302/1863-2548.12.170090.
PubMed 29456751Justus C, Haruno LS, Riordan MK, Wilsford L, Smith T, Antekeier S, McKay SD. Closed and Open Reduction of Displaced Pediatric Lateral Condyle Humeral Fractures, a Study of Short-Term Complications and Postoperative Protocols. Iowa Orthop J. 2017;37:163-169.
PubMed 28852352Cardona JI, Riddle E, Kumar SJ. Displaced fractures of the lateral humeral condyle: criteria for implant removal. J Pediatr Orthop. 2002 Mar-Apr;22(2):194-7.
PubMed 11856929Baharuddin M, Sharaf I. Screw osteosynthesis in the treatment of fracture lateral humeral condyle in children. Med J Malaysia. 2001 Dec;56 Suppl D:45-7.
PubMed 14569766
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Reduction and Kirschner Wires Fixation Versus Cannulated Screws Internal Fixation for Displaced Lateral Condyle Humeral Fracture in Children. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05409053
- Acronym / sponsor ID
- soh-Med-22-03-08
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 8 Jun 2022 (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.
Lateral condyle fracture of the distal humerus is the second most common injury around the elbow and accounts for 20% of all the elbow fractures in children.The average age for the fracture involving the lateral condyle is around six years.
There are different treatment options of the lateral condyle fractures include
- non-operative management with plaster cast immobilization for undisplaced or minimally displaced fractures.
- Whereas the fractures displaced >2 mm need operative management. The objective of treatment in the displaced fracture is to obtain and maintain the articular congruity.
In the operative management, the reduction technique includes open or closed methods.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| screw fixation | Active comparator | Procedure: open reductionlateral condyle humerus fracture open reduction and internal fixation by canullated screws |
| k wire fixation | Active comparator | Procedure: open reductionlateral condyle humerus fracture open reduction and internal fixation by K wire |
| Conservative management | Other | Other: Conservative managementUndisplaced fractured treated conservatively by above elbow slab |
| Closed reduction and percutaneous pinning | Other | Procedure: Closed reductionUndisplaced fractured treated closed reduction and percutaneous pinning |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children up to 14 years.
- closed lateral condylar fracture.
- displacement more than 2mm .
- fracture Less than two weeks of injury.
Key exclusion criteria (3 listed)
- Patients with open fractures.
- otherassociated injury in the same elbow .
- elbow with preexisting anatomical deformity .
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 |
|---|---|---|
| open reductionthe displaced fractures will be treated with open reduction so as to achieve the near anatomical alignment | Procedure or surgery | k wire fixation, screw fixation |
| Closed reductionthe non displaced fractures will be treated with closed reduction and percutaneous pinning | Procedure or surgery | Closed reduction and percutaneous pinning |
| Conservative managementthe non displaced fractures will be treated with closed reduction and castor slab | Other | Conservative management |
Primary outcome
Time of union
Time frame: 6 Months
Follow up radiographs will be requested at immediate postoperative 2, 4, 6, 12 and 24 weeks postoperative to assess healing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Background: PubMed 29456751Franks D, Shatrov J, Symes M, Little DG, Cheng TL. Cannulated screw versus Kirschner-wire fixation for Milch II lateral condyle fractures in a paediatric sawbone model: a biomechanical comparison. J Child Orthop. 2018 Feb 1;12(1):29-35. doi: 10.1302/1863-2548.12.170090.
- Background: PubMed 28852352Justus C, Haruno LS, Riordan MK, Wilsford L, Smith T, Antekeier S, McKay SD. Closed and Open Reduction of Displaced Pediatric Lateral Condyle Humeral Fractures, a Study of Short-Term Complications and Postoperative Protocols. Iowa Orthop J. 2017;37:163-169.
- Background: PubMed 11856929Cardona JI, Riddle E, Kumar SJ. Displaced fractures of the lateral humeral condyle: criteria for implant removal. J Pediatr Orthop. 2002 Mar-Apr;22(2):194-7.
- Background: PubMed 14569766Baharuddin M, Sharaf I. Screw osteosynthesis in the treatment of fracture lateral humeral condyle in children. Med J Malaysia. 2001 Dec;56 Suppl D:45-7.
- Individual participant dataSharing planned: Yes
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.
El-shazly s mousa, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open reduction, Closed reduction and Conservative management in people with Lateral Condyle Humerus Fracture in Children, run by Sohag University at 1 site in Egypt.
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 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 8 Jun 2022. 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 Egypt. 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 bassam A abdalraheem, resident (01099392948, bssam011067@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of union (time frame: 6 Months). 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 NCT05409053, which also lists 4 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 8 Jun 2022.