Fracture of Ulna ShaftNCT06781684
Ulnar Shaft Fracture Fixation by Antegrade Versus Retrograde Intramedullary k Wires in Children
A study testing ulna shaft fracture fixation in children by intramedullary k wire in people with Fracture of Ulna Shaft, run by Sohag University at 1 site in Egypt.
Trial summary
This study is made to see and evaluate the outcomes of treating and fixing ulnar shaft fracture in children by antegrade versus retrograde intramedullary k wires Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Fracture of Ulna Shaft
- What is being tested?
- ulna shaft fracture fixation in children by intramedullary k wire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patient
- aging from 4 to 15 years old
- diaphyseal ulnar fracture
- either isolated or combined with radius fracture (both bone).
Who cannot join
- Segmental fractures
- Montaggia variants
- Gelliazzi fracture
- Fractures associated with radial head fracture - Compound fractures
- Fractures with neurovascular affection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ulnar Shaft Fracture Fixation by Antegrade Versus Retrograde Intramedullary k Wires in Children;A Comparative Study
This study is made to see and evaluate the outcomes of treating and fixing ulnar shaft fracture in children by antegrade versus retrograde intramedullary k wires
Read the detailed description
This study is made on children with ulnar shaft fracture and treating their fracture by intramedullary k wires ,dividing them into two groups ,one of them the child ulnar fracture is reduced and fixed by intramedullary antegrade k wire and the other group the fracture is reduced and fixed by retrograde k wire ,and compare the functional, clinical and radiological outcomes between the two groups
- Conditions
- Fracture of Ulna Shaft
- Being tested
- ulna shaft fracture fixation in children by intramedullary k wire
- Keywords
- Fixation of pediatric ulna shaft fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulna shaft fracture fixation in children by intramedullary k wireProcedure or surgery
- In the 1st group The Antegrade intramedullary k wire with appropriate diameter according to the child ulna diameter is introduced from the olecranon of the fractured ulna,cross the fracture site after good reduction under C arm in the anterioposterior and lateral views and the wire continues until reaching before the distal ulna .
- In the 2nd group The Retrograde intramedullary k wire with appropriate diameter is introduced from the diatal end of the ulna and cross the fracture site after good reduction under C arm and continues until reaching before the olecranon.
| Study group | Role | What they receive |
|---|---|---|
| Antegrade intramedullary k wire group | Active comparator | k wire entry point is from the olecranon towards the hand before the distal ulnar styloid Receives: Procedure: ulna shaft fracture fixation in children by intramedullary k wire |
| Retrograde intramedullary k wire group | Active comparator | k wire entry point is from the distal ulnar styloid towards the olecranon Receives: Procedure: ulna shaft fracture fixation in children by intramedullary k wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of complete union of the bone in every group
Each patient is evaluated radiologically after fixing the fracture by x-ray AP and lateral views after 2 week ,4 ,6 ,12 weeks and 3 months to see the time each one taking to complete union .
-Also clinical and functional evaluation of every patient and timing of ability to use his forearm , ability to do supination and pronation of the forearm , flexion and extension of the elbow and wrist , ability to do ulnar deviation at the level of the wrist and degree of pain and apprehension with each movement ,Degree of pain and tenderness in the fracture site and time taking to complete disappearing of pain and tenderness ,degree of stiffness and need to physiotherapy ,these data is collected from each patient at the time of follow up in the outpatient clinic and recorded for everyone in each group.
Measured: The evaluation is done at 2,4,6 and 12 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Ulna ShaftStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Ali, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781684
- Sponsor's protocol ID
- Soh-Med-24-12-01MS
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulnar Shaft Fracture Fixation by Antegrade Versus Retrograde Intramedullary k Wires in Children;A Comparative Study
- ClinicalTrials.gov ID
- NCT06781684
- Acronym / sponsor ID
- Soh-Med-24-12-01MS
- Conditions
- Fracture of Ulna Shaft
- Keywords
- Fixation of pediatric ulna shaft fracture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 17 Jan 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.
This study is made to see and evaluate the outcomes of treating and fixing ulnar shaft fracture in children by antegrade versus retrograde intramedullary k wires
Detailed description
This study is made on children with ulnar shaft fracture and treating their fracture by intramedullary k wires ,dividing them into two groups ,one of them the child ulnar fracture is reduced and fixed by intramedullary antegrade k wire and the other group the fracture is reduced and fixed by retrograde k wire ,and compare the functional, clinical and radiological outcomes between the two groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antegrade intramedullary k wire group | Active comparator | Procedure: ulna shaft fracture fixation in children by intramedullary k wirek wire entry point is from the olecranon towards the hand before the distal ulnar styloid |
| Retrograde intramedullary k wire group | Active comparator | Procedure: ulna shaft fracture fixation in children by intramedullary k wirek wire entry point is from the distal ulnar styloid towards the olecranon |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patient
- aging from 4 to 15 years old
- diaphyseal ulnar fracture
- either isolated or combined with radius fracture (both bone).
Key exclusion criteria (5 listed)
- Segmental fractures
- Montaggia variants
- Gelliazzi fracture
- Fractures associated with radial head fracture - Compound fractures
- Fractures with neurovascular affection
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 |
|---|---|---|
| ulna shaft fracture fixation in children by intramedullary k wire* In the 1st group The Antegrade intramedullary k wire with appropriate diameter according to the child ulna diameter is introduced from the olecranon of the fractured ulna,cross the fracture site after good reduction under C arm in the anterioposterior and lateral views and the wire continues until reaching before the distal ulna . * In the 2nd group The Retrograde intramedullary k wire with appropriate diameter is introduced from the diatal end of the ulna and cross the fracture site after good reduction under C arm and continues until reaching before the olecranon. | Procedure or surgery | Antegrade intramedullary k wire group, Retrograde intramedullary k wire group |
Primary outcome
The duration of complete union of the bone in every group
Time frame: The evaluation is done at 2,4,6 and 12 weeks and 3 months
Each patient is evaluated radiologically after fixing the fracture by x-ray AP and lateral views after 2 week ,4 ,6 ,12 weeks and 3 months to see the time each one taking to complete union . -Also clinical and functional evaluation of every patient and timing of ability to use his forearm , ability to do supination and pronation of the forearm , flexion and extension of the elbow and wrist , ability to do ulnar deviation at the level of the wrist and degree of pain and apprehension with each movement ,Degree of pain and tenderness in the fracture site and time taking to complete disappearing of pain and tenderness ,degree of stiffness and need to physiotherapy ,these data is collected from each patient at the time of follow up in the outpatient clinic and recorded for everyone in each group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
Related trials for Fracture of Ulna Shaft
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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?
A study testing ulna shaft fracture fixation in children by intramedullary k wire in people with Fracture of Ulna Shaft, 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 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: under way, not looking for participants, as of the sponsor's last update on 17 Jan 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 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?
This study is still under way. Results are not available in the source record yet.
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?
The duration of complete union of the bone in every group (time frame: The evaluation is done at 2,4,6 and 12 weeks and 3 months). 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 17 Jan 2025.