Distal Radius FractureNCT07162142
Retrograde Elastic Nailing With Pollar K-wire in Metaphyseal Diaphyseal Fracture of Distal Radius in Pediatric Patients
A study testing elastic nailing with pollar K.wire in people with Distal Radius Fracture, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Distal radius fractures are the most common fractures in the pediatric population . It accounts for 35% of all pediatric fractures . Although pediatric distal radius fractures can be successfully treated conservatively, reduction losses of 21-39% can be observed in the treatment with a plaster cast . Read more about this study
- Who is it for?
- Ages 2 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- elastic nailing with pollar K.wire
- 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
- 1 Dec 2024to 30 Dec 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 2 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- all distal radial fractures in pediatric patients 3-15 years failed closed reduction
Who cannot join
- pathological fracture
Trial locations and contacts
1 site in 1 country.
About this study
Distal radius fractures are the most common fractures in the pediatric population . It accounts for 35% of all pediatric fractures . Although pediatric distal radius fractures can be successfully treated conservatively, reduction losses of 21-39% can be observed in the treatment with a plaster cast . Reduction losses are frequently observed in distal radius diaphyseal metaphyseal junctional (DRDMJ) fractures, primarily due to the limited contact surface of the fracture . There has yet to be a consensus regarding the treatment protocol for DRDMJ fractures . In DRDMJ fractures, surgery is recommended in cases where satisfactory alignment cannot be achieved with closed re-duction and cast immobilization, or there is reduction loss in clinical follow-ups .
- Conditions
- Distal Radius Fracture
- Being tested
- elastic nailing with pollar K.wire
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastic nailing with pollar K.wireProcedure or surgery
retrograde elastic nailing of metaphyseal diaphyseal fracture of distal radius in pediatrics
| Study group | Role | What they receive |
|---|---|---|
| metaphyseal diaphyseal fracture of distal radial fracture in pediatrics | Experimental | Not described Receives: Procedure: elastic nailing with pollar K.wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Dec 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdalaziz youssef mohammed abdalhady, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162142
- Sponsor's protocol ID
- RENPKMDFDRP
- Status last verified
- Aug 2025
- First submitted
- 8 Feb 2025
- Last updated
- 9 Sep 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Elastic Nailing With Pollar K-wire in Metaphyseal Diaphyseal Fracture of Distal Radius in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07162142
- Acronym / sponsor ID
- RENPKMDFDRP
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Sep 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.
Distal radius fractures are the most common fractures in the pediatric population . It accounts for 35% of all pediatric fractures . Although pediatric distal radius fractures can be successfully treated conservatively, reduction losses of 21-39% can be observed in the treatment with a plaster cast . Reduction losses are frequently observed in distal radius diaphyseal metaphyseal junctional (DRDMJ) fractures, primarily due to the limited contact surface of the fracture . There has yet to be a consensus regarding the treatment protocol for DRDMJ fractures . In DRDMJ fractures, surgery is recommended in cases where satisfactory alignment cannot be achieved with closed re-duction and cast immobilization, or there is reduction loss in clinical follow-ups .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metaphyseal diaphyseal fracture of distal radial fracture in pediatrics | Experimental | Procedure: elastic nailing with pollar K.wire |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all distal radial fractures in pediatric patients 3-15 years failed closed reduction
Key exclusion criteria (1 listed)
- pathological 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 |
|---|---|---|
| elastic nailing with pollar K.wireretrograde elastic nailing of metaphyseal diaphyseal fracture of distal radius in pediatrics | Procedure or surgery | metaphyseal diaphyseal fracture of distal radial fracture in pediatrics |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
Time frame: three months
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 9 Sep 2025.
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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 elastic nailing with pollar K.wire in people with Distal Radius Fracture, run by Al-Azhar 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 1 inclusion and 1 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 9 Sep 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?
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks (time frame: three 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 9 Sep 2025.