Intramedullary NailDINDPLNCT06542471
Plating Versus Nailing in Pediatric BB Forearm Fractures
A study testing Dual intramedullary nailing and Dual plating in people with Intramedullary Nail and Plate Fixation, run by Ain Shams University at 1 site in Egypt.
Trial summary
A randomized controlled trial to compare between dual intramedullary nailing and dual plating trying to synthesis a high quality evidence study that can solve the conflict between the decisions. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Intramedullary Nail, Plate Fixation, Forearm Fracture
- What is being tested?
- Dual intramedullary nailing and Dual plating
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Sep 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both-bone Forearm Diaphyseal Fracture.
- age more than or equal nine years old with open distal radius physis.
- Simple transverse or short oblique fractures (2R2-A2,2R2-A3,2U2-A2,2U2-A3) according to OTA/ AO classification.
Who cannot join
- Neurovascular injury.
- Open fractures
- Comminuted fractures
- Pathological fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual Intramedullary Nailing Fixation Versus Dual Plating of Pediatric Both Bone Forearm Fracture: a Study Protocol for a Randomized Controlled Trial
A randomized controlled trial to compare between dual intramedullary nailing and dual plating trying to synthesis a high quality evidence study that can solve the conflict between the decisions.
- Being tested
- Dual intramedullary nailing, Dual plating
- Keywords
- forearm fractures, pediatric fractures, flexible nail, plate fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual intramedullary nailingDevice
- Elastic nailing for radius under image guidance through distal entry point and physeal sparing technique.
Dual platingDevice
- ORIF for radius done first through volar approach.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Intramedullary nail group Receives: Device: Dual intramedullary nailing |
| group 2 | Experimental | Plating group Receives: Device: Dual plating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to union
weeks required to achieve union
Measured: 6 months
Elbow range of motion
elbow flexion, extension, pronation and supination in degrees
Measured: 6 months
Quick DASH score
Patient reported questionnaire
Measured: 6 months
patient satisfaction questionnaire
five points Likert scale
Measured: 6 months
Secondary outcomes (4)
Adverse events
Any adverse event will be recorded
Measured: 6 months
Re-operation rate
percentage of patients requiring reoperation
Measured: 6 months
size of wound scar in millimeters
measuring the size of wound scar in millimeters
Measured: 6 months
Deformity (malunion rate)
Malunion deformity
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 posted7 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intramedullary NailStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Mahran, MD, Study chair, Ain Shams UniversityAhmed Saeed Younis, Study director, Ain Shams UniversityAbdelrahman Hani, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542471
- Sponsor's protocol ID
- 23ew234
- Acronym
- DINDPL
- Status last verified
- Jun 2024
- First submitted
- 6 Jul 2024
- Last updated
- 7 Aug 2024
- 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 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Intramedullary Nailing Fixation Versus Dual Plating of Pediatric Both Bone Forearm Fracture: a Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06542471
- Acronym / sponsor ID
- DINDPL / 23ew234
- Keywords
- forearm fractures, pediatric fractures, flexible nail, plate fixation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 7 Aug 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.
A randomized controlled trial to compare between dual intramedullary nailing and dual plating trying to synthesis a high quality evidence study that can solve the conflict between the decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Device: Dual intramedullary nailingIntramedullary nail group |
| group 2 | Experimental | Device: Dual platingPlating group |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Both-bone Forearm Diaphyseal Fracture.
- age more than or equal nine years old with open distal radius physis.
- Simple transverse or short oblique fractures (2R2-A2,2R2-A3,2U2-A2,2U2-A3) according to OTA/ AO classification.
Key exclusion criteria (4 listed)
- Neurovascular injury.
- Open fractures
- Comminuted fractures
- Pathological fractures
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 |
|---|---|---|
| Dual intramedullary nailing- Elastic nailing for radius under image guidance through distal entry point and physeal sparing technique. | Device | group 1 |
| Dual plating- ORIF for radius done first through volar approach. | Device | group 2 |
Primary outcome
Time to union
Time frame: 6 months
weeks required to achieve union
Elbow range of motion
Time frame: 6 months
elbow flexion, extension, pronation and supination in degrees
Quick DASH score
Time frame: 6 months
Patient reported questionnaire
patient satisfaction questionnaire
Time frame: 6 months
five points Likert scale
4 secondary outcomes
Adverse events
Time frame: 6 months
Re-operation rate
Time frame: 6 months
size of wound scar in millimeters
Time frame: 6 months
Deformity (malunion rate)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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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.
Mahmoud Mahran, MD study chair
Ain Shams University
Ahmed Saeed Younis study director
Ain Shams University
Abdelrahman Hani principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual intramedullary nailing and Dual plating in people with Intramedullary Nail and Plate Fixation, run by Ain Shams 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 3 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 7 Aug 2024. 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?
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?
Time to union (time frame: 6 months). The study lists 4 primary outcomes in all. 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 7 Aug 2024.