Shaft Femure Fracture in AdolescentsNCT07067333
Fixation of Shaft Femure Fracrture by Ender Versus Plate
A study testing intramedullary nails for group A and plate for group B in people with Shaft Femure Fracture in Adolescents, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the functional outcomes, fracture healing time, rate of complications, and long-term growth outcomes between intramedullary nail and plating in adolescent. Assess radiographic outcomes (e.g., alignment, limb length discrepancy, and growth plate disturbance). Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Shaft Femure Fracture in Adolescents
- What is being tested?
- intramedullary nails for group A and plate for group B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Apr 2026
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 10-16 years (skeletally immature, based on radiographic evidence of growth plates).
- Diagnosis: Closed or open (Grade I) diaphyseal femoral fractures.
- Fracture type: Simple transverse, short oblique, or spiral fractures (classified by the AO/OTA system or by the Müller classification).
Who cannot join
- • Fractures with significant comminution or open fractures (Grade II or III).
- Pathological fractures (e.g., secondary to bone disease).
- Severe systemic conditions that may affect bone healing or postoperative recovery (e.g., metabolic bone diseases).
- Patients with previous ipsilateral femur fractures or those requiring re-operation for non-union or malunion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospital
Sohag
Magdy M Amin, Professor
Mohamed Hashem Ahmed, master
About this study
Official title: Elastic Intramedullary Nails Versus Plate Fixation in Treatment of Diaphyseal Femoral Fracture in Adolescent
The aim of this study is to compare the
- functional outcomes, fracture healing time, rate of complications, and long-term growth outcomes between intramedullary nail and plating in adolescent.
- Assess radiographic outcomes (e.g., alignment, limb length discrepancy, and growth plate disturbance).
- Evaluate complications such as infection, nonunion, malunion, refractures, and need for reoperation (e.g., hardware removal).
Read the detailed description
Elastic Nails (EN) are flexible intramedullary devices, usually made of titanium or stainless steel, that allow for dynamic stabilization. They are typically used for fractures in children and adolescents. The intramedullary nails offer the advantage of minimally invasive insertion, less disruption of the periosteum, and potential for less disruption of the growth plate.The nails bend and allow for some motion at the fracture site, which promotes healing through the formation of callus.
Plate fixation typically involves a compression or neutralization plate, usually a dynamic compression plate (DCP) or a locking plate. This method provides rigid stabilization but often requires more extensive dissection and can interfere with growth if the plate is applied too close to the physis (growth plate).While plating can be very effective in providing stability, there is a higher risk of complications such as hardware-related issues (e.g., plate prominence, need for removal) and potential growth disturbances.
- Conditions
- Shaft Femure Fracture in Adolescents
- Being tested
- intramedullary nails for group A, plate for group B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramedullary nails for group ADevice
fixation of the shaft femure fracture in this group by intramedullary nails
plate for group BDevice
fixation of the shaft femure fracture in the group b by plates
| Study group | Role | What they receive |
|---|---|---|
| group A for intramadullary nail | Active comparator | fixation of the femure in group A by intramedullary nails Receives: Device: intramedullary nails for group A |
| group B for plating | Active comparator | fixation of the shaft femure fracture in group B by plates Receives: Device: plate for group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture Femure fixation by intramedullary nails versus plates
limb length discrepancy by planning X rays.
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 posted16 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shaft Femure Fracture in AdolescentsStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hashem Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067333
- Sponsor's protocol ID
- Soh-Med--25-5-4MS
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastic Intramedullary Nails Versus Plate Fixation in Treatment of Diaphyseal Femoral Fracture in Adolescent
- ClinicalTrials.gov ID
- NCT07067333
- Acronym / sponsor ID
- Soh-Med--25-5-4MS
- Conditions
- Shaft Femure Fracture in Adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 16 Jul 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.
The aim of this study is to compare the
- functional outcomes, fracture healing time, rate of complications, and long-term growth outcomes between intramedullary nail and plating in adolescent.
- Assess radiographic outcomes (e.g., alignment, limb length discrepancy, and growth plate disturbance).
- Evaluate complications such as infection, nonunion, malunion, refractures, and need for reoperation (e.g., hardware removal).
Detailed description
Elastic Nails (EN) are flexible intramedullary devices, usually made of titanium or stainless steel, that allow for dynamic stabilization. They are typically used for fractures in children and adolescents. The intramedullary nails offer the advantage of minimally invasive insertion, less disruption of the periosteum, and potential for less disruption of the growth plate.The nails bend and allow for some motion at the fracture site, which promotes healing through the formation of callus.
Plate fixation typically involves a compression or neutralization plate, usually a dynamic compression plate (DCP) or a locking plate. This method provides rigid stabilization but often requires more extensive dissection and can interfere with growth if the plate is applied too close to the physis (growth plate).While plating can be very effective in providing stability, there is a higher risk of complications such as hardware-related issues (e.g., plate prominence, need for removal) and potential growth disturbances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A for intramadullary nail | Active comparator | Device: intramedullary nails for group Afixation of the femure in group A by intramedullary nails |
| group B for plating | Active comparator | Device: plate for group Bfixation of the shaft femure fracture in group B by plates |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 10-16 years (skeletally immature, based on radiographic evidence of growth plates).
- Diagnosis: Closed or open (Grade I) diaphyseal femoral fractures.
- Fracture type: Simple transverse, short oblique, or spiral fractures (classified by the AO/OTA system or by the Müller classification).
Key exclusion criteria (4 listed)
- • Fractures with significant comminution or open fractures (Grade II or III).
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 |
|---|---|---|
| intramedullary nails for group Afixation of the shaft femure fracture in this group by intramedullary nails | Device | group A for intramadullary nail |
| plate for group Bfixation of the shaft femure fracture in the group b by plates | Device | group B for plating |
Primary outcome
Fracture Femure fixation by intramedullary nails versus plates
Time frame: 6 months
limb length discrepancy by planning X rays.
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 16 Jul 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intramedullary nails for group A and plate for group B in people with Shaft Femure Fracture in Adolescents, 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 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: opening soon, as of the sponsor's last update on 16 Jul 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?
Contact Mohamed Hashem Ahmed, master (+2001097500949, mohammed.hashem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture Femure fixation by intramedullary nails versus plates (time frame: 6 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 16 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.