Fracture Neck of FemurNCT06267885
Fixation of Fracture Neck of Femur in Children
A study testing Cannulated screws vs wagner's technique in people with Fracture Neck of Femur, run by Assiut University at 1 site in Egypt.
Trial summary
Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Fracture Neck of Femur
- What is being tested?
- Cannulated screws vs wagner's technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2024to Mar 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical diagnosis of fracture neck of femur
- children with age less than 14 years old
Who cannot join
- pathological fracture
- patients with cerebral palsy
- Associated ipsilateral femoral shaft fracture
- comminuted fractures
- old fracture ( > 2 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fixation of Fracture Neck of Femur in Children by Cannulated Screws VS Wagner's Technique.
Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique
Read the detailed description
In the pediatric population, fracture of the neck of femur is relatively uncommon usually caused by high-energy trauma, but with high complication rates, despite appropriate diagnosis and management. The high rate of complication is due to the vascular anatomy of proximal femur.
Fracture neck of femur can be classified into transphyseal , transcervical (which is commonest), basal and pertrochanteric.
Complications include avascular necrosis, delayed union and non-union. Multiple fracture fixation methods have been used, with the overall goal being anatomic reduction with stable fixation.
Methods of fixation vary based on age, Delbet classification and dispalcement of the fracture.
Two types of fixation of pediatric fracture NOF of interest are cannulated screw (CS) and the Wagner technique.
Most studies agree that 3 screws are enough, and they should be inserted parallel in triangular arrangement with an inverted triangle. The CS should apply compression to the fracture (compression screws) to minimize the remaining fracture gap and accelerate the healing process. The use of washers allows for higher compression forces and thus increases the initial stabilization. CS shouldn't pass the physis in pediatrics to allow normal continuation of growth in children. The stability of fixation by CS has been shown to be affected by several factors: screw type, number, thickness, position and direction. Some of CS disadvantages are that they are mechanically unstable, failure of stabilization leads to varus malunion and it may lead to slipped capital femora epiphysis (SCFE) above the tips of the screws(especially short working distance in transcervical fractures).
The Wagner technique consists of the use of two or three k-wires bent as close as possible to the shaft and fixed to the shaft by two cerclage wires. Some advantages of this method are that k-wires can cross the physis and give good stability to the fracture with normal continuation of growth(especially in transphyseal \& transcerviacal fractures). Hip spica is recommended to give more stabilization to the fixation and neutralize forces around the fixed fracture.
- Conditions
- Fracture Neck of Femur
- Being tested
- Cannulated screws vs wagner's technique
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannulated screws vs wagner's techniqueProcedure or surgery
Fixation of fracture neck of femur by cannulated screws or wagner's technique
| Study group | Role | What they receive |
|---|---|---|
| Patients with fracture neck of femur fixed by cannulated screws | Active comparator | Fix the fracture by two to three cannulatef screws Receives: Procedure: Cannulated screws vs wagner's technique |
| Patient with fracture neck of femur fixed by wagner's technique | Active comparator | Fix the fracture by three to four k-wires Receives: Procedure: Cannulated screws vs wagner's technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The better method for fixation of fracture neck of femur
The rate of cases with complications with avascular necrosis in each method
Measured: Baseline, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture Neck of FemurStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maged, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267885
- Sponsor's protocol ID
- Children NOF fracture fixation
- Status last verified
- Feb 2024
- First submitted
- 13 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of Fracture Neck of Femur in Children by Cannulated Screws VS Wagner's Technique.
- ClinicalTrials.gov ID
- NCT06267885
- Acronym / sponsor ID
- Children NOF fracture fixation
- Conditions
- Fracture Neck of Femur
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 20 Feb 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.
Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique
Detailed description
In the pediatric population, fracture of the neck of femur is relatively uncommon usually caused by high-energy trauma, but with high complication rates, despite appropriate diagnosis and management. The high rate of complication is due to the vascular anatomy of proximal femur.
Fracture neck of femur can be classified into transphyseal , transcervical (which is commonest), basal and pertrochanteric.
Complications include avascular necrosis, delayed union and non-union. Multiple fracture fixation methods have been used, with the overall goal being anatomic reduction with stable fixation.
Methods of fixation vary based on age, Delbet classification and dispalcement of the fracture.
Two types of fixation of pediatric fracture NOF of interest are cannulated screw (CS) and the Wagner technique.
Most studies agree that 3 screws are enough, and they should be inserted parallel in triangular arrangement with an inverted triangle. The CS should apply compression to the fracture (compression screws) to minimize the remaining fracture gap and accelerate the healing process. The use of washers allows for higher compression forces and thus increases the initial stabilization. CS shouldn't pass the physis in pediatrics to allow normal continuation of growth in children. The stability of fixation by CS has been shown to be affected by several factors: screw type, number, thickness, position and direction. Some of CS disadvantages are that they are mechanically unstable, failure of stabilization leads to varus malunion and it may lead to slipped capital femora epiphysis (SCFE) above the tips of the screws(especially short working distance in transcervical fractures).
The Wagner technique consists of the use of two or three k-wires bent as close as possible to the shaft and fixed to the shaft by two cerclage wires. Some advantages of this method are that k-wires can cross the physis and give good stability to the fracture with normal continuation of growth(especially in transphyseal \& transcerviacal fractures). Hip spica is recommended to give more stabilization to the fixation and neutralize forces around the fixed fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with fracture neck of femur fixed by cannulated screws | Active comparator | Procedure: Cannulated screws vs wagner's techniqueFix the fracture by two to three cannulatef screws |
| Patient with fracture neck of femur fixed by wagner's technique | Active comparator | Procedure: Cannulated screws vs wagner's techniqueFix the fracture by three to four k-wires |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- clinical diagnosis of fracture neck of femur
- children with age less than 14 years old
Key exclusion criteria (5 listed)
- pathological fracture
- patients with cerebral palsy
- Associated ipsilateral femoral shaft fracture
- comminuted fractures
- old fracture ( > 2 weeks)
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 |
|---|---|---|
| Cannulated screws vs wagner's techniqueFixation of fracture neck of femur by cannulated screws or wagner's technique | Procedure or surgery | Patient with fracture neck of femur fixed by wagner's technique, Patients with fracture neck of femur fixed by cannulated screws |
Primary outcome
The better method for fixation of fracture neck of femur
Time frame: Baseline, one year
The rate of cases with complications with avascular necrosis in each method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannulated screws vs wagner's technique in people with Fracture Neck of Femur, run by Assiut 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 2 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: status not confirmed, as of the sponsor's last update on 20 Feb 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?
Contact Mina Maged, Resident (01205188908, Menamaged54@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The better method for fixation of fracture neck of femur (time frame: Baseline, one year). 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 20 Feb 2024.