Fracture of Pediatric Neck FemurNCT05878496
Short Term Outcome of Pediatric Fracture of Neck Femur Fixation by Plate and Screws
A study testing fixation by plate and screws in people with Fracture of Pediatric Neck Femur, run by Sohag University at 1 site in Egypt.
Trial summary
the incidence of femoral neck fracture in children ranges between 0.3 and 0.5 of all childhood fractures per year. the incidence is maximum at the ranges of 11 and 12 years with a male preponderance ranging from 1.3 to 1.7:1. in contrast to osteoprotic proximal femur fractures in the eldery. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Fracture of Pediatric Neck Femur
- What is being tested?
- fixation by plate and screws
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Oct 2023
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children between 2 and 16 years having fracture of neck femur
Who cannot join
- patients more than 16 years, cases with open fractures, preexisting deformity, other pelvic or ipsilateral femoral injuries
Trial locations and contacts
1 site in 1 country.
abdelrahman h khalefa, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
magdy m amen, professor
About this study
the incidence of femoral neck fracture in children ranges between 0.3 and 0.5 of all childhood fractures per year. the incidence is maximum at the ranges of 11 and 12 years with a male preponderance ranging from 1.3 to 1.7:1. in contrast to osteoprotic proximal femur fractures in the eldery. although rarely seen in children fracture neck of femur has aconsiderable risk of complications such as avascular necrosisos femoral head, coxa vara, non union, delayed union, premature physeal arrest and infection. in infants and toddlrs below age of 2 years, closed reduction and fixation with smooth 1.8 or 2 mm K wires may be carried out, in children there are many methods of fixation, cannulated 4,4.5 screws, plates,dynamic hip screw.
Read the detailed description
the incidence of femoral neck fracture in children ranges between 0.3 and 0.5 of all childhood fractures per year. the incidence is maximum at the ranges of 11 and 12 years with a male preponderance ranging from 1.3 to 1.7:1. in contrast to osteoprotic proximal femur fractures in the eldery. although rarely seen in children fracture neck of femur has aconsiderable risk of complications such as avascular necrosisos femoral head, coxa vara, non union, delayed union, premature physeal arrest and infection. in infants and toddlrs below age of 2 years, closed reduction and fixation with smooth 1.8 or 2 mm K wires may be carried out, in children there are many methods of fixation, cannulated 4,4.5 screws, plates,dynamic hip screw.
- Conditions
- Fracture of Pediatric Neck Femur
- Being tested
- fixation by plate and screws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixation by plate and screwsProcedure or surgery
reduction and fixation of pediatric fracture neck femur by plate and screws
What is being measured
The primary outcome is the main question the study is designed to answer.
avascular necrosis by degree of bone necrosis in head and neck femur
osteonecrosis and death of bone tissue of head and neck femur
Measured: 6 months
Secondary outcomes (1)
coxa vara degree by angle of shaft and head femur
angle between the head and the shaft femur is reduced to less than 120 degrees
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 posted26 May 2023
- Study start1 Apr 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fracture of Pediatric Neck FemurStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Hussien Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878496
- Sponsor's protocol ID
- Soh-Med-23-04-22MS
- Status last verified
- May 2023
- First submitted
- 7 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patterson JT, Tangtiphaiboontana J, Pandya NK. Management of Pediatric Femoral Neck Fracture. J Am Acad Orthop Surg. 2018 Jun 15;26(12):411-419. doi: 10.5435/JAAOS-D-16-00362.
PubMed 29781820RATLIFF AH. Fractures of the neck of the femur in children. J Bone Joint Surg Br. 1962 Aug;44-B:528-42. doi: 10.1302/0301-620X.44B3.528. No abstract available.
PubMed 14038616Mirdad T. Fractures of the neck of femur in children: an experience at the Aseer Central Hospital, Abha, Saudi Arabia. Injury. 2002 Nov;33(9):823-7. doi: 10.1016/s0020-1383(02)00013-x.
PubMed 12379394Azouz EM, Karamitsos C, Reed MH, Baker L, Kozlowski K, Hoeffel JC. Types and complications of femoral neck fractures in children. Pediatr Radiol. 1993;23(6):415-20. doi: 10.1007/BF02012436.
PubMed 8255640
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcome of Pediatric Fracture of Neck Femur Fixation by Plate and Screws
- ClinicalTrials.gov ID
- NCT05878496
- Acronym / sponsor ID
- Soh-Med-23-04-22MS
- Conditions
- Fracture of Pediatric Neck Femur
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 26 May 2023 (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 incidence of femoral neck fracture in children ranges between 0.3 and 0.5 of all childhood fractures per year. the incidence is maximum at the ranges of 11 and 12 years with a male preponderance ranging from 1.3 to 1.7:1. in contrast to osteoprotic proximal femur fractures in the eldery. although rarely seen in children fracture neck of femur has aconsiderable risk of complications such as avascular necrosisos femoral head, coxa vara, non union, delayed union, premature physeal arrest and infection. in infants and toddlrs below age of 2 years, closed reduction and fixation with smooth 1.8 or 2 mm K wires may be carried out, in children there are many methods of fixation, cannulated 4,4.5 screws, plates,dynamic hip screw.
Detailed description
the incidence of femoral neck fracture in children ranges between 0.3 and 0.5 of all childhood fractures per year. the incidence is maximum at the ranges of 11 and 12 years with a male preponderance ranging from 1.3 to 1.7:1. in contrast to osteoprotic proximal femur fractures in the eldery. although rarely seen in children fracture neck of femur has aconsiderable risk of complications such as avascular necrosisos femoral head, coxa vara, non union, delayed union, premature physeal arrest and infection. in infants and toddlrs below age of 2 years, closed reduction and fixation with smooth 1.8 or 2 mm K wires may be carried out, in children there are many methods of fixation, cannulated 4,4.5 screws, plates,dynamic hip screw.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children between 2 and 16 years having fracture of neck femur
Key exclusion criteria (1 listed)
- patients more than 16 years, cases with open fractures, preexisting deformity, other pelvic or ipsilateral femoral injuries
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 |
|---|---|---|
| fixation by plate and screwsreduction and fixation of pediatric fracture neck femur by plate and screws | Procedure or surgery | – |
Primary outcome
avascular necrosis by degree of bone necrosis in head and neck femur
Time frame: 6 months
osteonecrosis and death of bone tissue of head and neck femur
1 secondary outcome
coxa vara degree by angle of shaft and head femur
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 26 May 2023.
- Background: PubMed 29781820Patterson JT, Tangtiphaiboontana J, Pandya NK. Management of Pediatric Femoral Neck Fracture. J Am Acad Orthop Surg. 2018 Jun 15;26(12):411-419. doi: 10.5435/JAAOS-D-16-00362.
- Background: PubMed 14038616RATLIFF AH. Fractures of the neck of the femur in children. J Bone Joint Surg Br. 1962 Aug;44-B:528-42. doi: 10.1302/0301-620X.44B3.528. No abstract available.
- Background: PubMed 12379394Mirdad T. Fractures of the neck of femur in children: an experience at the Aseer Central Hospital, Abha, Saudi Arabia. Injury. 2002 Nov;33(9):823-7. doi: 10.1016/s0020-1383(02)00013-x.
- Background: PubMed 8255640Azouz EM, Karamitsos C, Reed MH, Baker L, Kozlowski K, Hoeffel JC. Types and complications of femoral neck fractures in children. Pediatr Radiol. 1993;23(6):415-20. doi: 10.1007/BF02012436.
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.
abdelrahman h khalefa, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fixation by plate and screws in people with Fracture of Pediatric Neck Femur, 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 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: status not confirmed, as of the sponsor's last update on 26 May 2023. 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 mostafa h ahmed, resident (01155394994, mostafahusssin@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
avascular necrosis by degree of bone necrosis in head and neck femur (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05878496, which also lists 4 linked publications.
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 26 May 2023.