- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05878496
Short Term Outcome of Pediatric Fracture of Neck Femur Fixation by Plate and Screws
May 18, 2023 updated by: Mostafa Hussien Ahmed, Sohag University
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: mostafa h ahmed, resident
- Phone Number: 01155394994
- Email: mostafahusssin@med.sohag.edu.eg
Study Contact Backup
- Name: abdelrahman h khalefa, professor
- Phone Number: 01003701283
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag university Hospital
-
Contact:
- magdy m amen, professor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- children between 2 and 16 years having fracture of neck femur
Exclusion Criteria:
- patients more than 16 years, cases with open fractures, preexisting deformity, other pelvic or ipsilateral femoral injuries
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
coxa vara degree by angle of shaft and head femur
Time Frame: 6 months
|
angle between the head and the shaft femur is reduced to less than 120 degrees
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- RATLIFF 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.
- Mirdad 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.
- Azouz 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Estimated)
October 1, 2023
Study Completion (Estimated)
October 1, 2023
Study Registration Dates
First Submitted
May 7, 2023
First Submitted That Met QC Criteria
May 18, 2023
First Posted (Actual)
May 26, 2023
Study Record Updates
Last Update Posted (Actual)
May 26, 2023
Last Update Submitted That Met QC Criteria
May 18, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-23-04-22MS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fracture of Pediatric Neck Femur
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Clinical Trials on fixation by plate and screws
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Sohag UniversityRecruiting
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Prisma Health-UpstateIndiana University; Orthopaedic Trauma AssociationCompletedHigh Energy Midshaft Clavicle FracturesUnited States
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Stanford UniversityTerminatedMedial Malleolus FracturesUnited States
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Danderyd HospitalCompletedRadius FracturesSweden
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Joseph Van SickelsCompleted
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Second Affiliated Hospital, School of Medicine,...The First People's Hospital of Huzhou; Taizhou Hospital; Ningbo No.2 HospitalNot yet recruiting
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University of WarwickDePuy International; University Hospitals Coventry and Warwickshire NHS TrustUnknown