Back to resultsShort Term Outcome of Pediatric Fracture of Neck Femur Fixation by Plate and Screws
Primary Purpose
Fracture of Pediatric Neck Femur
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fixation by plate and screws
Sponsored by
About this trial
This is an interventional treatment trial for Fracture of Pediatric Neck Femur
Eligibility Criteria
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
Sites / Locations
- Sohag University HospitalRecruiting
Outcomes
Primary Outcome Measures
avascular necrosis by degree of bone necrosis in head and neck femur
osteonecrosis and death of bone tissue of head and neck femur
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05878496
Brief Title
Short Term Outcome of Pediatric Fracture of Neck Femur Fixation by Plate and Screws
Official Title
Short Term Outcome of Pediatric Fracture of Neck Femur Fixation by Plate and Screws
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Pediatric Neck Femur
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
fixation by plate and screws
Intervention Description
reduction and fixation of pediatric fracture neck femur by plate and screws
Primary Outcome Measure Information:
Title
avascular necrosis by degree of bone necrosis in head and neck femur
Description
osteonecrosis and death of bone tissue of head and neck femur
Time Frame
6 months
Secondary Outcome Measure Information:
Title
coxa vara degree by angle of shaft and head femur
Description
angle between the head and the shaft femur is reduced to less than 120 degrees
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mostafa h ahmed, resident
Phone
01155394994
Email
mostafahusssin@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
abdelrahman h khalefa, professor
Phone
01003701283
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
magdy m amen, professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
29781820
Citation
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.
Results Reference
background
PubMed Identifier
14038616
Citation
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.
Results Reference
background
PubMed Identifier
12379394
Citation
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.
Results Reference
background
PubMed Identifier
8255640
Citation
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.
Results Reference
background
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Short Term Outcome of Pediatric Fracture of Neck Femur Fixation by Plate and Screws
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