Short Term Outcome of Pediatric Fracture of Neck Femur Fi... | NCT05878496

Studies
Short Term Outcome of Pediatric Fracture of Neck Femur Fixation by Plate and Screws

NCT05878496

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

May 26, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Fracture of Pediatric Neck Femur

Interventions

fixation by plate and screws

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Oct 1, 2023Estimated

First Submitted Date

May 7, 2023

First Submission Date that Met QC Criteria

May 18, 2023

First Posted Date

May 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2023

Last Update Posted Date

May 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mostafa Hussien Ahmed, short term outcome of pediatric fracture of neck femur fixation by plate and screws, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fixation by plate and screws	Procedure	reduction and fixation of pediatric fracture neck femur by plate and screws

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
avascular necrosis by degree of bone necrosis in head and neck femur	osteonecrosis and death of bone tissue of head and neck femur	6 months

Secondary Outcomes

Measure	Description	Time Frame
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	6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mostafa h ahmed, resident	Contact	01155394994		mostafahusssin@med.sohag.edu.eg
abdelrahman h khalefa, professor	Contact	01003701283

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University Hospital	Recruiting	Sohag			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29781820	Background	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.
14038616	Background	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.

Type	Date	Date Unknown
Release	Feb 5, 2024
Reset	Jul 25, 2024