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RecruitingNCT05878496Updated May 26, 2023

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

An interventional study of fixation by plate and screws in Fracture of Pediatric Neck Femur, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2023-05-26.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
1 Year to 16 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Fracture of Pediatric Neck Femur
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 20 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • children between 2 and 16 years having fracture of neck femur

Exclusion criteria

Exclusion Criteria:

  • patients more than 16 years, cases with open fractures, preexisting deformity, other pelvic or ipsilateral femoral injuries
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • Procedurefixation by plate and screws

    reduction and fixation of pediatric fracture neck femur by plate and screws

06

What researchers measure

Primary outcomes

  1. avascular necrosis by degree of bone necrosis in head and neck femur

    osteonecrosis and death of bone tissue of head and neck femur

    Time frame: 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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Sohag University Hospital
    Sohag, Egypt
    • magdy m amen, professor · Contact
    Recruiting
08

References and documents

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 29781820 ↗
  • 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. PubMed 14038616 ↗
  • 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. PubMed 12379394 ↗
  • 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. PubMed 8255640 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05878496
Lead sponsor
Sohag University
Responsible party
Mostafa Hussien Ahmed (short term outcome of pediatric fracture of neck femur fixation by plate and screws, Sohag University) — Principal investigator
First posted
May 26, 2023
Start date
Apr 1, 2023
Primary completion
Oct 1, 2023 (estimated)
Completion
Oct 1, 2023 (estimated)
Last update
May 26, 2023

Study contacts

mostafa h ahmed, resident
Contact
mostafahusssin@med.sohag.edu.eg
01155394994
abdelrahman h khalefa, professor
Contact
01003701283

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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