NCT06591585

Brief Summary

Midterm radiographic and function follow up of pediatric pelvic fractures managed at Assiut University Hospital ( AUH) with a minimum of 3 years Analysis of all recorded cases of pediatric Pelvic Fracture in AUH trauma unit from 2015 until june 2024

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 8, 2024

Last Update Submit

September 8, 2024

Conditions

Keywords

pediatric pelvic fracture

Outcome Measures

Primary Outcomes (1)

  • Modified Majeed Functional scoring system

    base line

Interventions

A-Clinical evaluation 1. Patients will be recruited for evaluation of documented short / long term complications: * subcutaneous haematoma * pin tract infection * surgical site infection * limb length discrepancy * arthritis of the hip and spine * SI joint pain or fusion * scoliosis 2. Visually assisted gait analysis B- Radiographic evaluation 1-Radiographic evaluation of pelvic integrity by plain X-ray ( Antero-posterior . inlet . outlet views) 2- Long film for limb length discrepancy 3- plain x ray whole spine Anterior -posterior \& lateral for scoliosis

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

patients with age ≤17years with Open fracture\\ Closed fractures pelvis that was treated surgically or not

You may qualify if:

  • patient age ≤17years
  • Open fracture\\ Closed fractures
  • with or without neurovascular injury
  • polytrauma (including femur \& tibia fracture)
  • patients who were treated conservatively (bed rest + traction)
  • patients treated surgically

You may not qualify if:

  • patients aged \>17 years Isolated acetabulum Fractures Sample size calculation : Sample size was calculated using Epi- Info7. According to results of previous study \[4\] , Pelvic asymmetry occurs in 9.2% of patients undergoing open reduction internal fixation . Based on this percentage, confidence limits of 5% and a confidence level of 95%, the sample needed for the study was estimated to be about 63 patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sanz-Esteban I, Calvo-Lobo C, Rios-Lago M, Alvarez-Linera J, Munoz-Garcia D, Rodriguez-Sanz D. Mapping the human brain during a specific Vojta's tactile input: the ipsilateral putamen's role. Medicine (Baltimore). 2018 Mar;97(13):e0253. doi: 10.1097/MD.0000000000010253.

MeSH Terms

Interventions

Fracture Healing

Intervention Hierarchy (Ancestors)

Wound HealingRegenerationBiological Phenomena

Central Study Contacts

kirollos raafat Ramzy, Physician

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

September 8, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

September 1, 2025

Study Completion

November 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share