NCT05625152

Brief Summary

Although several studies have studied the predictive nature of non-accidental trauma of the different types of fractures and in particular on the femur, the physiological and radiological particularities of the child make it difficult to estimate the age of a fracture and require defining a chronology specific to the specificities of the pediatric population. Some authors have carried out work for the dating of fractures, however the number of cases or the average age of the subjects does not allow a precise estimation of the chronology of evolution of the fractures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 15, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 2, 2023

Status Verified

November 1, 2022

Enrollment Period

2.1 years

First QC Date

November 14, 2022

Last Update Submit

October 30, 2023

Conditions

Keywords

Femur FractureFRACTURES IN CHILDRENPediatric populationBony Callus

Outcome Measures

Primary Outcomes (1)

  • Define retrospectively the chronology of the appearance of periosteal callus, secondary callus and remodeling phenomena from the study of radiographs of the femur

    Evaluation of the time to radiographic appearance of the following stages defined by the number of days elapsed between the date of diagnosis of the fracture and the first radiography taken during follow-up, making it possible to highlight one of these phenomena: * The radiographic periosteal reaction (or periosteal callus) defined by an opacity at the periphery of the fracture, corresponding to the first objectifiable calcification of the fracture hematoma and under the periosteum. * The secondary bone callus (or osteochondral) defined by a well-defined bone apposition of density close to that of the bone with opacification of the fracture line and union of the fracture site * Established remodeling activity when phenomena of axis correction, resorption of initial callus hypertrophy or re-permeabilizatio of the diaphyseal shaft can be demonstrated

    Files analysed retrospectively from January 01, 2007 to December 31, 2020 will be examined

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg University Hospitals between January 2007 and December 2020

You may qualify if:

  • Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg University Hospitals between January 2007 and December 2020
  • Fracture of the femur resulting from orthopedic treatment instituted during a period of hospitalization
  • Holders of parental authority who have been informed of the use of their child's data for the purposes of this research and who have not expressed any opposition

You may not qualify if:

  • Patient or legal representative who expressed their opposition to participating in the study
  • Fracture of the femur having benefited from a surgical intervention
  • Weakening metabolic or bone pathology
  • Fracture on pathological focal lesion
  • Fractures of the epiphysis or affecting the growth cartilage
  • Impossibility of giving informed information to the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Femoral FracturesCallosities

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 22, 2022

Study Start

September 15, 2020

Primary Completion

October 31, 2022

Study Completion

December 31, 2022

Last Updated

November 2, 2023

Record last verified: 2022-11

Locations