Trials Sponsors Conditions Drugs Pricing

Conditions

Femoral Shaft Fracture

Keywords

Pediatric femur fractureSpica castingTractionIntramedullary nailingChildrenInternal fixationExternal fixation

Outcome Measures

Primary Outcomes (1)

Fracture alignment
Mechanical and anatomical axes
up to 24 months

Secondary Outcomes (7)

Range of Motion (ROM)
up to 24 months
Axial deviation
up to 24 months
Leg Length Discrepancy
up to 24 months
Quadriceps strength
up to 24 months
Return to full activity
up to 24 months
+2 more secondary outcomes

Study Arms (1)

Femoral shaft fracture

Patients (children up to 16 years old) diagnosis of isolated closed femur shaft fracture (3.2-D) and open distal physis. Treatment strategies will follow standard of care (routine) procedures, either conservative (non-surgical) treatment or surgical treatment.

Procedure: Conservative (non-surgical) treatmentProcedure: Surgical treatment

Interventions

Conservative (non-surgical) treatmentProcedure

Spica cast Traction Traction and spica cast

Femoral shaft fracture

Surgical treatmentProcedure

Elastic Stable Intramedullary Nailing (ESIN) Conventional locking intramedullary nail Plating External fixation

Femoral shaft fracture

Eligibility Criteria

AgeUp to 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodProbability Sample

Study Population

Consecutive patients (children up to 16 years old) presenting with an isolated closed femur shaft fracture (3.2-D) and open distal physis.

You may qualify if:

Age less than 16 years of age at the time of the injury

Sponsors & Collaborators

AO Innovation Translation Center
Otherlead

Study Sites (14)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Medical University Hospital of Graz

Graz, 8036, Austria

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

IWK Health Centre

Halifax, New Scotland, B3K-6R8, Canada

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Ontario, K1H 8L1, Canada

The Hospital for Sick Children

Toronto, Ontario, M5P3E1, Canada

Universitätsklinik Dresden

Dresden, 1307, Germany

MeSH Terms

Interventions

TherapeuticsSurgical Procedures, Operative

Study Officials

Peter P. Schmittenbecher, Prof.
Kinderchirurgische Klinik, Klinikum Karlsruhe
PRINCIPAL INVESTIGATOR
Unni G. Narayanan, Prof.
The Hospital for Sick Children, Toronto
PRINCIPAL INVESTIGATOR

Enrollment

322 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 24 Months
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 7, 2017

Study Start

March 14, 2018

Actual (reported)

Pediatric Femur Fracture Registry

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Femoral shaft fracture

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Femoral shaft fracture

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations