NCT03775408

Brief Summary

This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

May 21, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

December 12, 2018

Last Update Submit

October 20, 2021

Conditions

Femur Fracture

Outcome Measures

Primary Outcomes (1)

  • Procedure Time

    Time of the procedure from the initiation of the guidewire step (surgeon picking up the guidewire) to the removal of the FAST device following acceptable guidewire placement

    1 day

Secondary Outcomes (2)

  • Fluoroscopic Images

    1 day

  • Number of guidewire drilling attempts

    1 day

Study Arms (1)

FAST Patients

Patients at Sunnybrook Health Sciences Centre with femur fractures that will undergo a femoral antegrade intramedullary nailing procedure.

Device: FAST

Interventions

FASTDEVICE

Orthopaedic surgeons will use the FAST device to facilitate entry point selection and alignment of a guidewire for intramedullary nailing of femoral shaft fractures.

FAST Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized at Sunnybrook Health Sciences Centre

You may qualify if:

  • Patients with a femoral shaft fracture
  • Undergoing anterograde intramedullary nailing procedure

You may not qualify if:

  • Femoral head or neck fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • Ebrahimi H, Yee A, Whyne C. Surgical process analysis identifies lack of connectivity between sequential fluoroscopic 2D alignment as a critical impediment in femoral intramedullary nailing. Int J Comput Assist Radiol Surg. 2016 Feb;11(2):297-305. doi: 10.1007/s11548-015-1262-6. Epub 2015 Jul 21.

    PMID: 26194487BACKGROUND

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Sebastian Tomescu, MD MSc FRCS

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 13, 2018

Study Start

May 21, 2019

Primary Completion

December 23, 2019

Study Completion

December 31, 2021

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)