Clinical Trials Logo
  1. Home
  2. Femur Fracture
  3. NCT03775408
  4. Details
NCT03775408 Clinical Trial

FAST: Clinical Feasibility

Femur Fracture Clinical Trial

Official title:
Femoral Antegrade Starting Tool (FAST): Clinical Feasibility Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03775408
Other study ID # FAST2019
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 21, 2019
Est. completion date December 31, 2021

Study information
Verified date October 2021
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

The investigators will recruit 10 patients at Sunnybrook Health Sciences Centre that are scheduled to receive femoral antegrade intramedullary nailing to treat a femur fracture. This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST) device, and the surgical workflow during entry point selection and guidewire alignment for intramedullary nailing of femoral fractures. It is hypothesized that the usage of the tool will reduce surgery time and number of images required.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10
Est. completion date December 31, 2021
Est. primary completion date December 23, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with a femoral shaft fracture - Undergoing anterograde intramedullary nailing procedure Exclusion Criteria: - Femoral head or neck fractures

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Fluoroscopic Images Number of fluoroscopic images used to obtain start point 1 day
Secondary Number of guidewire drilling attempts Number of times the guidewire has been drilled into the bone to test the alignment. 1 day
See also
  Status Clinical Trial Phase
Completed NCT03231787 - Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery N/A
Completed NCT00888160 - Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care
Completed NCT05613257 - Distal Targeter vs Free-hand N/A
Withdrawn NCT00240396 - Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture N/A
Recruiting NCT01969279 - Radiographic Influences of Bisphosphonate Treatment on Femur N/A
Terminated NCT03160508 - Trochanter Fixation Nail Advanced (TFNA) Weight Bearing
Completed NCT04127045 - ProspEctive Cohort Study on Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population
Recruiting NCT03868280 - The FLiP Study, a Pilot Cluster Randomized Trial N/A
Completed NCT00725894 - Pediatric Locking Nail for the Treatment of Femoral Fractures in Children N/A
Recruiting NCT04657510 - Femoral frACturEs and COVID-19.
Completed NCT05225753 - Post-operative Anemia in Lateral Fractures of the Femur.
Completed NCT02793947 - Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures Phase 4
Completed NCT00916136 - Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures N/A
Completed NCT06430944 - Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children N/A
Completed NCT05183308 - Combined Drug Therapy in Lateral Fragility Fractures of the Femur
Not yet recruiting NCT00616044 - Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block N/A
Terminated NCT01484405 - Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture N/A
Completed NCT00943332 - Pediatric Femur Research Project
Not yet recruiting NCT00686023 - Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures N/A
Completed NCT01293916 - Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts N/A