FAST: Clinical Feasibility
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03775408|
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment|
|Femur Fracture||Device: FAST|
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Femoral Antegrade Starting Tool (FAST): Clinical Feasibility Pilot Study|
|Actual Study Start Date :||May 21, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Patients at Sunnybrook Health Sciences Centre with femur fractures that will undergo a femoral antegrade intramedullary nailing procedure.
Orthopaedic surgeons will use the FAST device to facilitate entry point selection and alignment of a guidewire for intramedullary nailing of femoral shaft fractures.
- Procedure Time [ Time Frame: 1 day ]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
- Fluoroscopic Images [ Time Frame: 1 day ]Number of fluoroscopic images used to obtain start point
- Number of guidewire drilling attempts [ Time Frame: 1 day ]Number of times the guidewire has been drilled into the bone to test the alignment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775408
|Contact: Sebastian Tomescu, MD MSc FRCSfirstname.lastname@example.org|
|Contact: Richard Jenkinson, MD MSc FRCSemail@example.com|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Sebastian Tomescu, MD MSc FRCS 416-928-3279 firstname.lastname@example.org|
|Contact: Richard Jenkinson, MD MSc FRCS 416-480-6160 email@example.com|
|Principal Investigator:||Sebastian Tomescu, MD MSc FRCS||Sunnybrook Health Sciences Centre|