Femoral Shaft Fractures, Hip Fractures
Conditions
Brief summary
This study will be a prospective, case - control trial looking at the use of a previously FDA approved device made by Stryker, a distal targeting system that eases the distal targeting of screws in cephalomedullary nails in hip and femoral shaft fractures. Patients who consent to participate in the study will either be in the control or device arm of the study depending on their surgeon.
Detailed description
Surgeries conducted by Dr. Konda or Dr. Leucht will be done using the device technique, surgeries completed by Dr. Egol or Dr. Tejwani will be done without the device, free hand technique. Each arm of the study will contain 29 patients. Patients who consent to participation will be enrolled in the study and placed in the correct arm based on who their surgeon is. Demographic and injury data will be collected. Intra-operatively, control patients will receive the SOC procedure. Device arm patients will have the distal targeting device used in their procedure, but the implant, will not be different than SOC.
Interventions
PROCEDUREDistal targeting device technique of distal screw placement
The second group will be the interventional group which will use the distal targeting device technique of distal screw placement and will be treated by Dr. Konda and Dr. Leucht. All relevant data to the study will be collected intra-operatively.
PROCEDUREStandard of Care
Will receive the standard of care free-hand technique of distal screw placement, as treated by Dr. Egol or Dr. Tejwani.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must be greater than or equal to 18 years of age. * The patient must have sustained a hip or femur fracture that is indicated for cephalomedullary nailing as the primary and definitive treatment measure. * The patient must be medically cleared for operative fixation of their fracture.
Exclusion criteria
* The patient does not meet all of the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean intra-operative radiation exposure to patients during their cephalomedullary nailing procedure. | Baseline, 1 Day |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean length of time to distal screw placement | Baseline, 1 Day |
| Change in total operative time | Baseline, 1 Day |
| Change in total operative cost ($) | Baseline, 1 Day |
Countries
United States
Outcome results
None listed