Trial of a Distal Targeting System for Cephalomedullary Nails as Part of Surgical Repair of Hip and Femoral Shaft Fractures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Trial of a Distal Targeting System for Cephalomedullary Nails as Part of Surgical Repair of Hip and Femoral Shaft Fractures

Conditions
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Hip Fractures, Femoral Shaft Fractures

Intervention / Treatment
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* Procedure: Standard of Care
* Procedure: Distal targeting device technique of distal screw placement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br> | Procedure: Standard of Care<br>* Will receive the standard of care free-hand technique of distal screw placement, as treated by Dr. Egol or Dr. Tejwani.<br>|
| Experimental: Distal Targeting Treatment<br> | Procedure: Distal targeting device technique of distal screw placement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean intra-operative radiation exposure to patients during their cephalomedullary nailing procedure. |  | Baseline, 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |