Trial of a Distal Targeting System for Cephalomedullary Nails as Part of Surgical Repair of Hip and Femoral Shaft Fractures
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Femoral Shaft Fractures
- Hip Fractures
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03943329
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sanjit Konda, MD New York Langone Medical Center
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