- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03943329
Recruitment Status Active, not recruiting
First Posted May 9, 2019
Last update posted March 30, 2021
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.
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.
|Active Comparator: Standard of Care
Procedure: Standard of Care
Will receive the standard of care "free-hand" technique of distal screw placement, as treated by Dr. Egol or Dr. Tejwani.
|Experimental: Distal Targeting Treatment
Procedure: Distal 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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.
- The patient does not meet all of the inclusion criteria.
United States, New York
New York University School of Medicine
NYU Langone Health
Principal Investigator: Sanjit Konda, MD New York Langone Medical Center