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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03943329

Recruitment Status Active, not recruiting

First Posted May 9, 2019

Last update posted March 30, 2021

Study Description

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.

  • Condition or Disease:Femoral Shaft Fractures
    Hip Fractures
  • Intervention/Treatment: Procedure: Standard of Care
    Procedure: Distal targeting device technique of distal screw placement
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 58 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: Trial of a Distal Targeting System for Cephalomedullary Nails as Part of Surgical Repair of Hip and Femoral Shaft Fractures
  • Actual Study Start Date: December 2019
  • Estimated Primary Completion Date: December 2020
  • Actual Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
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.
Outcome Measures
  • Primary Outcome Measures: 1. Percent (%) change in mean intra-operative radiation exposure to patients during their cephalomedullary nailing procedure. [ Time Frame: 1 Day ]
  • Secondary Outcome Measures: 1. Percent (%) change in mean length of time to distal screw placement [ Time Frame: 1 Day ]
  • 2. Percent (%) change in total operative time [ Time Frame: 1 Day ]
  • 3. Change in total operative time [ Time Frame: 1 Day ]
  • 4. Change in total operative cost ($) [ Time Frame: 1 Day ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts
Locations

United States, New York
New York University School of Medicine
New York

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Sanjit Konda, MD New York Langone Medical Center

More Information
  • Responsible Party: NYU Langone Health
  • ClinicalTrials.gov Identifier: NCT03943329 History of Changes
  • Other Study ID Numbers: 18-01951
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: March 30, 2021
  • Last Verified: March 2021
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Hip Fractures
    Femoral Fractures
    Fractures, Bone