Back to resultsTrial of a Distal Targeting System for Cephalomedullary Nails as Part of Surgical Repair of Hip and Femoral Shaft Fractures
Primary Purpose
Hip Fractures, Femoral Shaft Fractures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
Distal targeting device technique of distal screw placement
Sponsored by
About this trial
This is an interventional other trial for Hip Fractures
Eligibility 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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care
Distal Targeting Treatment
Arm Description
Outcomes
Primary Outcome Measures
Change in mean intra-operative radiation exposure to patients during their cephalomedullary nailing procedure.
Secondary Outcome Measures
Change in mean length of time to distal screw placement
Change in total operative time
Change in total operative cost ($)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03943329
Brief Title
Trial of a Distal Targeting System for Cephalomedullary Nails as Part of Surgical Repair of Hip and Femoral Shaft Fractures
Official Title
Trial of a Distal Targeting System for Cephalomedullary Nails as Part of Surgical Repair of Hip and Femoral Shaft Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
March 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Femoral Shaft Fractures
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Title
Distal Targeting Treatment
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
Will receive the standard of care "free-hand" technique of distal screw placement, as treated by Dr. Egol or Dr. Tejwani.
Intervention Type
Procedure
Intervention Name(s)
Distal targeting device technique of distal screw placement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean intra-operative radiation exposure to patients during their cephalomedullary nailing procedure.
Time Frame
Baseline, 1 Day
Secondary Outcome Measure Information:
Title
Change in mean length of time to distal screw placement
Time Frame
Baseline, 1 Day
Title
Change in total operative time
Time Frame
Baseline, 1 Day
Title
Change in total operative cost ($)
Time Frame
Baseline, 1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjit Konda, MD
Organizational Affiliation
New York Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of a Distal Targeting System for Cephalomedullary Nails as Part of Surgical Repair of Hip and Femoral Shaft Fractures
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