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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943329
• Other study ID #: 18-01951
• Status: Completed
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: March 7, 2021

Study information

• Verified date: February 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 7, 2021
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Femoral Shaft Fractures
• Fractures, Bone
• Hip Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean intra-operative radiation exposure to patients during their cephalomedullary nailing procedure.		Baseline, 1 Day
Secondary	Change in mean length of time to distal screw placement		Baseline, 1 Day
Secondary	Change in total operative time		Baseline, 1 Day
Secondary	Change in total operative cost ($)		Baseline, 1 Day