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

NCT03943329 | Completed

• 1 other identifier: 18-01951
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Femoral Shaft Fractures

Outcome Measures

Primary Outcomes (1)

• Change in mean intra-operative radiation exposure to patients during their cephalomedullary nailing procedure.

  Baseline, 1 Day

Secondary Outcomes (3)

• Change in mean length of time to distal screw placement

  Baseline, 1 Day

• Change in total operative time

  Baseline, 1 Day

• Change in total operative cost ($)

  Baseline, 1 Day

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Procedure: Standard of Care

Distal Targeting Treatment

EXPERIMENTAL

Procedure: Distal targeting device technique of distal screw placement

Interventions

Standard of Care PROCEDURE

Will receive the standard of care "free-hand" technique of distal screw placement, as treated by Dr. Egol or Dr. Tejwani.

Standard of Care

Distal targeting device technique of distal screw placement PROCEDURE

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.

Distal Targeting Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sanjit Konda, MD

  New York Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: December 17, 2019
• Primary Completion: December 7, 2020
• Study Completion: March 7, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

US (1)