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OpenTrials
Completed

NCT Number: NCT03943329

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline, 1 Day

Secondary outcomes

  1. Change in mean length of time to distal screw placement

    Time frame: Baseline, 1 Day

  2. Change in total operative time

    Time frame: Baseline, 1 Day

  3. Change in total operative cost ($)

    Time frame: Baseline, 1 Day

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 9, 2019
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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