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A Randomized Controlled Trial Comparing Free-Hand Versus Distal Targeting Jig-Based for Distal Interlock Screw Placement
This study is a randomized controlled trial comparing the use of two different surgical techniques--free-hand versus distal targeting jig-based for distal interlock screw--placement and their effects on total operative time and intraoperative radiation exposure.
Interlocking screw placement in intramedullary nailing of femoral and tibial shaft fractures improves rotational and length stability. However, free-hand perfect circle techniques can be technically challenging and may take up to an hour with increased radiation exposure to the surgeon and patient. Newer technologies aimed at reducing fluoroscope use such as electromagnetically-based aiming devices may increase the operative time. Proximally-based jigs have been shown to reduce fluoroscopy time in cadavers, however, have not been studied clinically. This study is a prospective, randomized controlled trial comparing a modern proximally-based distal targeting device and free-hand techniques for placement of interlocking screws in lower extremity nailing.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Cedars Sinai Medical Center
Los Angeles, California, United States
Start Date
October 31, 2022
Primary Completion Date
February 1, 2024
Completion Date
February 1, 2024
Last Updated
April 10, 2025
89
ACTUAL participants
Distal targeting jig
DEVICE
Free-hand/perfect circles technique
PROCEDURE
Lead Sponsor
Cedars-Sinai Medical Center
Collaborators
NCT07280169
NCT05699174
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05805774