Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-29 @ 10:02 AM
Study NCT ID:
NCT05613257
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2022-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Distal Targeter vs Free-hand
Sponsor:
Cedars-Sinai Medical Center
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Free-Hand Versus Distal Targeting Jig-Based for Distal Interlock Screw Placement
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: