N/A N=89 Randomized Single-blind Treatment

Distal Targeter vs Free-hand

Femur Fracture · Tibial Fractures · Nonunion of Fracture · Nonunion of Fracture of Tibia · Nonunion of Fracture of Femur (Diagnosis)

Bottom Line

View on ClinicalTrials.gov: NCT05613257 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Patient Radiation Exposure — 47.03; 10.24 images taken

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Distal targeting jig (Device); Free-hand/perfect circles technique (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cedars-Sinai Medical Center
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Radiation Exposure	47.03; 10.24	—
PRIMARY Total Screw Placement Time	14.87; 15.44	—
PRIMARY Measurement of Screw Placement Angle	—	—
PRIMARY Amount of Cumulative Radiation Exposure (in Grays)	1.14; 1.51	—

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.

Eligibility Criteria

Inclusion Criteria

18 years old and above
Undergoing intramedullary fixation of femur or tibia shaft for acute fracture or nonunion

Exclusion Criteria

Prior ipsilateral tibial or femoral nail
Patients who cannot have interlocking screws placed
Pregnant women

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Data sourced from ClinicalTrials.gov (NCT05613257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.