Distal Targeter vs Free-hand

Cedars-Sinai Medical Center

Status: Completed

Conditions: Nonunion of Fracture of Tibia; Tibia Fracture; Tibial Fractures; Femur Fracture; Nonunion of Fracture; Nonunion of Fracture of Femur (Diagnosis)

Treatments: Procedure: Free-hand/perfect circles technique; Device: Distal targeting jig

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05613257

STUDY00001778

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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89 participants in 2 patient groups

Free-hand/perfect circles

Active Comparator group

Description:

Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.

Treatment:

Procedure: Free-hand/perfect circles technique

Distal targeting jig

Experimental group

Description:

Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig

Treatment:

Device: Distal targeting jig