Distal Targeter vs Free-hand

Not Applicable

Completed

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

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

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Free-hand/perfect circles	Free-hand/perfect circles technique	Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.
Distal targeting jig	Distal targeting jig	Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig

Primary Outcome Measures

Name	Time	Method
Patient Radiation Exposure	During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement	Number of fluoroscopic images taken intraoperatively for screw placement and cumulative radiation exposure (in grays)
Total Screw Placement Time	During surgery: the first fluoroscopy shot to localize the jig or obtain a perfect circle (start) to the last shot to confirm complete seating of the screw (end time)	time taken to place interlocking screws
Measurement of Screw Placement Angle	Intraoperatively (at end of surgery)	Correct screw placement is at a right (90-degree) angle from the intramedullary nail, through the interlocking screw hole
Amount of Cumulative Radiation Exposure (in Grays)	During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement	Total radiation exposure during distal screw placement