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NCT Number: NCT05613257

Distal Targeter vs Free-hand

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.

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Key information

Conditions

Femur Fracture Disease Femoral Fractures Fractures, Bone Fractures, Ununited Leg Injuries Nonunion of Fracture Nonunion of Fracture of Femur (Diagnosis) Nonunion of Fracture of Tibia Pathologic Processes Pathological Conditions, Signs and Symptoms Tibia Fracture Tibial Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Distal targeting jig

Device

Patients in this arm will have an assistive targeting device used for interlocking screw placement. The targeting device is attached to the nail proximally or distally (for antegrade or retrograde nailing, respectively) to guide screw placement through the other end of the intramedullary device.

Free-hand/perfect circles technique

Procedure

Patients in this arm will have no assistive targeting device use and the surgeon will use a free-hand technique for the placement of interlocking screws. With this technique, fluoroscopic images are taken such that the interlocking holes of the intramedullary device are "perfect circles" and indicate that a screw introduced in the same plane that the fluoroscopic image was taken would seat perpendicularly to the intramedullary device. This is the most commonly employed technique for interlocking screw placement through intramedullary devices.

Primary outcomes

  1. Patient Radiation Exposure

    Time frame: 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)

  2. Total Screw Placement Time

    Time frame: 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

  3. Measurement of Screw Placement Angle

    Time frame: Intraoperatively (at end of surgery)

    Correct screw placement is at a right (90-degree) angle from the intramedullary nail, through the interlocking screw hole

  4. Amount of Cumulative Radiation Exposure (in Grays)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • Stryker Nordic

Registry information

Official study title

A Randomized Controlled Trial Comparing Free-Hand Versus Distal Targeting Jig-Based for Distal Interlock Screw Placement

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2022
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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