Distal Targeter vs Free-hand

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Distal targeting jig
* Procedure: Free-hand/perfect circles technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomly assigned to cohorts based on the operative technique used to treat their respective fractures.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Free-hand/perfect circles<br>Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique. | Procedure: Free-hand/perfect circles technique<br>* 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.<br>|
| Experimental: Distal targeting jig<br>Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig | Device: Distal targeting jig<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Radiation exposure | Number of fluoroscopic images taken intraoperatively for screw placement and 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 screw placement time | time taken to place interlocking screws | 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) | 
| Measurement of Screw Placement Angle | Correct screw placement is at a right (90-degree) angle from the intramedullary nail, through the interlocking screw hole | Intraoperatively (at end of surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Learning curve | learning curve between distal targeter and freehand techniques stratified by level of training | Through study completion (6 month study period) | 
| Training methods | Correlation of sawbones-based practice and clinical practice for interlocking screw placement with regards to time taken for screw placement and accuracy of screw placement (deviation from right angle relative to intramedullary device) | Through study completion (6 month study period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femur fracture, tibia fracture, operative time, screw placement, jig