Femur Fracture, Nonunion of Fracture, Nonunion of Fracture of Femur (Diagnosis), Nonunion of Fracture of Tibia, Tibia Fracture, Tibial Fractures
Conditions
Keywords
femur fracture, tibia fracture, operative time, screw placement, 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.
Interventions
DEVICEDistal targeting jig
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.
PROCEDUREFree-hand/perfect circles technique
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.
Sponsors
Stryker Nordic
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Patients will be randomly assigned to cohorts based on the operative technique used to treat their respective fractures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Free-hand/Perfect Circles Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.
Free-hand/perfect circles technique: 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. | 33 |
| Distal Targeting Jig Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig
Distal targeting jig: 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. | 29 |
| Total | 62 |
Baseline characteristics
| Characteristic | Distal Targeting Jig | Total | Free-hand/Perfect Circles |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 22 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 40 Participants | 22 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 22.81 | 53 years STANDARD_DEVIATION 22.9 | 53 years STANDARD_DEVIATION 23.32 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 29 participants | 62 participants | 33 participants |
| Sex: Female, Male Female | 17 Participants | 35 Participants | 18 Participants |
| Sex: Female, Male Male | 12 Participants | 27 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 29 |
| other Total, other adverse events | 0 / 33 | 0 / 29 |
| serious Total, serious adverse events | 0 / 33 | 0 / 29 |
Outcome results
Primary
Amount of Cumulative Radiation Exposure (in Grays)
Total radiation exposure during distal screw placement
Time frame: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Free-hand/Perfect Circles | Amount of Cumulative Radiation Exposure (in Grays) | 1.14 grays | Standard Deviation 1.19 |
| Distal Targeting Jig | Amount of Cumulative Radiation Exposure (in Grays) | 1.51 grays | Standard Deviation 3.64 |
Primary
Measurement of Screw Placement Angle
Correct screw placement is at a right (90-degree) angle from the intramedullary nail, through the interlocking screw hole
Time frame: Intraoperatively (at end of surgery)
Population: Zero participants were analyzed as this data metric was not collected at the end of surgery in any of the participants as there was no reliable way to obtain this measurement.
Primary
Patient Radiation Exposure
Number of fluoroscopic images taken intraoperatively for screw placement and 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Free-hand/Perfect Circles | Patient Radiation Exposure | 47.03 images taken | Standard Deviation 23.56 |
| Distal Targeting Jig | Patient Radiation Exposure | 10.24 images taken | Standard Deviation 10.63 |
Primary
Total Screw Placement Time
time taken to place interlocking screws
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Free-hand/Perfect Circles | Total Screw Placement Time | 14.87 minutes | Standard Deviation 8.86 |
| Distal Targeting Jig | Total Screw Placement Time | 15.44 minutes | Standard Deviation 14.33 |