A Randomized Controlled Trial Comparing Free-Hand Versus Distal Targeting Jig-Based for Distal Interlock Screw Placement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 89
- Locations
- 2
- Primary Endpoint
- Patient Radiation Exposure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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)
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
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Carol A. Lin, MD
Assistant Professor
Cedars-Sinai Medical Center