Trial Outcomes & Findings for Distal Targeter vs Free-hand (NCT NCT05613257)

NCT ID: NCT05613257

Last Updated: 2025-04-10

Results Overview

Number of fluoroscopic images taken intraoperatively for screw placement and cumulative radiation exposure (in grays)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 89 participants
• Primary outcome timeframe: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
• Results posted on: 2025-04-10

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	52	37
Overall Study COMPLETED	33	29
Overall Study NOT COMPLETED	19	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Free-hand/Perfect Circles n=33 Participants 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.	Distal Targeting Jig n=29 Participants 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.	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=33 Participants	0 Participants n=29 Participants	0 Participants n=62 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=33 Participants	18 Participants n=29 Participants	40 Participants n=62 Participants
Age, Categorical >=65 years	11 Participants n=33 Participants	11 Participants n=29 Participants	22 Participants n=62 Participants
Age, Continuous	53 years STANDARD_DEVIATION 23.32 • n=33 Participants	43 years STANDARD_DEVIATION 22.81 • n=29 Participants	53 years STANDARD_DEVIATION 22.90 • n=62 Participants
Sex: Female, Male Female	18 Participants n=33 Participants	17 Participants n=29 Participants	35 Participants n=62 Participants
Sex: Female, Male Male	15 Participants n=33 Participants	12 Participants n=29 Participants	27 Participants n=62 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	33 participants n=33 Participants	29 participants n=29 Participants	62 participants n=62 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Free-hand/Perfect Circles n=33 Participants 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.	Distal Targeting Jig n=29 Participants 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.
Patient Radiation Exposure	47.03 images taken Standard Deviation 23.56	10.24 images taken Standard Deviation 10.63

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Free-hand/Perfect Circles n=32 Participants 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.	Distal Targeting Jig n=29 Participants 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.
Total Screw Placement Time	14.87 minutes Standard Deviation 8.86	15.44 minutes Standard Deviation 14.33

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Free-hand/Perfect Circles n=30 Participants 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.	Distal Targeting Jig n=28 Participants 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.
Amount of Cumulative Radiation Exposure (in Grays)	1.14 grays Standard Deviation 1.19	1.51 grays Standard Deviation 3.64

Adverse Events

Free-hand/Perfect Circles

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Distal Targeting Jig

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joel Arnold

Cedars Sinai Medical Center

Phone: 310-423-9839

Email: joel.arnold@cshs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place