Trial Outcomes & Findings for TRIGEN SURESHOT™ Distal Targeting System Study (NCT NCT01327508)

NCT ID: NCT01327508

Last Updated: 2018-03-14

Results Overview

Radiation exposure measured in two ways: Whole body badge TLD ring badge

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Intraoperative
• Results posted on: 2018-03-14

Participant Flow

Participant milestones

Measure	TRIGEN SURESHOT Distal Targeting TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes. TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system	Standard Nailing Instrumentation. Free-hand technique utilizes x-rays to find screw holes Free-hand technique: Free-hand technique utilizes x-rays to find screw holes.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TRIGEN SURESHOT™ Distal Targeting System Study

Baseline characteristics by cohort

Measure	TRIGEN SURESHOT Distal Targeting n=30 Participants TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes. TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system	Standard Nailing Instrumentation. n=30 Participants Free-hand technique utilizes x-rays to find screw holes Free-hand technique: Free-hand technique utilizes x-rays to find screw holes.	Total n=60 Participants Total of all reporting groups
Age, Continuous	37.7 Years STANDARD_DEVIATION 19.0 • n=5 Participants	35.3 Years STANDARD_DEVIATION 19.5 • n=7 Participants	36.5 Years STANDARD_DEVIATION 19.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative

Population: Primary endpoint voided. Dosimeters did not capture radiation dose as expected.

Radiation exposure measured in two ways:

Whole body badge TLD ring badge

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intraoperative

Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws.

Outcome measures

Measure	TRIGEN SURESHOT Distal Targeting n=30 Participants TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes. TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system	Standard Nailing Instrumentation. n=30 Participants Free-hand technique utilizes x-rays to find screw holes Free-hand technique: Free-hand technique utilizes x-rays to find screw holes.
Distal Locking Time	12.6 minutes Standard Deviation 6.9	14.7 minutes Standard Deviation 8.4

Adverse Events

TRIGEN SURESHOT Distal Targeting

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Standard Nailing Instrumentation.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TRIGEN SURESHOT Distal Targeting n=30 participants at risk TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes. TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system	Standard Nailing Instrumentation. n=30 participants at risk Free-hand technique utilizes x-rays to find screw holes Free-hand technique: Free-hand technique utilizes x-rays to find screw holes.
Surgical and medical procedures Change out screw	6.7% 2/30 • Number of events 2 • Operative and immediate postoperative	0.00% 0/30 • Operative and immediate postoperative
Surgical and medical procedures Probe misplacement	6.7% 2/30 • Number of events 2 • Operative and immediate postoperative	0.00% 0/30 • Operative and immediate postoperative

Additional Information

Cathy Newbill

Smith & Nephew, Inc.

Phone: 800-821-5700

Email: cathy.newbill@smith-nephew.com

Results disclosure agreements

• Principal investigator is a sponsor employee * Sponsor shall have the sole right for 12 mo after completion of Study at all sites to arrange for the submission of the multi-center article or presentation * After the 12 mo, upon Sponsor approval or after the multicenter publication occurs, Investigator may publish, present and use for instruction and research, Investigator's results arising out of its conduct of the Study at the Site. Investigator may not disclose Sponsor Confidential Information, and Sponsor protects its proprietary rights
• Publication restrictions are in place

Restriction type: OTHER