Safety and Efficacy of Distal Targeting System with Open Reduction Internal Fixation: Multicenter Randomized Controlled Trial Study

Safety and Efficacy of Distal Targeting System with Open Reduction Internal Fixation: Multicenter Randomized Controlled Trial Study - Safety and Efficacy of Distal Targeting System with ORIF: Multicenter RCT Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007298

Enrollment

196

Registered

2012-02-20

Start date

2011-12-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures of tibia bone

Interventions

Distal Targeting System TRIGEN SURESHOT Conventional distal locking technique using C-arm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient whose written consent was obtained to participate in the study 2. Patient with indication for Intramedullary Nail

Exclusion criteria

Exclusion criteria: 1. Patient with q pacemaker 2. Patient with metal implantation at tibia bone 3. Patient ruled unfit by surgeon

Design outcomes

Primary

Measure	Time frame
Presence or absence of adverse event	—

Secondary

Measure	Time frame
Reduced operative time Reduced C-arm exposure time Reduced C-arm exposure	—

Countries

Japan

Contacts

Public ContactJunichi Oyama

Smith & Nephew Orthopaedics KK Clinical Affairs & Ortho Specialties

junichi.oyama@smith-nephew.com03-5403-8259

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026