NCT05272631

Depuy Synthes Lower Extremity Shaft Nail Registry

Depuy Synthes Lower Extremity Shaft Nail Registry (RFN-Advanced™ Retrograde Femoral Nailing System/ TN-Advanced™ Tibial Nailing System)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 241 (actual)
• Sponsor: DePuy Synthes Products, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA) and TN-Advanced Tibial Nailing System (TNA) in participants who have experienced femoral or tibial fractures, respectively, requiring fixation and stabilization or who require a revision due to a malunion or a nonunion.

Conditions

• Femoral Fractures
• Tibial Fractures

Interventions

Type	Name	Description
DEVICE	Retrograde Femoral Nail Advanced	No drug will be given as part of this study. Participant will undergo surgery with RFNA based on the surgeon's decision and the site's SOC.
DEVICE	Tibial Nail Advanced	No drug will be given as part of this study. Participant will undergo surgery with TNA based on the surgeon's decision and the site's SOC.

Timeline

• Start date: 2022-05-04
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2022-03-09
• Last updated: 2026-01-16

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study