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Depuy Synthes Lower Extremity Shaft Nail Registry

NCT05272631 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 241

Last updated 2026-01-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • DePuy Synthes Products, Inc.

    lead INDUSTRY

Principal Investigators

  • DePuy Synthes Products, Inc. Clinical Trial · DePuy Synthes Products, Inc.

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-04
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05272631 on ClinicalTrials.gov