Depuy Synthes Lower Extremity Shaft Nail Registry

Completed

Conditions studied: Femoral Fractures, Tibial Fractures

In brief

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.

Key facts

Study ID

NCT05272631

Run by

DePuy Synthes Products, Inc.

People needed

241

Starts

2022-05-04

Expected to finish

2025-10-31

Last updated by the study team

2026-01-16

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Skeletally mature adults age greater than or equal to (>=) 22 years (Retrograde Femoral Nail Advanced [RFNA], Tibial Nail Advanced [TNA]) and adolescents 12-21 years of age in which the growth plates have fused (TNA only)
• Participant receives an RFNA and/or TNA based on a diagnosis of open or closed, unilateral or bilateral femoral shaft or distal femur fracture (RFNA); unilateral or bilateral tibial fracture (TNA); revision of malunion or nonunion of previous fracture, or impending pathologic fracture (RFNA only) that will be treated operatively as part of standard of care. In addition, the following will be included: a) RFNA only: femoral shaft or distal femur fracture can be periprosthetic (PPFx) fracture after total or unicondylar knee arthroplasty, or total or hemi hip arthroplasty requiring nail osteosynthesis
• Participant (legally authorized representative if participant is a minor) voluntarily signs the Institutional Review Board (IRB)/ Ethics committee (EC) approved consent form
• Participant must be able to read and understand questions and responses in an available translated language for patient reported outcomes (PROs)

You may not qualify if…

• Participation in any other medical device or medicinal product study within the previous month. Participation in observational studies is allowed
• In the opinion of the Principal Investigator, participant is unable to comply with the requirements of the Registry
• Participant has known allergies to implant components

Where it is running

• Orthopedic Research Foundation, Inc — Indianapolis, Indiana, United States
• Michigan Medicine; University of Michigan — Ann Arbor, Michigan, United States
• University of Missouri — Columbia, Missouri, United States
• Duke University — Durham, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• JPS Health Network — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.