Depuy Synthes Lower Extremity Shaft Nail Registry

Last updated: January 15, 2026
Sponsor: DePuy Synthes Products, Inc.
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Retrograde Femoral Nail Advanced

Tibial Nail Advanced

Clinical Study ID

NCT05272631
DST202103
DST202103
  • Ages > 12
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Skeletally mature adults age greater than or equal to (>=) 22 years (RetrogradeFemoral Nail Advanced [RFNA], Tibial Nail Advanced [TNA]) and adolescents 12-21years 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 orbilateral tibial fracture (TNA); revision of malunion or nonunion of previousfracture, or impending pathologic fracture (RFNA only) that will be treatedoperatively as part of standard of care. In addition, the following will beincluded: a) RFNA only: femoral shaft or distal femur fracture can be periprosthetic (PPFx) fracture after total or unicondylar knee arthroplasty, or total or hemi hiparthroplasty 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 anavailable translated language for patient reported outcomes (PROs)

Exclusion

Exclusion Criteria:

  • Participation in any other medical device or medicinal product study within theprevious month. Participation in observational studies is allowed

  • In the opinion of the Principal Investigator, participant is unable to comply withthe requirements of the Registry

  • Participant has known allergies to implant components

Study Design

Total Participants: 241
Treatment Group(s): 2
Primary Treatment: Retrograde Femoral Nail Advanced
Phase:
Study Start date:
May 04, 2022
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Orthopedic Research Foundation, Inc

    Indianapolis, Indiana 46278
    United States

    Site Not Available

  • Orthopedic Research Foundation, Inc

    Indianapolis 4259418, Indiana 4921868 46278
    United States

    Site Not Available

  • Michigan Medicine; University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Michigan Medicine; University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • University of Missouri

    Columbia, Missouri 65211
    United States

    Site Not Available

  • University of Missouri

    Columbia 4381982, Missouri 4398678 65211
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Duke University

    Durham 4464368, North Carolina 4482348 27705
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Site Not Available

  • OhioHealth Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • JPS Health Network

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • JPS Health Network

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Site Not Available

  • Inova Fairfax Medical Campus

    Falls Church, Virginia 22042
    United States

    Site Not Available

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