Depuy Synthes Lower Extremity Shaft Nail Registry

January 15, 2026 updated by: DePuy Synthes Products, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46278
        • Orthopedic Research Foundation, Inc
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Michigan Medicine; University of Michigan
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • JPS Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes adults 22 years of age or older, (Retrograde Femoral Nail Advanced [RFNA], Tibial Nail Advanced [TNA]) or adolescents 12-21 years of age in which the growth plates have fused (TNA only) who will undergo surgery for fixation and stabilization of a tibia, femoral shaft or distal femur fracture, or who require a revision due to a malunion or a nonunion, with either the TNA (tibia) or RFNA (femoral shaft or distal femur).

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrograde Femoral Nail Advanced (RFNA) Cohort
Participants with a distal femur or femoral shaft fracture or who require revision due to a malunion or nonunion will undergo surgery with RFNA based on surgeon's decision and the site's standard of care (SOC). Participants with impending pathologic fracture are also included.
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.
Tibial Nail Advanced (TNA) Cohort
Participants with open or closed, proximal, distal or shaft fractures of the tibia, or who require revision due to a malunion or nonunion will undergo surgery with TNA based on 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Union
Time Frame: Up to Week 56
Time to union will be reported. Union is defined as a combination of radiographic and clinical assessment, where union will be considered achieved based on radiographic images, and no pain at the fracture site indicative of nonunion.
Up to Week 56
Number of Participants with Union (Healing)
Time Frame: Up to Week 56
Number of participants with union (healing) will be reported. Union is defined as a combination of radiographic and clinical assessment, where union will be considered achieved based on radiographic images, and no pain at the fracture site indicative of nonunion.
Up to Week 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Visual Analogue Scale (VAS) Score
Time Frame: From Week 6 up to Week 52
The VAS is a 100 point one-dimensional line anchored on either end by verbal descriptors ranging from " 0=no pain" to "100=worst pain you can imagine". The higher score indicates greater pain intensity.
From Week 6 up to Week 52
Short Form 12-Item Health Survey (SF-12) Questionnaire Score
Time Frame: From Week 6 up to Week 52
The SF-12 volume-2 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). For each of the 8 domains, the questions are coded, added and transformed on a scale that ranges from 0 (the worst health status for that dimension) to 100 (the best health status).
From Week 6 up to Week 52
Quality of Life as Assessed by European Quality of Life (EuroQoL) 5-Dimensions 5-Levels (EQ-5D-5L) Questionnaire Score: EQ-5D Descriptive System
Time Frame: From Week 6 up to Week 52
EQ-5D-5L is a standardized instrument that was designed for self-completion. EQ-5D-5L consist of EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The scores are applied to population-specific valuations of health states to result in a single index value. The health index scores generally range from less than 0 to 1 with higher scores indicating higher health utility.
From Week 6 up to Week 52
Quality of Life as Assessed by EQ-5D-5L Questionnaire Score: EQ VAS
Time Frame: From Week 6 up to Week 52
EQ-5D-5L is a standardized instrument that was designed for self-completion. EQ-5D-5L consist of EQ-5D descriptive system and the EQ VAS. The EQ VAS records the participant's self-rated health on a vertical visual analogue scale from 0 to 100, where 0 indicate 'The best health you can imagine' and 100 indicate 'The worst health you can imagine'.
From Week 6 up to Week 52
Weight Bearing Status
Time Frame: From Week 2 up to Week 52
Weight bearing status will be categorized as weight-bearing as tolerated (WBAT), limited weight-bearing up to half of the body weight, and no weight bearing.
From Week 2 up to Week 52
Mobility Assessment
Time Frame: Up to Week 56
Mobility assessment including ambulatory/unaided, ambulatory with cane, ambulatory with walker and nonambulatory will be reported.
Up to Week 56
Number of Participants with Revision Surgery
Time Frame: From Week 2 up to Week 52
Number of participants with revision surgery will be reported. It includes the surgery following the index surgery that involves adjustment, modification, removal or replacement of the implanted device or other associated devices used to treat the fracture (nail, screws, endcaps, locking attachment washer [LAW] [Retrograde Femoral Nail Advanced {RFNA} only] or condylar nut and nut and screw washers [RFNA only]).
From Week 2 up to Week 52
Number of Participants with Reoperation
Time Frame: From Week 2 up to Week 52
Number of participants with reoperation will be reported. It is defined as a second operation at the fracture site(s) after the index surgery that does not include adjustment, modification, removal or replacement of the implanted device.
From Week 2 up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Synthes Products, Inc.

Investigators

  • Study Director: DePuy Synthes Products, Inc. Clinical Trial, DePuy Synthes Products, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2022

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DST202103 (Other Identifier: DePuy Synthes Products, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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