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Femoral FracturesNCT05272631

Depuy Synthes Lower Extremity Shaft Nail Registry

An observational study of Femoral Fractures and Tibial Fractures, run by DePuy Synthes Products, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Femoral Fractures, Tibial Fractures
What is being tested?
Retrograde Femoral Nail Advanced and Tibial Nail Advanced
Type of treatment
Medical device
How many people
241 participants
Where
8 sitesUnited States
Study dates
4 May 2022to 31 Oct 2025
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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).

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Michigan Medicine; University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Missouri

    Columbia, Missouri, 65211

  • Duke University

    Durham, North Carolina, 27705

  • JPS Health Network

    Fort Worth, Texas, 76104

  • Orthopedic Research Foundation, Inc

    Indianapolis, Indiana, 46278

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Being tested
Retrograde Femoral Nail Advanced, Tibial Nail Advanced
Medical subject headings
Femoral Fractures, Tibial Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retrograde Femoral Nail AdvancedDevice

    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 AdvancedDevice

    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.

Study groups in NCT05272631
Study groupRoleWhat they receive
Retrograde Femoral Nail Advanced (RFNA) CohortParticipants 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.
Receives: Device: Retrograde Femoral Nail Advanced
Tibial Nail Advanced (TNA) CohortParticipants 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.
Receives: Device: Tibial Nail Advanced

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Union

    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.

    Measured: Up to Week 56

  2. Number of Participants with Union (Healing)

    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.

    Measured: Up to Week 56

Secondary outcomes (8)

  1. Pain Visual Analogue Scale (VAS) Score

    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.

    Measured: From Week 6 up to Week 52

  2. Short Form 12-Item Health Survey (SF-12) Questionnaire Score

    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).

    Measured: From Week 6 up to Week 52

  3. Quality of Life as Assessed by European Quality of Life (EuroQoL) 5-Dimensions 5-Levels (EQ-5D-5L) Questionnaire Score: EQ-5D Descriptive System

    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.

    Measured: From Week 6 up to Week 52

  4. Quality of Life as Assessed by EQ-5D-5L Questionnaire Score: EQ VAS

    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'.

    Measured: From Week 6 up to Week 52

  5. Weight Bearing Status

    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.

    Measured: From Week 2 up to Week 52

  6. Mobility Assessment

    Mobility assessment including ambulatory/unaided, ambulatory with cane, ambulatory with walker and nonambulatory will be reported.

    Measured: Up to Week 56

  7. Number of Participants with Revision Surgery

    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]).

    Measured: From Week 2 up to Week 52

  8. Number of Participants with Reoperation

    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.

    Measured: From Week 2 up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start4 May 2022
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
241 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05272631
Sponsor's protocol ID
DST202103
Other IDs
DST202103
Status last verified
Jan 2026
First submitted
28 Feb 2022
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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

Publications

  • Beak P, Moudhgalya S, Anderson T, Hing CB. Painful locking screws with tibial nailing, an underestimated complication. Eur J Orthop Surg Traumatol. 2019 Dec;29(8):1795-1799. doi: 10.1007/s00590-019-02501-8. Epub 2019 Jul 16.

    PubMed 31312954

  • Byun SE, Shon HC, Park JH, Oh HK, Cho YH, Kim JW, Sim JA. Incidence and risk factors of knee injuries associated with ipsilateral femoral shaft fractures: A multicentre retrospective analysis of 429 femoral shaft injuries. Injury. 2018 Aug;49(8):1602-1606. doi: 10.1016/j.injury.2018.06.006. Epub 2018 Jun 4.

    PubMed 29887503

  • Capone A, Congia S, Civinini R, Marongiu G. Periprosthetic fractures: epidemiology and current treatment. Clin Cases Miner Bone Metab. 2017 May-Aug;14(2):189-196. doi: 10.11138/ccmbm/2017.14.1.189. Epub 2017 Oct 25.

    PubMed 29263732

  • Cereijo C, Attum B, Rodriguez-Buitrago A, Jahangir AA, Obremskey W. Intramedullary Nail Fixation of Tibial Shaft Fractures: Suprapatellar Approach. JBJS Essent Surg Tech. 2018 Sep 12;8(3):e24. doi: 10.2106/JBJS.ST.17.00063. eCollection 2018 Sep 28.

    PubMed 30588369

  • Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.

    PubMed 16814787

  • Court-Brown CM. The epidemiology of fractures and dislocations. In: Court-Brown CM, Heckman JD, Mcqueen MM, et al, eds. Rockwood and Green's Fractures in Adults. 8th ed. Philadelphia, PA: Wolters Kluwer Health; 2015:59-108

  • EQ-5D-5L User Guide, EuroQol Research Foundation 2019; Version 3.0 Updated Sept. 2019

  • Finkemeier, C et al. (2020a, August 30). RFN-Advanced Retrograde Femoral Nailing System. https://approvedsolutions.aofoundation.org/approvedsolutionsfolder/2020/rfn-advancedretrograde- femoral-nailing-system#tab=details TN- Advanced Tibial Nailing System https://approvedsolutions.aofoundation.org/approvedsolutionsfolder/2020/t -advanced-tibialnailing- system#tab=details;

  • Finkemeier, C et al. (2020b, November 24) Advanced Nailing System. AO Innovations Magazine 2020. https://issuu.com/aofoundation/docs/aoe_tc_innovations_24_11_2020_final

  • He GC, Wang HS, Wang QF, Chen ZH, Cai XH. Effect of minimally invasive percutaneous plates versus interlocking intramedullary nailing in tibial shaft treatment for fractures in adults: a meta-analysis. Clinics (Sao Paulo). 2014;69(4):234-40. doi: 10.6061/clinics/2014(04)03.

    PubMed 24714830

  • Lee C, Zoller SD, Perdue PW Jr, Nascone JW. Pearls and Pitfalls With Intramedullary Nailing of Proximal Tibia Fractures. J Am Acad Orthop Surg. 2020 Jan 15;28(2):66-73. doi: 10.5435/JAAOS-D-18-00765.

    PubMed 31884503

  • Meena RC, Meena UK, Gupta GL, Gahlot N, Gaba S. Intramedullary nailing versus proximal plating in the management of closed extra-articular proximal tibial fracture: a randomized controlled trial. J Orthop Traumatol. 2015 Sep;16(3):203-8. doi: 10.1007/s10195-014-0332-9. Epub 2015 Jan 15.

    PubMed 25588847

  • Oak SR, Strnad GJ, Bena J, Farrow LD, Parker RD, Jones MH, Spindler KP. Responsiveness Comparison of the EQ-5D, PROMIS Global Health, and VR-12 Questionnaires in Knee Arthroscopy. Orthop J Sports Med. 2016 Dec 17;4(12):2325967116674714. doi: 10.1177/2325967116674714. eCollection 2016 Dec.

    PubMed 28210645

  • Rodriguez EK, Boulton C, Weaver MJ, Herder LM, Morgan JH, Chacko AT, Appleton PT, Zurakowski D, Vrahas MS. Predictive factors of distal femoral fracture nonunion after lateral locked plating: a retrospective multicenter case-control study of 283 fractures. Injury. 2014 Mar;45(3):554-9. doi: 10.1016/j.injury.2013.10.042. Epub 2013 Nov 4.

    PubMed 24275357

  • Yoon BH, Park IK, Kim Y, Oh HK, Choo SK, Sung YB. Incidence of nonunion after surgery of distal femoral fractures using contemporary fixation device: a meta-analysis. Arch Orthop Trauma Surg. 2021 Feb;141(2):225-233. doi: 10.1007/s00402-020-03463-x. Epub 2020 May 9.

    PubMed 32388648

Questions about this trial

What is this clinical trial studying?

An observational study of Femoral Fractures and Tibial Fractures, run by DePuy Synthes Products, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Union (time frame: Up to Week 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05272631, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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