Depuy Synthes Lower Extremity Shaft Nail Registry

NCT05272631 | Completed FDA Device

• 1 other identifier: DST202103
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 8

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to Week 56

• 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.

  Up to Week 56

Secondary Outcomes (8)

• Pain Visual Analogue Scale (VAS) Score

  From Week 6 up to Week 52

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

  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

  From Week 6 up to Week 52

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

  From Week 6 up to Week 52

• Weight Bearing Status

  From Week 2 up to Week 52

Study Arms (2)

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

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

Interventions

Retrograde Femoral Nail Advanced DEVICE

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.

Retrograde Femoral Nail Advanced (RFNA) Cohort

Tibial Nail Advanced DEVICE

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.

Tibial Nail Advanced (TNA) Cohort

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

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

Sponsors & Collaborators

• DePuy Synthes Products, Inc.: lead

Study Sites (8)

Orthopedic Research Foundation, Inc

Indianapolis, Indiana, 46278, United States

Location

Michigan Medicine; University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Missouri

Columbia, Missouri, 65211, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

JPS Health Network

Fort Worth, Texas, 76104, United States

Location

Related Publications (15)

• 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.

  PMID: 31312954 BACKGROUND

• 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.

  PMID: 29887503 BACKGROUND

• 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.

  PMID: 29263732 BACKGROUND

• 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.

  PMID: 30588369 BACKGROUND

• 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.

  PMID: 16814787 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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;

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 24714830 BACKGROUND

• 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.

  PMID: 31884503 BACKGROUND

• 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.

  PMID: 25588847 BACKGROUND

• 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.

  PMID: 28210645 BACKGROUND

• 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.

  PMID: 24275357 BACKGROUND

• 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.

  PMID: 32388648 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures; Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• DePuy Synthes Products, Inc. Clinical Trial

  DePuy Synthes Products, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: May 4, 2022
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (8)