Clinical trial NCT05272631: Depuy Synthes Lower Extremity Shaft Nail Registry
Official title: Depuy Synthes Lower Extremity Shaft Nail Registry (RFN-Advanced™ Retrograde Femoral Nailing System/ TN-Advanced™ Tibial Nailing System)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Femoral Fractures
Tibial Fractures
Lead sponsor: DePuy Synthes Products, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Union
timeFrame: Up to Week 56
measure: Number of Participants with Union (Healing)
timeFrame: Up to Week 56
Secondary outcomes:
measure: Pain Visual Analogue Scale (VAS) Score
timeFrame: From Week 6 up to Week 52
measure: Short Form 12-Item Health Survey (SF-12) Questionnaire Score
timeFrame: From Week 6 up to Week 52
measure: Quality of Life as Assessed by European Quality of Life (EuroQoL) 5-Dimensions 5-Levels (EQ-5D-5L) Questionnaire Score: EQ-5D Descriptive System
timeFrame: From Week 6 up to Week 52
measure: Quality of Life as Assessed by EQ-5D-5L Questionnaire Score: EQ VAS
timeFrame: From Week 6 up to Week 52
measure: Weight Bearing Status
timeFrame: From Week 2 up to Week 52
measure: Mobility Assessment
timeFrame: Up to Week 56
measure: Number of Participants with Revision Surgery
timeFrame: From Week 2 up to Week 52
measure: Number of Participants with Reoperation
timeFrame: From Week 2 up to Week 52
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Orthopedic Research Foundation, Inc
state: Indiana
city: Ann Arbor
country: United States
facility: Michigan Medicine; University of Michigan
state: Michigan
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: JPS Health Network
state: Texas
Study officials:
affiliation: DePuy Synthes Products, Inc.
name: DePuy Synthes Products, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: EQ-5D-5L User Guide, EuroQol Research Foundation 2019; Version 3.0 Updated Sept. 2019
citation: 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;
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.