Depuy Synthes Lower Extremity Shaft Nail Registry

Study Overview
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Brief Summary
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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.

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

Conditions
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Femoral Fractures, Tibial Fractures

Intervention / Treatment
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* Device: Retrograde Femoral Nail Advanced
* Device: Tibial Nail Advanced


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrograde Femoral Nail Advanced (RFNA) Cohort<br>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<br>* 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.<br>|
| Tibial Nail Advanced (TNA) Cohort<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From Week 6 up to Week 52 | 
| 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). | 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 | 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 | 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 | 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 | 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 | 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 | 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 |