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 Type
OBSERVATIONAL
Enrollment
241
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.
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.
Orthopedic Research Foundation, Inc
Indianapolis, Indiana, United States
Michigan Medicine; University of Michigan
Ann Arbor, Michigan, United States
University of Missouri
Columbia, Missouri, United States
Duke University
Durham, North Carolina, United States
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.
Time frame: 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.
Time frame: Up to Week 56
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.
Time frame: 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).
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
JPS Health Network
Fort Worth, Texas, United States
Time frame: 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'.
Time frame: 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.
Time frame: 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.
Time frame: 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 \[RFNA only\]).
Time frame: 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.
Time frame: From Week 2 up to Week 52