Depuy Synthes Lower Extremity Shaft Nail Registry

Launched by DEPUY SYNTHES PRODUCTS, INC. · Feb 28, 2022

Keywords

ClinConnect Summary

The DePuy Synthes Lower Extremity Shaft Nail Registry is a clinical trial that aims to gather information about the safety and effectiveness of two specific types of nails used to treat fractures in the thigh (femur) and shin (tibia). These nails, called the RFN-Advanced Retrograde Femoral Nailing System and the TN-Advanced Tibial Nailing System, help to stabilize broken bones so they can heal properly. The study will look at how well these nails work by monitoring how quickly patients recover and whether their bones heal as expected.

To be eligible for the trial, participants must be at least 22 years old or between 12 and 21 years old (if their growth plates are closed) and have specific types of fractures that require surgery. They should also be able to understand the study information, either themselves or through a guardian if they are minors. If someone joins the study, they can expect close monitoring of their healing process and their experiences will be recorded to help improve future treatments. It's important to note that participants should not be involved in other studies about medical devices at the same time, and they should not have known allergies to the materials used in the implants.

Gender

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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