Status:
ACTIVE_NOT_RECRUITING
Depuy Synthes Lower Extremity Shaft Nail Registry
Lead Sponsor:
DePuy Synthes Products, Inc.
Conditions:
Femoral Fractures
Tibial Fractures
Eligibility:
All Genders
12+ years
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 Fem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05272631
Start Date
May 4 2022
End Date
December 31 2025
Last Update
December 5 2025
Active Locations (8)
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1
Orthopedic Research Foundation, Inc
Indianapolis, Indiana, United States, 46278
2
Michigan Medicine; University of Michigan
Ann Arbor, Michigan, United States, 48109
3
University of Missouri
Columbia, Missouri, United States, 65211
4
Duke University
Durham, North Carolina, United States, 27705