Phase
Condition
N/ATreatment
Retrograde Femoral Nail Advanced
Tibial Nail Advanced
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Skeletally mature adults age greater than or equal to (>=) 22 years (RetrogradeFemoral Nail Advanced [RFNA], Tibial Nail Advanced [TNA]) and adolescents 12-21years 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 orbilateral tibial fracture (TNA); revision of malunion or nonunion of previousfracture, or impending pathologic fracture (RFNA only) that will be treatedoperatively as part of standard of care. In addition, the following will beincluded: a) RFNA only: femoral shaft or distal femur fracture can be periprosthetic (PPFx) fracture after total or unicondylar knee arthroplasty, or total or hemi hiparthroplasty 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 anavailable translated language for patient reported outcomes (PROs)
Exclusion
Exclusion Criteria:
Participation in any other medical device or medicinal product study within theprevious month. Participation in observational studies is allowed
In the opinion of the Principal Investigator, participant is unable to comply withthe requirements of the Registry
Participant has known allergies to implant components
Study Design
Connect with a study center
Orthopedic Research Foundation, Inc
Indianapolis, Indiana 46278
United StatesSite Not Available
Orthopedic Research Foundation, Inc
Indianapolis 4259418, Indiana 4921868 46278
United StatesSite Not Available
Michigan Medicine; University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Michigan Medicine; University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
University of Missouri
Columbia, Missouri 65211
United StatesSite Not Available
University of Missouri
Columbia 4381982, Missouri 4398678 65211
United StatesSite Not Available
Duke University
Durham, North Carolina 27705
United StatesSite Not Available
Wake Forest Baptist Health
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Duke University
Durham 4464368, North Carolina 4482348 27705
United StatesSite Not Available
Wake Forest Baptist Health
Winston-Salem 4499612, North Carolina 4482348 27157
United StatesSite Not Available
OhioHealth Research Institute
Columbus, Ohio 43214
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
JPS Health Network
Fort Worth, Texas 76104
United StatesSite Not Available
JPS Health Network
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
Inova Fairfax Medical Campus
Falls Church, Virginia 22042
United StatesSite Not Available

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