Phase
Condition
N/ATreatment
Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is a male or non-pregnant female age 18 years or older at the time ofsurgery;
Subject is willing and able to give written informed consent and comply with therequirements of this Clinical Investigation Plan;
Subject is intended to be treated with the Femoral Nail PF of the T2 Alpha FemurAntegrade GT/PF Nailing System in accordance with the following legally cleared/approved Indications for Use:
Indications for Use:
Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminutedproximal femoral shaft fractures
Femoral fixation required as a result of pathological disease
Temporary stabilization of fractures of the femoral shaft ranging from the femoralneck to the supracondylar regions of the femur
Open and closed femoral fractures
Pseudoarthrosis and correction osteotomy
Pathologic fractures, impending pathologic fractures and tumor resections
Ipsilateral femur fractures
Fractures proximal to a total knee arthroplasty
Nonunions and malunions
Fractures involving osteopenic and osteoporotic bone
Exclusion
Exclusion Criteria:
Subject is currently enrolled in or plans to enroll in any concurrent drug and/ordevice clinical investigation that, in the opinion of the Investigator, may confoundresults;
Per the Investigator, the subject is in poor general health or undergoing anyconcurrent disease that would place the subject in excessive risk to surgery (i.e.significant circulatory problems, cardiac disease).
Study Design
Study Description
Connect with a study center
St. Cloud Orthopedic Associates, Ltd
Sartell, Minnesota 56377
United StatesSite Not Available
St. Cloud Orthopedic Associates, Ltd
Sartell 5046001, Minnesota 5037779 56377
United StatesSite Not Available
Reno Orthopedic Clinic
Reno, Nevada 89503
United StatesSite Not Available
Ariana Meltzer-Bruhn
New York, New York 10016
United StatesSite Not Available
NYU Langone Medical Center
New York 5128581, New York 5128638 10016
United StatesSite Not Available
UC Health
Cincinnati, Ohio 45229
United StatesSite Not Available
UC Health
Cincinnati 4508722, Ohio 5165418 45229
United StatesSite Not Available
Inova Fairfax Medical Campus
Falls Church, Virginia 22042
United StatesSite Not Available
Inova Fairfax Medical Campus
Falls Church 4758390, Virginia 6254928 22042
United StatesSite Not Available

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