Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stryker Trauma and Extremities
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System. Efficacy/performance of the procedure will be measured by an equal or greater (non-inferior) Lower Extremity Measure (LEM) score result of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature at 12 months.
In addition, demonstration of bone consolidation in correct alignment will be measured by Investigator assessment by 12 months. Safety of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System will be demonstrated through reporting of device related intra-operative and post-operative Adverse Events/incidents by 12 months.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject is a male or non-pregnant female age 18 years or older at the time of surgery;
Subject is willing and able to give written informed consent and comply with the requirements of this Clinical Investigation Plan;
Subject is intended to be treated with the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System in accordance with the following legally cleared/ approved Indications for Use:
Femoral fixation required as a result of pathological disease
Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck 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
You may not be if
Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results;
Per the Investigator, the subject is in poor general health or undergoing any concurrent disease that would place the subject in excessive risk to surgery (i.e. significant circulatory problems, cardiac disease).
Clareo Health | A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
