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 T2 Alpha Tibia Nailing System. Efficacy/performance of the procedure will be measured by an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) score result of the T2 Alpha Tibia Nailing System compared to the T2 Tibia 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 T2 Alpha Tibia Nailing System will be demonstrated through reporting of device related intra-operative and post-operative Adverse Events/incidents by 12 months.
Age
18–99
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 Tibial Nail of the T2 Alpha Tibia Nailing System in accordance with the following legally cleared/ approved Indications for Use:
Indications for Use approved In United States and Canada include:
Open and closed tibial fractures
Pseudoarthrosis and correction osteotomy
Pathologic fractures, impending pathologic fractures and tumor resections
Fractures involving osteopenic and osteoporotic bone
Nonunions and malunions
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 Tibia Fractures With the T2 Alpha Tibia Nailing System
