A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System

Launched by STRYKER TRAUMA AND EXTREMITIES · Jul 8, 2019

Keywords

ClinConnect Summary

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 devi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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).