Status:
COMPLETED
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
Lead Sponsor:
Stryker Trauma and Extremities
Conditions:
Tibial Fractures
Eligibility:
All Genders
18-99 years
Brief Summary
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment an...
Detailed Description
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 eq...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 8 2023
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04015167
Start Date
September 12 2019
End Date
August 8 2023
Last Update
January 6 2025
Active Locations (4)
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1
St. Cloud Orthopedic Associates, Ltd
Sartell, Minnesota, United States, 56377
2
New York University
New York, New York, United States, 10016
3
UC Health
Cincinnati, Ohio, United States, 45229
4
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042