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

Tibial Fractures Clinical Trial

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

Clinical Trial 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 and the clinical investigation includes a historical control which will be compared to the T2 Alpha Tibia Nailing System. Total duration of enrollment, 12 month follow-up and analysis is expected to take 31 months. The clinical investigation has been designed to follow the surgeon's standard of care for tibia fractured subjects, in addition to a 12 month follow-up visit. The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the SF-36 Physical Component Summary (PCS). Confirmation of efficacy/performance at 12 months will be based on an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) result of the T2 Alpha Tibia Nailing System compared to the benchmark literature.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04015167
Study type Observational
Source Stryker Trauma GmbH
Contact
Status Completed
Phase
Start date September 12, 2019
Completion date August 8, 2023
View Details
See also
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