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

NCT04015167 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 103

Last updated 2025-01-06

Study results available
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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.

Conditions

  • Tibial Fractures

Interventions

DEVICE

T2 Alpha Tibia Nailing System

The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Rebecca Gibson · Stryker Trauma and Extremities

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2022-11-10
Completion
2023-08-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04015167 on ClinicalTrials.gov