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

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.

Study Overview

• Status: Completed
• Conditions: Tibial Fractures
• Intervention / Treatment: Device: T2 Alpha Tibia Nailing System

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 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 Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Sartell, Minnesota, United States, 56377
      • St. Cloud Orthopedic Associates, Ltd
  • New York
    • New York, New York, United States, 10016
      • New York University
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • UC Health
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Approximately 80 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for treatment of tibial fractures will be evaluated for clinical investigation participation based on the eligibility criteria.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T2 Alpha Tibia; Subjects in the clinical investigation will undergo placement of the Tibial Nail of the T2 Alpha Tibia Nailing System, according to the approved Instructions for Use and Operative Technique Manual.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary)	The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary). The SF-36 PCS is a self-report measure of health status. SF-36 Physical Component Summary scores range from 0 to 100; higher SF-36 score results are linked to better subject results. 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 T2 Tibia benchmark literature.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events	Incidence of device-related adverse events will be monitored by 12 months through data collection and analyses.	12 months
Efficacy/Performance Will be Measured by Demonstration of Bone Consolidation	Bone consolidation will be assessed by 12 months as measured by Investigator assessment.	12 months

Collaborators and Investigators

• Sponsor: Stryker Trauma and Extremities
• Investigators: Study Director: Rebecca Gibson, Stryker Trauma and Extremities

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2019
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: T2 Alpha Tibia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes