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

NCT ID: NCT04015167

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-12
• Study Completion Date: 2023-08-08

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 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.

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.

Conditions

Tibial Fractures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

T2 Alpha Tibia Nailing System

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Gibson

Role: STUDY_DIRECTOR

Stryker Trauma and Extremities

Locations

St. Cloud Orthopedic Associates, Ltd

Sartell, Minnesota, United States

New York University

New York, New York, United States

UC Health

Cincinnati, Ohio, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

T2 Alpha Tibia

Identifier Type: -

Identifier Source: org_study_id