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

NCT04015167 | Completed Results FDA Device

• 1 other identifier: T2 Alpha Tibia
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 4

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.

Conditions

Tibial Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events

  12 months

• Efficacy/Performance Will be Measured by Demonstration of Bone Consolidation

  12 months

Study Arms (1)

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

Interventions

T2 Alpha Tibia Nailing System DEVICE

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

T2 Alpha Tibia

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (4)

St. Cloud Orthopedic Associates, Ltd

Sartell, Minnesota, 56377, United States

Location

New York University

New York, New York, 10016, United States

Location

UC Health

Cincinnati, Ohio, 45229, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Limitations and Caveats

Assessment of long-term impacts were challenging due to a higher number of loss-to-follow-up, which resulted in missing data and reduced statistical power.

Results Point of Contact

• Title: Monica Fleeman
• Organization: Stryker

monica.fleeman@stryker.com

251-465-5969

Study Officials

• Rebecca Gibson

  Stryker Trauma and Extremities

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: September 12, 2019
• Primary Completion: November 10, 2022
• Study Completion: August 8, 2023
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)