A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF

NCT04015154 | Completed FDA Device

• 1 other identifier: T2 Alpha Femur Antegrade PF
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 4

Brief Summary

This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of 50 subjects will be enrolled at up to 5 sites. Enrollment is estimated to commence in Q4 of 2018. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System. Total duration of enrollment, 12 month follow-up and analysis is expected to take 29 months. The clinical investigation has been designed to follow the surgeon's standard of care for femur 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 Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.

Conditions

Femoral Fracture

Outcome Measures

Primary Outcomes (1)

• Lower Extremity Measure (LEM)

  The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur 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 Femoral Nail PF

Subjects in the clinical investigation will undergo placement of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System which allows for insertion through the piriformis fossa, according to the Instructions for Use and Operative Technique Manual

Device: Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System

Interventions

Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System DEVICE

The T2 Alpha Femur Antegrade GT / PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.

T2 Alpha Femoral Nail PF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Approximately 50 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 femoral 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 Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System in accordance with the following legally cleared/ approved Indications for Use:
• Indications for Use:
• Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
• Femoral fixation required as a result of pathological disease
• Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Nonunions and malunions
• Fractures involving osteopenic and osteoporotic bone

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

NYU Langone Medical Center

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

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Rebecca Gibson

  Stryker Trauma and Extremities

  STUDY DIRECTOR

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: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)