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

Completed

Conditions studied: Femoral Fracture

In brief

This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 50 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 Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System. Total duration of enrollment, 12 month follow-up and analysis is expected to take 25 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 GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.

Key facts

Study ID

NCT04015128

Run by

Stryker Trauma and Extremities

People needed

66

Starts

2019-09-12

Expected to finish

2026-04-16

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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 GT of the T2 Alpha Femur Antegrade GT/PF Nailing System in accordance with the following legally cleared/ approved Indications for Use:
• Indications for Use approved Outside of Europe include:
• 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).

Where it is running

• St. Cloud Orthopedic Associates, Ltd — Sartell, Minnesota, United States
• Reno Orthopedic Clinic — Reno, Nevada, United States
• NYU Langone Medical Center — New York, New York, United States
• UC Health — Cincinnati, Ohio, United States
• Regional One Health — Memphis, Tennessee, United States
• Inova Fairfax Medical Campus — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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