Evaluation of Femoral Nail PF for treating femur fractures

A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail Piriformis Fossa (PF) of the T2 Alpha Femur Antegrade GT/PF Nailing System

This study is testing a new device called the Femoral Nail PF to see if it safely helps people with femur fractures heal better compared to past treatments.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Stryker Trauma and Extremities (Industry-sponsored)
• Locations: 5 sites (Sartell, Minnesota and 4 other locations)
• Trial ID: NCT04015154 on ClinicalTrials.gov

What this trial studies

This clinical investigation is a prospective, multicenter evaluation aimed at assessing the safety and efficacy of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System for treating femoral fractures. A total of 50 subjects will be enrolled across up to 5 sites, with a follow-up period of 12 months to measure outcomes. The primary endpoint is to confirm that the performance of the Femoral Nail PF is non-inferior to historical benchmarks, as assessed by the Lower Extremity Measure (LEM) score. Additionally, the study will evaluate bone consolidation and report any device-related adverse events.

Who should consider this trial

Good fit: Ideal candidates include males and non-pregnant females aged 18 and older who require surgical treatment for various types of femoral fractures.

Not a fit: Patients with contraindications to the Femoral Nail PF or those who are not surgical candidates may not benefit from this study.

Why it matters

Potential benefit: If successful, this investigation could provide a safer and more effective treatment option for patients with femoral fractures.

How similar studies have performed: Other studies have shown success with similar fixation devices, indicating a promising approach for treating femoral fractures.

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 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

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).

Where this trial is running

Sartell, Minnesota and 4 other locations

• St. Cloud Orthopedic Associates, Ltd — Sartell, Minnesota, United States (Completed)
• Reno Orthopedic Clinic — Reno, Nevada, United States (Recruiting)
• Ariana Meltzer-Bruhn — New York, New York, United States (Recruiting)
• UC Health — Cincinnati, Ohio, United States (Completed)
• Inova Fairfax Medical Campus — Falls Church, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Monica Fleeman

Conditions Femoral Fracture