Evaluation of Femoral Nail PF for treating femur fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Monica Fleeman
• Email: monica.fleeman@stryker.com
• Phone: 251 465 5969

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.