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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 Year(s) - 99 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants who are male or non-pregnant female aged 18 years or older at the time of surgery
    2. Participants who can provide written informed consent and comply with the requirements of the study protocol
    3. Participants 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:
      • 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 thefemoral 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 be eligible for this study if the following are true:

    1. Active or suspected latent infection or marked local inflammation in or about the affected area
    2. Has lack of adequate blood supply to the operative site
    3. Has allergy or sensitivity to the materials
    4. Participants who are obese
    5. Has inadequate tissue coverage over the operative site.
    6. Has mental or neuromuscular disorder
    7. Participants who have any other medical or surgical condition which would preclude the potential benefit of surgery
    8. Has documented bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and / or fixation of the device
    9. has implant utilization that would interfere with anatomical structures or physiological performance

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