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

Launched by STRYKER TRAUMA AND EXTREMITIES · Jul 8, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for femur fractures, which are breaks in the thigh bone. The researchers want to see how well the Femoral Nail PF device works over a 12-month period. They plan to enroll about 50 participants from up to five different sites. The trial will compare the results of the Femoral Nail PF to previous treatments to see if it provides similar or better outcomes for patients.

To participate, individuals must be at least 18 years old, not pregnant, and able to give consent for the study. They should be undergoing surgery that involves using the Femoral Nail PF for specific types of femur fractures. Participants will receive the standard care for their condition, and they will attend follow-up visits for a year to monitor their progress. Importantly, those with serious health issues or participating in other clinical trials may not be eligible. Overall, this trial aims to ensure that the new device is safe and effective for treating femur fractures.

Gender

ALL

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).