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

Launched by STRYKER TRAUMA AND EXTREMITIES · Jul 8, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for femur fractures using a device called the Femoral Nail GT. The goal is to see how well this device works compared to standard treatments over a 12-month period. The trial will involve about 50 participants who are 18 years or older and have agreed to take part. Eligible individuals are those with certain types of femur fractures, such as those caused by falls or diseases, and they cannot be enrolled in other clinical studies at the same time.

Participants in the trial can expect to receive standard care for their fractures while using the Femoral Nail GT device. They will have follow-up visits over the next year to monitor their recovery and how well the device is performing. Importantly, this study is designed to help surgeons understand if this new treatment is as effective as existing methods, so it could lead to better options for patients with femur fractures in the future.

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 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
• 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).