A Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ (10S Models)

A Multicenter, Post Market, Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ Intertrochanteric Antegrade Nails (10S Models) for the Treatment of Femoral Fracture in Chinese Subjects

This is a post-market study to evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation. The study will enroll Approximately 180 subjects with femoral fractures, Approximately 7 sites are involved. The study duration will be Approximately 36 months (6 months start-up, 1 year enrollment, 1 year follow-up, 6 months closeout/study report).

Background:

The INTERTAN nail was designed to improve upon existing intramedullary nail systems. INTERTAN nails utilize two interlocking screws, thereby improving controlled intertochanteric fracture compression and post-surgical stability.

Purpose:

Evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation

Objectives:

• Primary Objective: To evaluate the revision rate for any reason of femoral fractures, treated with INTERTAN 10S Nails at one year post-operation
• Secondary Objective: To generate safety and effectiveness evidence for INTERTAN 10S Nails via the collection of functional outcomes, quality of life, and safety data

Research participants / locations:

The study will enroll Approximately 180 subjects with femoral fractures, Approximately 7 sites in China are involved.

Inclusion Criteria:

• Subjects who sign the informed consent form (ICF) voluntarily.
• Subjects who have a femoral fracture and are scheduled for repair using an INTERTAN 10S Nail.
• Male or female subjects aged 18 years or older, with mature bone development at time of implantation.
• Subjects who agree to follow all study visits and procedures.

Exclusion Criteria:

• Subjects with known hypersensitivity to the device or implant materials.
• Subjects in which use of the device would cross open epiphyseal plate(s).
• Subjects with complex intertrochanteric and femoral neck fractures.
• Subjects with an existing condition that predisposes them to a poor outcome, such as blood supply limitations, insufficient bone quality or quantity, obliterated medullary canal, previous infections or other conditions which tend to retard healing.
• Subjects not suitable for operation due to obvious local or systemic infection.
• Subjects who are unable to tolerate anesthesia and surgery due to cardiopulmonary failure or other serious diseases.
• Subjects with a congenital or acquired bony deformity.
• Subjects with Body Mass Index (BMI) of ≥ 35.
• Subjects with hypovolemia, hypothermia, or coagulopathy.
• Subject is immunosuppressed, has an autoimmune disorder or an immunosuppressive disorder. For examples, subjects are on immunosuppressive therapy (cortisol at large dose, cytotoxic drugs, antilymphocytic serum or irradiation at large doses) or has acquired immunodeficiency syndrome (AIDS).
• Subjects with any existing hardware that would preclude the use of the nail.
• Subjects with mental or emotional conditions or any other clinical conditions that, in the opinion of the Investigator, would preclude cooperation and compliance with the rehabilitation regimen.
• Subjects with medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
• Subject is a woman who is pregnant or lactating, or intends to become pregnant during the course of the study follow-up.
• Subjects who have participated in any other clinical trial within 3 months of Screening.
• Subjects who have participated previously in this clinical study and were withdrawn for any reason.