A Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ (10S Models) (NCT04865146) | Clinical Trial Compass
WithdrawnNot Applicable
A Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ (10S Models)
Stopped: Change on clinical and marketing strategy for intramedullary devices
China0Started 2022-06-23
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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).…