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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Revision Rate

Timeframe: 1 year

Trial details

NCT IDNCT04865146

SponsorSmith & Nephew Medical (Shanghai) Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-01

View on ClinicalTrials.gov More Femoral Fractures trials