Biodegradable Magnesium Screws for Ankle Fracture

This trial tests new magnesium screws for fixing ankle fractures requiring surgery. These screws dissolve in the body over time, potentially eliminating the need for a second surgery to remove them. The trial evaluates the effectiveness and safety of these screws. Individuals with an unstable ankle fracture needing surgery and willing to attend follow-up visits may be suitable candidates. Participants will undergo regular check-ups and X-rays to monitor healing and screw absorption over a year. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future surgical outcomes.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research has shown that biodegradable magnesium screws, such as the RemeOs screw, are generally safe for ankle fracture surgeries. In earlier studies, patients experienced good bone healing, and the screws gradually dissolved in the body. Importantly, these studies found that after 12 months, patients were pain-free and did not experience issues like discomfort from shoes or bone misalignment.

Unlike the standard metal screws used in ankle fracture surgeries, the RemeOs Magnesium-Based Biodegradable Screw offers a unique advantage by gradually dissolving in the body over time. This eliminates the need for a second surgery to remove the hardware, which is often required with traditional screws. Additionally, magnesium is known for its excellent compatibility with bone tissue, potentially enhancing the healing process. Researchers are excited about this treatment because it promises fewer complications and a more natural healing progression for patients.

Research has shown that biodegradable magnesium screws, such as the RemeOs screw, can effectively treat ankle fractures. In this trial, participants will undergo open reduction and internal fixation (ORIF) of their unstable ankle fracture using RemeOs magnesium-based biodegradable screws. These screws hold the bone in place and gradually dissolve, being absorbed by the body, potentially eliminating the need for a second surgery to remove them. Studies have found that these magnesium screws perform as well as traditional metal screws, both in function and in X-ray results. Additionally, after 12 months, patients reported no pain or issues, such as infection or screw failure. The FDA has approved the magnesium screws, underscoring their safety and potential effectiveness in foot and ankle surgeries.¹²³⁴⁶