Spinal Fusion Study

(FUSION Trial)

This trial aims to gather information on patients who have had specific spinal fusion devices implanted. It will involve observing and collecting data from those who received the Minuteman G5, Liberty, or Patriot devices in their lower back or sacroiliac areas (a joint near the base of the spine). The trial targets individuals who had these devices implanted between April 2022 and March 2025. Participants must be able to provide consent and engage in study activities, which may include undergoing a CT scan. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance future spinal fusion treatments.

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 devices used for spinal fusion, such as the Minuteman G5 and Liberty sacroiliac fusion device, are generally safe. Studies have tested the Minuteman G5 for safety and effectiveness, finding that patients typically tolerate these devices well, with no major issues reported. The FDA has approved the Minuteman G5, indicating it meets specific safety standards for treating certain conditions. This approval provides reassurance about its safety. However, individual experiences may vary, so discussing potential risks with a healthcare provider is always advisable.¹²³⁴⁵

The Minuteman G5 MIS fusion plate, along with the Liberty and Patriot sacroiliac fusion devices, are unique because they offer a minimally invasive approach to spinal fusion, which can potentially reduce recovery times and minimize surgical risks compared to traditional open fusion surgeries. These devices are designed to stabilize the spine while preserving more of the patient's natural anatomy. Researchers are excited because this approach could lead to less postoperative pain and quicker return to daily activities, making it a promising alternative to existing fusion techniques.

Research has shown that devices like the Minuteman G5 and Liberty sacroiliac fusion device can relieve pain and improve spine function. These devices stabilize and immobilize parts of the spine, aiding bone fusion. Studies have found that patients often experience less pain and improved mobility after using these devices. This trial will evaluate participants who have previously received implants such as the Minuteman G5, Liberty sacroiliac fusion device, and/or the Patriot sacroiliac fusion device. The Minuteman device, in particular, is noted for providing relief and enhancing the quality of life for individuals with spine issues. Overall, evidence suggests these devices can improve spine health and reduce discomfort.¹²⁶⁷⁸