Spinal Fusion Clinical Trials

Active_comparator: O-Arm neuronavigator

The O-ARM imaging system can help surgeons to view the spine in real time and verify the placement of implants such as screws or rods. Primarily, therefore, in image acquisition, during surgery, the O-ARM is activated and generates real-time images of the patient's spine, so that these images are displayed on a screen, allowing the surgeon to visualize the anatomical structures and check that implant placement is proper. Therefore, when analyzing these images, the surgeon can, for example, analyze and verify the placement of the implants and ensure that the arthrodesis is performed correctly, in such a way that, if necessary, the surgeon can make adjustments and then acquire new images for verification.

Placebo_comparator: Conventional

The conventional procedure for spinal arthrodesis will involve the intervertebral disc removal step between the vertebrae that will be fused. This is done precisely to create space for the bone graft that will be placed later. Then, there is bone surface preparation, where you prepare the bone surfaces of the vertebrae that will be fused, removing any soft tissue that might interfere with bone fusion. Then, there is bone graft placement, where the surgeon places a bone graft between the vertebrae that will be fused together. This graft can be obtained from another part of the patient's body (such as the pelvis) or from a deceased donor. Then, in the spinal column fixation step, rods, screws and/or plates are used to fix the vertebrae that will be fused.