Procedures

Vertebral Augmentation

Vertebral compression fractures occur when the bone of the vertebral body collapses. These fractures are often caused by osteoporosis and less commonly by trauma or tumors. With the use of the NeuroTherm Parallax® product line, physicians can offer a minimally invasive treatment for the stabilization of vertebral compression fractures. Vertebral compression fractures can be treated with either vertebroplasty or vertebral augmentation. Vertebral augmentation consists of first creating a cavity in the vertebral body with either a vertebral balloon or mechanical osteotome. Once the cavity has been created, Parallax® TRACERS® Bone Cement is injected into the vertebral body. Once hardened, the cement provides stabilization to the fracture and thus reduces pain for the patient.

Vert AugAn access needle, cavity creation device, Parallax bone cement, and the EZFlow® Cement Delivery System are used to perform the procedure.

Procedure

  1. Patient is placed in the prone position. A pillow may be placed under the abdomen to alleviate discomfort and to provide the physician with better anatomical access
  2. Using fluoroscopy, an anterior-posterior (AP) view is taken of the spine in order to locate the vertebral compression fracture
  3. The treatment area is sterilized and a local anesthetic may be used to numb the skin and soft tissue
  4. A vertebral access needle is inserted and guided through the pedicle into the damaged vertebral body (placement of the needle is confirmed with both an AP and lateral view)
  5. The stylet of the access needle is removed and the cavity creation device is inserted
  6. During needle placement or cavity creation, the bone cement should be mixed and allowed to rest until the ideal consistency is achieved
  7. The vertebral balloon is inflated or the mechanical osteotome is used to create the ideal cavity
  8. Following cavity creation, the cavity creation device is removed from the access needle
  9. Assemble the cement delivery system, load the cement, and prime the Conduit until cement exits the distal tip
  10. Connect the cement delivery system to the Conduit, insert the Conduit into the vertebral access needle, and begin to inject bone cement into the vertebral body while carefully monitoring cement distribution under fluoroscopy
  11. Once the desired volume of cement is achieved, detach the cement delivery system and slowly remove the access needle
  12. A bandage is placed over the needle insertion site
  13. Patient should limit movement for approximately 20 minutes to allow for the cement to set

This procedure description is not intended for use as a medical guide. Please consult he appropriate Instructions for Use before using any NeuroTherm products.

Parallax, TRACERS, and EZFlow are registered trademarks of NeuroTherm, Inc.