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Vertebroplasty

Vertebroplasty

Benefits

  • Pain relief1234
  • Increased range of motion134
  • Return to previous levels of activity134
  • Improved quality of life1345
  • Low complication rate3467
  • Outpatient procedure: no overnight hospital stay
  • No general anesthesia

Vertebroplasty uses a specially formulated acrylic bone cement to stabilize and strengthen the fracture and vertebral body. It’s done on an outpatient basis and requires only a local anesthetic and mild sedation, eliminating the complications that may result from open surgery and general anesthesia. Vertebroplasty is considered a minimally invasive procedure because it is done through a small puncture in the patient’s skin (as opposed to an open incision). Technically simple, it usually takes about 30 minutes to complete.

Using sterile technique and fluoroscopic visualization, a 10-, 11- or 13- gauge needle is advanced into the fractured vertebra using a transpedicular approach. Bi-pedicular needle placement is recommended.8 Once the needles are in the correct position, bone cement is slowly injected into the vertebral body, diffusing throughout the intertrabecular marrow space and creating an internal cast that stabilizes the bone.

Following the procedure, patients lie flat on their back for a short period of time as the cement continues to harden. They may then go home. Most patients undergoing Stryker vertebroplasty experience 90% or better reduction in pain within 24-48 hours and increased ability to perform daily activities shortly thereafter.9

Vertebroplasty is a well-established treatment of vertebral compression fractures (VCFs). Over 20 years of clinical studies have demonstrated positive outcomes following vertebroplasty (percutaneous vertebroplasty) for the treatment of vertebral compression fractures. These include:

Documented clinical outcomes

The Vertos II study conducted by C Klazen, P Lohle, J de Vries, et al 17 found vertebroplasty to be safe, effective, and at an acceptable cost for patients with acute osteoporotic VCFs. Additionally, the study concluded that vertebroplasty gives greater pain relief than conservative treatments.

A study by ME Jensen, AJ Evans, JM Mathis, DF Kallmes, HJ Cloft, and JE Dion9showed that 90% of patients (29 patients with 47 fractures) suffering from age-related or steroid-induced osteoporosis experienced pain relief and improved mobility at 24 hours post-vertebroplasty.

An open prospective study by B Cortet, A Cotton, N Bourtry, RM Flipo, B Duquesnoy, and P Chastanet18reported significant pain reduction and improvement in health profile scores of 16 patients treated at 20 vertebral levels.

A third study by A Cotton, F Dewatre, B Cortet, R Assaker, D Leblond, and B Duquesnoy19 described complete or partial pain relief in 97% of patients who were treated for painful metastasis (29 patients) and multiple myeloma (8 patients).

Results of a study6 on percutaneous vertebroplasty in 231 patients showed a 90% success rate in the treatment of osteoporotic vertebral fractures and an 80% success rate in painful or unstable neoplastic lesions and vertebral hemangiomas.

A Mayo Clinic study20 concluded that patients (113 patients were treated at 164 vertebral levels) who underwent vertebroplasty experienced relief of back pain and symptoms, as shown by improvement in verbal pain and RDQ (Roland-Morris Disability Questionnaire) scores. The RDQ correlates well with measures of pain, shows clinically significant improvement, and is responsive to changes across time. Prior to treatment, the average RDQ score was 18 on a scale of 23. The RDQ dropped to an average score of 11 immediately after treatment and remained at that level throughout the year-long study.

Warning/adverse events

Serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism, and cardiac embolism. Although it is rare, some adverse events have been known to occur up to one year post-operatively. Additional risks exist with the use of bone cement. Please see the IFU for a complete list of potential risks.

Procedure animations and testimonials

Dan Foley - Vertebroplasty
Dan Foley, Vertebroplasty

Testimonial from Dan Foley who suffered a spinal injury in his L1 due to a Quad Accident.

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Procedure step by step

VP-1-fracture compressed

Vertebral compression fracture is identified

VP-2-needle

Needle is guided into fractured vertebra using fluoroscopy

VP-3-cement partial

Bone cement or bioactive resin is injected

VP-4-filled

Stabilized vertebral body

Before your procedure

A doctor will do a physical exam and order x-rays and/or other imaging tests such as an MRI, CT, or bone scan. These tests help to determine the location of the fractured vertebra, how recently it occurred, and whether or not vertebroplasty is the most appropriate treatment. If the patient is pregnant, please tell the doctor before undergoing a vertebroplasty.

During your procedure

Generally, vertebroplasty is performed while you are awake but sedated. Your back is numbed by a local anesthetic. Using x-ray guidance, a needle is inserted into the fractured vertebra through a small incision. The void is filled with bone cement to stabilize the fracture. As it hardens, the cement forms an internal cast that holds the vertebra in place. The incision is covered with a bandage. 

After your procedure

After the procedure, the patient will lie on their back for a short period of time while the cement continues to harden. Vital signs will be monitored. Typically, patients are able to go home within a few hours of treatment. If the patient has any signs of wound infection, bleeding, or hematoma, they should contact their healthcare provider immediately.

1000-025-491 Rev A