Percutaneous vertebroplasty by Dr.BBT

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Percutaneous vertebroplasty

Vertebroplasty and kyphoplasty are similarmedical spinal procedure

where bone cement is injected through a small hole in the skin

(percutaneously) into a fractured vertebra with the goal of relieving thepain ofvertebral compression fractures (VCF). Vertebroplasty was found

to be ineffective in treating compression fracture of the spine by each of

the only two randomized trials done to study the procedure that used a

sham procedure for the control group.

History

Vertebroplasty had been performed as an open procedure for many

decades to secure pedicle screws and fill tumorous voids. However, the

results were not always worth the risk involved with an open procedure,which was the reason for the development ofpercutaneous

vertebroplasty.

The first percutaneous vertebroplasty was performed in 1984 at the

University Hospital of Amiens, France to fill a vertebral void left after the

removal of a benign spinal tumor. A report of this and 6 other patients

was published in 1987 and it was introduced in the United States in the

early 1990s. Initially, the treatment was used primarily for tumors in

Europe and VCF in the United States, although the distinction has largelygone away since then.

Effectiveness

The effectiveness of vertebroplasty is controversial. Two randomized and

blinded trials found no benefit however they have been faulted for not

looking at people with acute vertebral fractures. Some have suggested

that this procedure only be done in those with fractures less than 6 weeks

old (which was not the population of these two trials).

NEJM Articles

Two studies published in The New England Journal of Medicine in 2009

found no benefit to vertebroplasty for compression fractures when

compared to a sham procedure :

In a multicenter, prospective double-blinded randomized controlled

trial (RCT) involving 131 participants who were patients with one or

two painful osteoporotic vertebral fractures, vertebroplasty did notresult in greater improvement than a sham procedure in overall pain,
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physical functioning, or quality of life at 3 or 6 months after

treatment. Jeffrey Jarvikof the University of Washington said his

study, funded by theNational Institutes of Health, found

vertebroplasty had no detectable benefit when compared with

procedures that only mimicked such procedures. He advises that"vertebroplasty should not be done any longer, unless it's in the setting

of a study."

In a multicenter, randomized, double-blind, placebo-controlled trial

involving 78 participants with osteoporotic vertebral compression

fractures, patients who underwent vertebroplasty had improvements

in pain and disability measures that were similar to those in patients

who underwent a sham procedure. University of Virginia radiologist

Avery Evans said his study, which was funded by the Australian

government and Cook Medical Inc., found vertebroplasty and sham

procedures offered patients nearly identical pain relief.

Several case reports and unblinded studies initially suggested that

vertebroplasty provided effective relief of pain. However, none of these

studies were comparisons to a placebo.

Nevertheless, many vertebroplasty practitioners and healthcare

professional organizations continue to advocate for the procedure.

Medicare response to NEJM articles

In response to the NEJM articles and a medical record review showing

misuse of vertebroplasty and kyphoplasty, US Medicarecontractor

Noridian Administrative Services (NAS) conducted a literature review

and formed a policy regarding reimbursement of the procedures. NAS

states that in order to be reimbursable, a procedure must meet a certain

criteria, including, 1) a detailed and extensively documented medical

record showing pain caused by a fracture, 2) radiographic confirmation of

a fracture, 3) that other treatment plans were attempted for a reasonable

amount of time, 4) that the procedure is not performed in the emergency

department, and 5) that at least 1 year of follow-up is planned for, among

others. The policy, as referenced, applies only to the region covered by

Noridian and not all of Medicare's coverage area. It became effective on

20 June 2011 and remains current.

VERTOS II Study

An unblinded study published in 2010 compared vertebroplasty toconservative care with 202 patients. The results were consistent with
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prior unblinded studies; patients who, knowingly, underwent

vertebroplasty reported improvement in pain.

Procedure

Vertebroplasty is typically performed by a spine surgeon orinterventional

radiologist. It is a minimally invasive procedure and patients usually go

home the same or next day as the procedure. Patients are given local

anesthesia and light sedation for the procedure, though it can be

performed using only local anesthetic for patients with medical problems

who cannot tolerate sedatives well.

During the procedure, bone cement is injected with a biopsy needle into

the collapsed or fractured vertebra. The needle is placed with

fluoroscopic x-ray guidance. The cement (most commonly PMMA,although more modern cements are used as well) quickly hardens and

forms a support structure within the vertebra that provide stabilization

and strength. The needle makes a small puncture in the patient's skin that

is easily covered with a small bandage after the procedure.

Kyphoplasty

Cement in a vertebra as seen on plain Xray.

Kyphoplasty is a variation of a vertebroplasty that attempts to stop the

pain caused by thebone fracture and attempts to restore the height and

angle ofkyphosis of a fractured vertebra (of certain types), followed by

its stabilization using injected bone cement. The procedure typically

includes the use of a small balloon that is inflated in the vertebral body tocreate a void within the cancellous bone prior to cement delivery. Once
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the void is created, the procedure continues in a similar manner as a

vertebroplasty, but the bone cement is typically delivered directly into the

newly created void.

In its review of vertebroplasty and vertebral augmentation procedures,Medicare contractor NAS determined that there is no difference between

vertebroplasty and kyphoplasty, stating, "No clear evidence demonstrates

that one procedure is different from another in terms of short- or long-

term efficacy, complications, mortality or any other parameter useful for

differentiating coverage."

Effectiveness

Several unblinded clinical studies have suggested a benefit of balloon

kyphoplasty for patients with spinal fractures. Earlier unblinded studiesalso suggested a similar benefit to the closely related procedure

vertebroplasty, however the only two blinded randomized controlled

studies done to assess vertebroplasty failed to demonstrate any benefit as

compared to patients who received a sham procedure. Although no

blinded studies have been performed on kyphoplasty, since the procedure

is a derivative of vertebroplasty, the unsuccessful results of these blinded

studies have cast doubt upon the benefit of kyphoplasty despite the

continued benefit suggested by unblinded studies.

Risks

A CT image of cement used in kyphoplasty that has entered the spinal

channel and is pressing on the spinal cord resulting in neurological

symptoms

Some of the associated risks that can be produced are from the leak of

acrylic cement outside of the vertebral body. Although severe

complications are extremely rare, it is important to know that infection,bleeding, numbness, tingling, headache, and paralysis may ensue due to
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misplacement of the needle or cement. This particular risk is decreased by

the use of x-ray or other radiological imaging to ensure proper placement

of the cement.

Percutaneous vertebroplasty by Dr.BBT

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