Studies Unclear Whether Spinal Cement Procedure Improves Back Pain

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Studies Unclear Whether Spinal Cement Procedure Improves Back Pain

http://www.medicalnewstoday.com/medicalnews.php?newsid=43415

A procedure that fills in fractured vertebrae with injected cement

has not been shown to improve a person's back pain or quality of

life, according to a new analysis of studies.

The procedure, known as percutaneous kyphoplasty, does seem to expand

areas of collapsed backbone and restore some vertebral height in

patients with osteoporosis, although the studies did not offer enough

information to precisely measure the magnitude of these improvements,

the researchers found.

The lack of studies directly comparing kyphoplasty to more simple

treatments such as bed rest " prevented us from being able to

determine whether percutaneous kyphoplasty improves patients' pain,

functional ability or quality life, " the review authors conclude.

The review is published by ECRI, a nonprofit health services research

agency that produces technology assessments on medical devices,

drugs, biotechnologies and procedures.

A surgeon performing percutaneous kyphoplasty inserts a balloon into

a patient's fractured vertebrae, inflates the balloon and fills the

space created by the balloon with bone cement. A similar procedure

called vertebroplasty injects bone cement directly into the

vertebrae.

" The aim of vertebroplasty is to stabilize the fractured vertebral

body, while the goals of kyphoplasty are to stabilize the vertebral

body and to restore its height to as near its prefracture level as

possible, " said Gladius , Ph.D., a biomechanics and biomaterials

research at the University of Memphis.

The goal of both procedures is to strengthen crushed or compressed

vertebral bone in people with osteoporosis and multiple myeloma

patients who suffer from severe bone tumors.

" In principle, such treatment may prevent further fracture or

collapse of the bone, " the ECRI authors say.

Compression fractures in the porous bone of the spine can cause pain

and reduce mobility, and may lead to a stooped posture that squeezes

the chest cavity and interferes with lung function.

In the United States, 15 percent of women and 5 percent of men will

probably have at least one such fracture in their lifetimes, although

they often go unnoticed because people attribute the pain to

arthritis or simply old age, the ECRI authors say.

Kyphoplasty is only recommended for people who still have pain and

reduced mobility after trying more conservative treatments such as

bed rest, anti-inflammatory medicines and physical therapy.

Kyphoplasty is not recommended for certain severe fractures and

spinal infections.

The ECRI review looked at 16 studies of percutaneous kyphoplasty,

mostly in osteoporosis patients. The procedure was performed in both

the lumbar (lower back) and thoracic (middle back) vertebrae.

" To the best of our knowledge, we don't believe there is any evidence

out there that would suggest kyphoplasty is more effective when used

on lumbar or thoracic vertebrae, " said Dr. Tregear, director

of special projects for ECRI.

None of the patients in the 16 studies died as a result of

kyphoplasty. Leaking bone cement was the most common side effect of

the treatment, occurring in up to 34 percent of vertebrae. Although

leakage is common, it rarely causes problems for patients, Tregear

says.

Although there has been a lot of research on injectable bone cements,

few critical reviews compare different types of cement and their

properties, said. Different cement fillers were not compared in

the ECRI study, Tregear said.

The U.S. Food and Drug Administration issued a warning about serious

complications related to the use of bone cement and bone-void fillers

in treating compression fractures of the spine and has extended the

warning to apply to all types of bone cement and bone-void fillers

that are not specifically cleared and labeled for kyphoplasty.

According to the ECRI study authors, kyphoplasty costs $3,400 to

$4,000 for the kyphoplasty materials and $8,000 to $10,000 in doctor

and hospital fees. Health insurance carriers vary in their coverage

of the procedure, and the Centers for Medicare and Medicaid Services

have not set a national coverage standard for kyphoplasty.