Kyphoplasty

Vertebroplasty Benefits Questioned in Recent Studies

cmaynard — Wed, 12 Aug 2009 08:59:45 -0700

August 13, 2009
by: Sylvia Marten

Recent studies have questioned the minimally-invasive spine surgery [url:1064,type=|term|,content=|vertebroplasty|], specifically noting that there was no apparent benefit from the procedure as compared to a simulated treatment that mimicked a vertebroplasty but lacked one key element.

Led by researchers from the Mayo Clinic, one study compared function and pain in patients who had [url:6027,type=|node|,content=|vertebroplasty surgery|] and a placebo group who had their backs numbed but did not receive an injection of the bone cement.

More specifically:

131 patients were randomly assigned to either a vertebroplasty or the simulated procedure in eight medical centers in the United States, United Kingdom and Australia
68 patients were treated with vertebroplasty
63 patients were given the simulated treatment.

According to the study’s findings as published in the New England Journal of Medicine, there was no difference between the treatments after one month: both groups experienced significant and similar reductions in disability and pain, making it impossible to declare a better treatment, and calling into question, at least according to some, the benefit of vertebroplasty.

While one researcher noted that the study isn’t saying that vertebroplasty is ineffective, it does raise the argument of whether the improvements are actually the result of sedation, local anesthesia or other factors as opposed to the injection of bone cement.

Other Research on Vertebroplasty Supports Mayo Study

The findings of the Mayo-led study coincided with the results of a separate study by the Australian government. In this study that was also recently published in the The New England Journal of Medicine:

78 patients with 1 or 2 unhealed vertebral fractures of less than 12 months in duration participated in the multi-centered study
38 of those patients underwent vertebroplasty
40 patients were placed in the control group.

The primary outcome of overall pain (on a scale of 1-10) was measured at 1 week and 3 and 6 months. According to the findings, both groups of patients experienced significant but similar improvements in pain; in other words, once again there was no major difference establishing one of the two treatments as being more beneficial.

Update: On Thursday, October 16, 2009, the North American Spine Society (NASS) issued a response to these two randomized controlled trials. After reviewing the studies, the NASS noted how it was not looking to discredit these studies or the integrity of their authors, but was rather interested in exploring the disconnect between the findings of these two studies and previous findings on vertebroplasty. Read the NASS response below:

Newly Released Vertebroplasty RCTs: A Tale of Two Trials.

What Do These Findings Reveal about Vertebroplasty?

A lot of opinions have been formed in the week since the release of the results from these first two studies to examine the effect of vertebroplasty. Some doctors have said that these independent studies reveal that vertebroplasty is not beneficial and should be performed only in clinical research trials designed to continue studying its effectiveness.

Other doctors have raised concerns about the vertebroplasty research, including the lack of willing participants, small patient sizes and a flaw in the study that allowed patients to crossover from one treatment to the other. Others have cited the need for more research beyond two trials.

Of course, the issue is an important one for several reasons:

An estimated 100,000 vertebroplasty procedures were performed last year in the United States, according to a Wall Street Journal story. While the risks of vertebroplasty (specifically, leaking bone cement leading to soft tissue damage, nerve pain and compression, pulmonary embolism, respiratory or cardiac failure, and/or even death) are extremely small, it would make no sense to expose patients to such risks if the benefits of the surgery did not outweigh them.
With 250,000 vertebral fractures diagnosed each year, it’s vital that patients are receiving and paying for care that is actually beneficial; the same goes for doctors in terms of performing and paying for vertebroplasty. According to the Wall Street Journal story, vertebroplasty can cost anywhere from $2,000 to $5,000.
Amidst the debate on health care reform, legislators will certainly be interested in the actual benefits of vertebroplasty (which is covered by Medicare) as they go back and forth on legislation. According to a doctor at Dartmouth in a Forbes article, Medicare paid for 40,000 vertebroplasty procedures last year at a price of roughly $3,000 each.

More Information:

[url:1614,type=|node|]
[url:930,type=|node|,content=|When Is Back Pain a Fracture?|]
[url:699,type=|node|,content=|Definitive Guide to Osteoporosis Fractures|]
[url:926,type=|node|,content=|What You Need to Know about Osteoporosis|]
[url:934,type=|node|,content=|4 Proven Steps to Prevent Osteoporosis Fractures|]
[url:15644,type=|node|,content=|Conservative Treatments for Osteoporosis and Surgery for Vertebral Fractures|]

Definitive Guide to Osteoporosis

spine-health — Tue, 11 Dec 2007 21:16:20 -0800

Osteoporosis is a thinning of the bones that causes them to become porous and fragile. It affects women more than men, is associated with aging, and progresses more rapidly after menopause. The good news is that osteoporosis is largely preventable and treatable.

Locating a Doctor and Insurance Coverage for Kyphoplasty

Ben Parr — Sun, 01 Mar 2009 09:49:56 -0800

A physician answers patient questions about health insurance and kyphoplasty surgery.

Question: Denied Kyphoplasty surgery by insurance; what is the next step?

I am a 55 year old female who has comp. fractures at T7 and T8. My insurance company denied me kyphoplasty surgery, stating there has not been enough clinical data to support its success and Medicare is the only insurance to date that has paid my doctor to perform this procedure.

Kyphoplasty Surgery and Back Pain Relief

Ben Parr — Sun, 01 Mar 2009 09:49:47 -0800

A physician answers patient questions about kyphoplasty for back pain relief.

Question: Kyphoplasty for permanent pain relief

I had a laminectomy 11 years ago, which seemed successful at the time. The surgery lasted many years (6 or 7) and now pain has emerged, suspected cause is pressure at the S-I joint. I have had many years of injections into the joint with minimal short term relief.

Kyphoplasty and Vertebroplasty for Spinal Fractures

Ben Parr — Sun, 01 Mar 2009 09:48:38 -0800

A physician answers patient questions about the effectiveness of kyphoplasty and vertebroplasty.

Question: Kyphoplasty vs. Vertebroplasty?

What is the difference between kyphoplasty and vertebroplasty with respect to the time limitations on the effectiveness of the treatments from the time of the bone fracture?

Conservative Treatments for Osteoporosis and Surgery for Vertebral Fractures

Ben Parr — Fri, 19 Dec 2008 08:04:08 -0800

Preventing Spinal Fractures: Diet, Exercise, and Physical Exams

Ben Parr — Thu, 18 Dec 2008 14:37:01 -0800

More Osteoporosis Info

Osteoporosis Treatments

Spine Fractures

Kyphoplasty Surgery

Osteoporosis Medications

Eating foods rich in calcium and vitamin D and participating in weight-bearing exercises, such as walking, dancing and weight-lifting, can help slow the process of osteoporosis by keeping bones healthy.

Spine Fracture Treatment Options

Ben Parr — Wed, 17 Dec 2008 13:53:47 -0800

Treatment Options for a Spine Fracture

More Osteoporosis Info

Osteoporosis Treatments

Spine Fractures

Kyphoplasty Surgery

Osteoporosis Medications

Osteoporosis: Diagnosis and Treatment of Painful Spine Fractures

spine-health — Thu, 24 Jan 2008 13:43:45 -0800

Dr. Jeffrey Spivak discusses sudden onset of acute or severe back pain and when you should be concerned that the new pain is related to or caused by a spinal fracture. He makes recommendations about how long to wait before seeing a doctor, and what kinds of tests should be performed once you do go to your physician. In the second video, he discusses treatment options once you have been diagnosed with a spinal fracture.

Kyphoplasty

spine-health — Fri, 04 Jan 2008 07:53:04 -0800

Definition

A surgical procedure that expands and stabilizes compression fractures of the spine.

During kyphoplasty, a balloon device is introduced into the spine and inflated to expand the bone. The cavity created by the balloon is then filled with a bone cement mixture. With this process completed, an internal cast is formed inside the vertebral body with the goals of reducing pain, stabilizing a damaged area and/or restoring lost height in the vertebral body.

Kyphoplasty: Osteoporosis Fracture Treatment

spine-health — Thu, 03 Jan 2008 11:19:43 -0800

Kyphoplasty is a minimally invasive surgical procedure used for treating vertebral fractures resulting from osteoporosis. This interactive video takes you step by step through kyphoplasty spine surgery.

Vertebroplasty and Kyphoplasty: Percutaneous Injection Procedures for Vertebral Fractures

spine-health — Wed, 12 Dec 2007 00:03:20 -0800

On This Page:

Vertebroplasty

Kyphoplasty

Potential risks and complications

Other considerations

Kyphoplasty Considerations and Alternatives

spine-health — Wed, 12 Dec 2007 00:03:19 -0800

Timing of Kyphoplasty surgery

Top Back Surgery Topics:

Back/Neck Surgery Intro

Microdiscectomy

Lumbar Laminectomy

Cervical Spine Surgery

Lumbar Spinal Fusion

Kyphoplasty for Vertebral Compression Fractures

spine-health — Wed, 12 Dec 2007 00:03:19 -0800

Kyphoplasty overview
Kyphoplasty is an elective surgery designed to achieve three main goals in patients suffering from painful vertebral compression fractures:

Pain Relief After a Vertebral Compression Fracture

spine-health — Wed, 12 Dec 2007 00:03:14 -0800

Kyphoplasty for spine fractures

When a painful fracture from osteoporosis occurs in the spine, kyphoplasty is a treatment option designed to help reduce or eliminate the pain, restore height of the vertebral body and reduce spinal deformity. Vertebral compression fractures from osteoporosis are quite common, occurring in approximately twenty percent of women over the age of seventy years old.

Description of Kyphoplasty Surgery

spine-health — Wed, 12 Dec 2007 00:03:13 -0800

The goals of the kyphoplasty surgical procedure are designed to stop the pain caused by a spinal fracture, to stabilize the bone, and to restore some or all of the lost vertebral body height due to the compression fracture.

During kyphoplasty surgery, a small incision is made in the back through which the doctor places a narrow tube.
read more

Vertebral Fracture Treated with Kyphoplasty: Case Review

spine-health — Wed, 12 Dec 2007 00:03:13 -0800

The following set of images outlines one patient's experience with the use of kyphoplasty to treat a vertebral compression fracture.

Kyphoplasty for an Osteoporosis Fracture

spine-health — Wed, 12 Dec 2007 00:03:13 -0800

More Osteoporosis Info

Back Pain and Fractures

Full Osteoporosis Guide

Osteo. Fracture Prevention

Calcium and Vitamin D

Mr. WW’s Kyphoplasty Procedure

spine-health — Wed, 12 Dec 2007 00:03:13 -0800

Mr. WW had an extensive history of medical problems, including high blood pressure, severe coronary artery (heart) disease and a seizure disorder, so he was felt to be at high risk for general anesthesia and thus local anesthesia was employed during the kyphoplasty procedure as the sole pain-numbing agent.

Diagnosing Vertebral Compression Fractures

spine-health — Tue, 11 Dec 2007 21:32:53 -0800

What is Osteoporosis?

spine-health — Tue, 11 Dec 2007 21:32:53 -0800

As defined by the World Health Organization, osteoporosis is a generalized skeletal disorder of low bone mass (thinning of the bone) and deterioration in its architecture, causing susceptibility to fracture.

There are two types of osteoporosis: