FDA Approves Third Cervical Artificial Disc: the Bryan Cervical Disc from Medtronic
June 4, 2009
by: Spine-health Staff Writer
After long trials of deliberation, Medtronic’s Bryan Cervical Disc became FDA-approved on May 12, 2009. The Bryan Cervical Disc, designed to alleviate neck pain and related disability caused by degenerative disc disease, had received a favorable FDA recommendation back in July of 2007.
Although approved, conditions have been put in place for the approval of the Bryan for the next ten years. Medtronic will be conducting a post-market study, which will include tracking of patients' neck disability index scores, radiographic information, neurological status and a number of other outcomes in addition to data on adverse events and explanted devices.
What is unique about the Bryan is it is designed to better mimic natural disc shock absorption. It is made of titanium and polyurethane, which is softer than the nuclei of competitive discs, such as the Prestige’s metal on metal design. The polyurethane in the Bryan raised questions on wear debris during the FDA panel, but was determined to not be an issue for short-term use. Long-term use is an area of concern though, and will be under surveillance.
The Bryan (Medtronic), Prestige (Medtronic) and ProDisc-C (Synthes) are the only cervical artificial disc replacement options for the U.S., although there are expected to be more approvals and launches soon. At this point, Medtronic has not commented on the Bryan’s approval, or on projected launch dates when it will be commercially available.
Posted by: Spine-health Staff Writer
Additional Artificial Disc Replacement sources:
To the Point: Acupuncture for Easing Back Pain
May 29th, 2009
Some back pain sufferers go to great lengths to find relief. Although acupuncture may seem like an extreme form of treatment, it is actually fairly common and has reported high levels of success in many cases.
The Group Health Center for Health Studies in Seattle, in conjunction with Northern California Kaiser Permanente in Oakland, performed a study in which a group of 600 adults suffering from chronic lower back pain agreed to receive one of the following forms of treatment:
- Individualized acupuncture, which uses specific needling sites, number of needles and depth of insertion depending on the patient
- Standardized acupuncture, which uses 8 points found to be effective in treating low back pain
- Simulated acupuncture, which mimicked acupuncture using a toothpick
- Routine care measures, such as medication or physical therapy
The patients who underwent acupuncture treatments—including the simulated one—were more likely to report greater improvements in their ability to function than those who just received routine care.
Researchers who conducted the study concluded that the specific effects of the acupuncture and acupuncture-like treatments remain unclear. It is unknown whether the treatments provide physiologically important stimulation or represent a placebo effect.
Although the healing powers of acupuncture are not solidly proven, there are some positive effects to the body that are commonly accepted. It can help stimulate the central nervous system (brain and spinal cord) and cause specific chemicals to be released into the body that can physically and psychologically affect pain. Many people swear by this ancient Chinese method of medicine and it could be an alternative care option to look into if you are not finding relief through other methods.
Posted by: Sylvia Marten
Additional Acupuncture and Alternative Care treatment sources:
Non-Medical Care Alternatives for Back Pain
Yoga, Pilates, and Tai Chi Health Center
Massage Therapy for Lower Back Pain
The Group Health Center for Health Studies Acupuncture StudyOsteoporosis Fractures Increase Risk of Death, Study Shows
May 21, 2009
by: Sylvia Marten
A recent study reported that older men and women who suffer a low-trauma fracture due to osteoporosis are at increased risk of dying for 5 to 10 years following the injury, compared to the general population. Those who experience another fracture increase their risk of death for an additional 5 years.
Osteoporosis-related fractures are a growing health concern, especially with the aging of the U.S. population. Principal investigator Dr. Jacqueline R. Center states that all low-trauma fractures, not just hip fractures, are significant events that need to be addressed as such. At the very least, osteoporosis treatment (for low bone density) should be instituted following any injury to decrease the risk of a subsequent fracture.
In the study, conducted at the Garvan Institute of Medical Research in Sydney, researchers examined the long-term risk of death following osteoporotic fractures in 2,245 women and 1,760 men aged 60 and older. Among the women, there were 952 low-trauma fractures followed by 461 deaths, while among the men, there were 343 fractures followed by 197 deaths.
Researchers concluded that compared to the general population, patients were at an increased risk of death following a hip fracture, a spine fracture, and other major fractures for 5 years post-fracture. Minor fractures only showed an increased risk of death in those aged 75 and older. After 5 years, the risk of death decreased, except for hip fractures, with which the risk remained for 10 years. After 10 years, death rates were not different from that of an appropriately age-matched population.
Perhaps the most important result of the study was the finding that nonhip and nonvertebral fractures not only constituted 50% of the fractures, but that they were also associated with 29% of the premature mortality, suggesting that more attention should be given to these types of fractures.
Several factors are believed to increase the risk of death following a fracture, including weaker quadriceps in both men and women, lower bone density, increased sway and having smoked in women, and decreased physical activity in men. The specific circumstances surrounding the fracture also must be considered to appropriately assess any existing risk factors for osteoporosis.
Posted by: Sylvia Marten
Additional Osteoporosis and Fracture resources:
Exercise Ball Exercises: Exercise Balls Relieve Back Pain
April 22, 2009
by: Stephanie
Exercise ball exercises are extremely effective for individuals looking to strengthen their core muscles and have steadily become one of the most popular and effective exercise routines for accomplishing this. People have even brought these fitness balls into the office to help promote good posture and get a workout while sitting at their desks. This alternative to standard office chairs is becoming more and more commonplace and the people who are using them report having less back pain and a stronger core.
On Thursday, April 16, one of the industries largest exercise ball manufacturers, EB Brands, has voluntarily recalled over 3 million exercise balls that were made in China.
Initial reports claim that EB Brands received several complaints of these exercise balls popping under pressure, although the products specifically say they are burst-resistant on the packaging.
Bally Total Fitness, Everlast, Valeo and Body Fit Fitness Balls, all made by EB Brands, are involved in the recall. I say recall tentatively because EB Brands is not removing these exercise balls from stores nor will they be taking the balls back unless they burst. Regardless, numerous people have gotten substantially injured when such bursts have taken place including women that are pregnant and children to name a few. Injuries have ranged from minor bruises and cuts to serious concussions and even fractures. What's more is people who previously lived and died by their fitness balls are now questioning whether they want to chance getting hurt themselves.
"I can just imagine being in Pilates class and having the ball explode on you," said Nancy Cowles, who has a fitness ball at home.
That truly is a scary notion and definitely something that shouldn't be taken lightly, especially when these fitness balls are big, bright, and colorful - very tempting for children to jump and play on.
Although millions of exercise balls have been recalled, this does not mean that exercise balls are ineffective in treating lower back pain and in strengthening the core. In fact, many people will argue that there is not a better core workout available than the fitness ball. If you are thinking about trying out a fitness ball to alleviate back pain I recommend you still give it a shot - just make sure you follow the instructions that come with the exercise ball.
Bursting Exercise Balls: Tips for Staying Safe
If you use an exercise ball involved in the recall, read the instructions carefully and contact the company before further use.
For more information, call the EB Brands hotline at (800) 624-5671 or visit their Web site at www.ebbrands.com.
Good luck with your decision and your recovery!
Posted by: Stephanie
More resources:
- Strengthening Exercises to Build Muscle Support
- Rehabilitation and Exercise for a Healthy Back
- Manual Physical Therapy for Pain Relief
- How to Start an Exercise Ball Program
- Exercise and Back Pain
- Choosing the Right Exercise Ball
- Easy Exercise Program for Low Back Pain Relief
Visit ABC News for the full article.
Spinal Fusion Surgery Worth the Cost for Stenosis Patients?
March 25, 2007
by: Spine-health Staff Writer
Back pain affects more than 80% of people in the U.S. at a cost of more than $100 billion a year. While many conditions can be treated conservatively (non-surgically), sometimes surgery is the only way to provide considerable relief. The question becomes whether or not the high cost of spine surgery is worth it.
A recent study conducted at Rush University Medical Center in Chicago suggests that for patients with spinal stenosis, a laminectomy, or surgical removal of pain-causing soft bone and tissue, is a reasonable value. However, for patients with spinal stenosis who have associated slipped vertebrae, the benefits of spinal fusion surgery may not be worth the costs.
Rush was one of 13 sites across the country that followed patients in this Spine Patient Outcomes Research Trial (SPORT). This study is significant, as it is the first to systematically track health care expenditures along with health outcomes. With more than 650,000 spinal surgical procedures being formed annually in the U.S. at costs exceeding $20 billion, the value of this investment is an important consideration.
The study consisted of 3,900 patients with one of two conditions: spinal stenosis treated with laminectomy, and spinal stenosis with associated slipped vertebrae, treated with spine fusion surgery. The patients were divided into groups of non-surgical vs. surgical treatments; of the surgical patients, 320 underwent laminectomy and 344 had spinal fusion.
Researchers used the Quality Adjusted Life Year (QALY) scale to perform a cost/benefit analysis over a two-year post-surgery period. Laminectomy was calculated to cost $77,000 per QALY gained, while spinal fusion surgery was estimated to be $115,000 per QALY gained. In the United States, $100,000 is the maximum at which procedures are considered cost effective.
While the initial analysis indicates that laminectomy offers better value than spine fusion surgery, a definitive assessment of long-term cost effectiveness is still in the works. Cost effectiveness is an important consideration in providing patients with quality care, but the bottom line is that for many patients suffering from back pain, relief is worth any cost.
The study is published in the December 16 issue of the Annals of Internal Medicine.
By: Spine-health staff writer
Sources:
Surgical Treatment of Spinal Stenosis with and without Degenerative Spondylolisthesis: Cost-Effectiveness after 2 Years
http://www.annals.org/cgi/content/abstract/149/12/845
Additional Reading:
Spinal Fusion for Synovial Cyst and Spinal Stenosis
About the Bloggers
The Spine-health Blog is an educational and editorial tool authored and maintained by Spine-health staff. Unlike most Spine-health articles, this area is not peer-reviewed. Specific questions concerning your health should always be discussed with your doctor.
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Peter Ullrich, Jr., MD
Doctor Ullrich is an orthopedic spine surgeon at the NeuroSpine Center of Wisconsin and co-founder and Medical Director for Spine-health.com.
He started Spine-health.com based on the belief that patients deserve the same quality of medical information as physicians – that is, information that has been independently peer reviewed by other physicians to ensure accuracy, completeness, and lack of any commercial influence.
In addition to his peer-reviewed back pain articles, Dr. Ullrich blogs about personal opinions and issues regarding spine surgery and spine medicine. Read more about Dr. Ullrich at his practice page.
Stephanie Burke
The CEO and co-founder of Spine-health, Stephanie shares the goal of providing intelligent, unbiased and highly relevant medical information and community support for people dealing with a wide range of pain conditions and related issues, including back pain, arthritis, fibromyalgia, depression, osteoporosis, sleep disorders, exercise, diet and more.
She blogs about special interest stories, and pays special attention to information sent in from the thousands of people visiting Spine-health.com each day, all in the hope that full information will help individuals make better choices. Contact Stephanie at Sburke at spine-health.com.
Sylvia Marten
Sylvia Marten is the President of Spine-health, and oversees the day-to-day operations of the business, including sales and marketing. Sylvia leverages 14 years of experience in online health, sales and business development, marketing, and strategic consulting to create successful experiences between Spine-health’s unique back pain consumers/patients and physicians - and the companies that wish to market to them.
Sylvia will occasionally blog about news relevant to back pain sufferers, tips and ideas for managing pain, trends and events in the pain market, health online media and marketing. Contact Sylvia at Smarten at spine-health.com.
