We Specialize in Kyphoplasty
A minimally invasive surgery used to treat a spinal compression fracture.
Osteoporotic Vertebral Body Compression Fractures are severely painful and debilitating fractures that significantly interfere with an individuals health, well being, and quality of life. Medicare claims data show an 85 percent 10-year mortality rate following a diagnosis of vertebral body compression fractures. The good news is that Dr. Manoogian is a Fellowship Trained Spine Surgeon, who has been successfully treating patients with these fractures with Kyphoplasty, since the inception of his practice over 20 years ago. Medicare claims data show a significant decrease in mortality and an increase in positive clinical outcomes among patients who receive vertebral argumentation (kyphoplasty) procedures over patients who receive non-surgical management of Vertebral Body Compression Fractures.
Could I Be At Risk For a Spinal Fracture?
Spinal fractures, also known as vertebral compression fractures (VCFs), are the most common fracture caused by osteoporosis. As many as two-thirds of spinal fractures go undiagnosed and untreated because patients are not aware of the symptoms, so it is important to be aware of your risk for a spinal fracture and to see your doctor right away if you think you may have one.Check how much you know about spinal fractures:
Facts About Spinal Fracture1,2
- Osteoporosis is responsible for over 700,000 spinal fractures each year in the U.S.
- One in four women over age 50 will suffer an osteoporosis-related spinal fracture
- Unlike the pain from a broken arm or hip, the pain from a spinal fracture can be mild, making it difficult to know you have a broken bone in the spine
- Left untreated, multiple fractures can cause a hunched back (kyphosis) and affect your overall health
Risk Factors and Symptoms1,2
- Over age 50 or postmenopausal women
- Osteoporosis, low bone mineral density, or prior fractures after age 50
- Family history of osteoporosis, fractures, or a hunched back
- Height loss or a hunched back
- Sudden onset of back pain lasting more than a few days (even if pain is only mild)
If You Think You Have a Spinal Fracture
- See your doctor as soon as possible for diagnosis and treatment
- Ask your doctor if you should have a spine X-ray or MRI
- If necessary, get a referral to a spine specialist for treatment – caught early, spinal fractures can be repaired
Treating Spinal Fractures with Balloon Kyphoplasty
- A minimally invasive procedure designed to repair spinal fractures
- Corrects the spinal deformity caused by the fracture
- Significantly reduces back pain
- Assists return to usual day-to-day activities
- Increases strength, mobility and independence
Although the complication rate with Kyphon™ Balloon Kyphoplasty has been demonstrated to be low, as with most surgical procedures, there are risks associated with the procedure, including serious complications. Consult with your doctor for a full discussion of risks.
1. National Osteoporosis Foundation. www.nof.org/osteoporosis/diseasefacts.htm. Accessed August 31, 2007.
2. Gold DT, Silverman SL. The Downward Spiral of Vertebral Osteoporosis: Consequences. Monograph sponsored by Cedars-Sinai Medical Center, Los Angeles. RemedicaCommunications, Inc., June 2003.
- Osteoporosis is estimated to affect 200 million women worldwide.1
- Worldwide, osteoporosis causes more than nine million fractures annually, resulting in an osteoporotic fracture every three seconds.1
- A recent report issued by the Surgeon General noted that by 2020, one in two Americans over age 50 will be at risk for fractures from osteoporosis and low bone mass.2
- Although prevalent, 75 percent of women and 90 percent of men with a high likelihood of developing osteoporosis are not investigated.3
- Up to 80 percent who have already had at least one osteoporotic fracture are neither identified nor treated.3
- Overall, 61 percent of osteoporotic fractures occur in women, with a female-to-male ratio of 1.6.4
- A prior fracture is associated with an 86 percent increased risk of any fracture.5
- In 2005, osteoporosis-related fractures cost the U.S. health care system about $17 billion per year.6
- Osteoporosis takes a huge personal and economic toll. In Europe, the disability due to osteoporosis is greater than that caused by cancers (with the exception of lung cancer) and is comparable to or greater than that lost to a variety of chronic noncommunicable diseases, such as rheumatoid arthritis, osteoarthritis, chronic obstructive pulmonary disease (COPD) and ischemic heart disease.4
About Vertebral Compression (Spinal) Fractures
- Osteoporosis causes more than 700,000 spinal fractures each year in the U.S. – more than twice the annual number of hip fractures1 – accounting for more than 100,000 hospital admissions and resulting in close to $1.5 billion in annual costs.8
- Vertebral fractures are the most common osteoporotic fracture, yet approximately two-thirds are undiagnosed and untreated.1
- Approximately 20 to 25 percent of Caucasian women and men over 50 years old have a prevalent vertebral fracture.1
- One in five women with a vertebral fracture will sustain another within 12 months.1
- Vertebral fractures lead to severe spinal deformity, back pain, loss of height, reduced mobility, depression and increased number of bed days.1
- The impact vertebral fractures have on quality of life can be profound, as a result of loss of self-esteem, isolation and depression. Vertebral fractures also significantly impact activities of daily living.1
- Vertebral fractures are associated with a 20 percent reduction in QALY (quality adjusted life year) in the first 12 months, and a 15 percent reduction in the first two years since time of fracture.9
1. Bouxsein , M. L., & Genant, H. K. (2010). The Breaking Spine. International Osteoporosis Foundation.
2. U.S. Department of Health and Human Services (2004). “=By 2020, One In Two Americans Over Age 50 Will Be At Risk For Fractures From Osteoporosis Or Low Bone Mass. U.S. Department of Health and Human Services, Office of the Surgeon General. Retrieved from http://archive.hhs.gov/news/press/2004pres/20041014.html
3. Nguyen, et al (2004). Osteoporosis: Underrated, Underdiagnosed and Undertreated. The Medical Journal of Australia. 2004; 180: S18-22.
4. Johnell O and Kanis JA (2006) An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporosis International 17:1726.
5. Kanis, et al (2004). A Meta-Analysis of Previous Fracture and Subsequent Fracture Risk. Bone. 2004; 35: 375-382.
6. Clinician’s Guide to Prevention and Treatment of Osteoporosis (January, 2010.) National Osteoporosis Foundation.
7. Kanis, et al (1997). Guidelines for Diagnosis and Management of Osteoporosis. Osteoporosis International: 1997; 7: 390-406.
8. Cooper, et al. Nonoperative Treatment of Osteoporotic Compression Fractures Overview of Osteoporotic Compression Fractures (March 29, 2011.) Medscape. Retrieved from http://emedicine.medscape.com/article/325872-overview
9. Tosteson, et al. (2001). Impact of Hip and Vertebral Fractures on Quality-Adjusted Life Years. Osteoporosis International. 2001; 12: 1042-1049
Kyphon™ Balloon Kyphoplasty for Vertebral Compression Fractures (VCF) BACKGROUNDER
The Condition: Spinal Fractures
Osteoporosis is the most widespread degenerative disease in the developed world. Globally, an osteoporotic fracture is estimated to occur every three seconds with spinal fractures being the most common.1
Osteoporosis causes more than 700,000 spinal fractures each year in the U.S., more than twice the annual number of hip fractures.2,3
Spinal fractures can also be caused by cancer, the most common forms being multiple myeloma, breast, lung and prostate.4According to the Multiple Myeloma Research Foundation, the majority of patients with multiple myeloma—some 70 to 95 percent—experience progressive bone destruction, particularly in the spine, because rapidly growing myeloma cells push normal bone-forming cells aside.
Although spinal osteoporotic fractures are the most common type of fragility fracture, they remain largely undiagnosed and untreated. Up to two-thirds are not recognized by doctors.3 Untreated, as many as one in five women with a spinal fracture will sustain another within 12 months, often referred to as the “fracture cascade.” Just 40 percent of older women and less than 20 percent of men with spinal fractures visible on X-ray are tested for osteoporosis.3
Some spinal fractures may collapse immediately while others collapse over time, resulting in a condition called kyphosis, or rounded back. Kyphosis, signified by the so-called dowager’s hump, compresses the chest and abdominal cavity, which can result in serious negative health and quality of life (QOL) consequences such as:
- Increased risk of falls and fractures3
- Increased patient disability3
- Height loss3
- Chronic and acute pain3
Quality of Life Consequences
- Reduced mobility including slower walking pace and use of walking aids3
- Loss of self-esteem3
- Social isolation3
The current standard of care for a spine fracture is bed rest, pain medication, physical therapy, bracing and local steroid injections.2 However, this approach does little to treat or prevent the formation of a kyphosis deformity and the associated “downward spiral” of negative consequences.
Balloon Kyphoplasty Outcomes
Balloon Kyphoplasty is a minimally invasive treatment that corrects vertebral deformity and stabilizes VCFs, thereby providing pain relief.
- Vertebral Height Restoration
- Significant improvement in quality of life3
- Significant improvement in mobility, including the ability to perform daily activities such as walking, hobbies and work7
- Low complication rate (<1%)7
- Reduction in back pain3
- Vertebral Height Restoration
- Maintenance of improvement in quality of life3
- Maintenance of improvement in mobility, including the ability to perform daily activities such as walking, hobbies and work7
- Maintenance of reduction in back pain3
Restoring normal spine anatomy can help a patient avoid the negative health and QOL consequences of a rounded back.
The Balloon Kyphoplasty Procedure
Through a pair of small incisions each approximately 1 cm in length, the specialty physician uses a needle and cannula to create a small pathway into each side of a fractured vertebralbody. A small balloon is guided through each cannula into the vertebra. Each balloon is carefully inflated in an attempt to raise the collapsed vertebra and return it to its normal position. Inflation of the balloon creates a void (cavity) in the vertebral body.
Once the vertebra is in the correct position, the balloons are deflated and removed. The resultant cavities are filled with bone cement forming an “internal cast” to support the surrounding bone and prevent further collapse.
The Balloon Kyphoplasty procedure typically takes about one hour per fracture and may be performed in an outpatient setting. The procedure can be done using either local or generalanesthesia; the specialty physician will determine the most appropriate method, based on the patient’s overall condition. In most cases, Medicare provides coverage for Balloon Kyphoplasty. Other insurance plans often also cover the procedure.
Although the complication rate with Kyphon™ BalloonKyphoplasty has been demonstrated to be low, as with most surgical procedures, there are risks associated with the procedure, including serious complications. This procedure is not for everyone. A prescription is required. Patients should consult their physician for a full discussion of risks and whether this procedure is right for them.
1. Osteoporosis (n.d.) International Osteoporosis Foundation. Retrieved from http://www.iofbonehealth.org/osteoporosis
2. Fast Facts (n.d.) National Osteoporosis Foundation. Retrieved from http://www.nof.org/node/40
3. Bouxsein , M. L., & Genant, H. K. (2010). The Breaking Spine. International Osteoporosis Foundation. Retrieved August 24, 2012, from http://testsite.iofbonehealth.org/docs/publications/the-breakingspine.html
4. Berenson, et al (2011). Balloon Kyphoplasty versus Non-Surgical Fracture Management for Treatment of Painful Vertebral Body Compression Fractures in Patients with Cancer: A Multicentre, Randomised Controlled Trial. The Lancet Oncology: 2011; 12: 225-235; DOI: 10.1016/S1470-2045(11)70008-0.
5. Patients Starting Treatment: Living While Undergoing Treatment (n.d.) Multiple Myeloma Research Foundation. Retrieved from http://www.themmrf.org/living-with-multiple-myeloma/patients-starting-treatment/symptoms-and-side-effects/surgery.html
6. Wardlaw, et al (2009). Efficacy and Safety of Balloon Kyphoplasty Compared with Non-Surgical Care for Vertebral Compression Fracture (FREE) a Randomised Controlled Trial. The Lancet 2009; 373: 1016-1024; DOI: 10.1016/S0140-6736(09)60010-6.
7. Boonen et al (2011). Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. Journal for Bone and Mineral Research, 26: 1627–1637. doi:10.1002/jbmr.364