Vertebral augmentation, including vertebroplasty and kyphoplasty, refers to similar
percutaneous {{More citations needed, date=January 2021
In surgery, a percutaneous procedurei.e. Granger et al., 2012 is any medical procedure or method where access to inner organs or other tissue is done via needle-puncture of the skin, rather than by using ...
spinal procedures in which
bone cement
Bone cements have been used very successfully to anchor artificial joints (hip joints, knee joints, shoulder and elbow joints) for more than half a century. Artificial joints (referred to as prostheses) are anchored with bone cement. The bone ce ...
is injected through a small hole in the skin into a fractured
vertebra
The spinal column, a defining synapomorphy shared by nearly all vertebrates, Hagfish are believed to have secondarily lost their spinal column is a moderately flexible series of vertebrae (singular vertebra), each constituting a characteristi ...
in order to relieve
back pain
Back pain is pain felt in the back. It may be classified as neck pain (cervical), middle back pain (thoracic), lower back pain (lumbar) or coccydynia (tailbone or sacral pain) based on the segment affected. The lumbar area is the most common ...
caused by a vertebral
compression fracture
A compression fracture is a collapse of a vertebra. It may be due to trauma or due to a weakening of the vertebra (compare with burst fracture). This weakening is seen in patients with osteoporosis or osteogenesis imperfecta, lytic lesions from ...
. After decades of
medical research into the efficacy and safety of vertebral augmentation, there is still a lack of consensus regarding certain aspects of vertebroplasty and kyphoplasty.
Procedure
Vertebroplasty
Vertebral augmentation, including vertebroplasty and kyphoplasty, refers to similar percutaneous spinal procedures in which bone cement is injected through a small hole in the skin into a fractured vertebra in order to relieve back pain cause ...
and
kyphoplasty
Vertebral augmentation, including vertebroplasty and kyphoplasty, refers to similar percutaneous spinal procedures in which bone cement is injected through a small hole in the skin into a fractured vertebra in order to relieve back pain caused ...
are the two most common procedures for spinal augmentation. These
medical terms
Medical terminology is a language used to precisely describe the human body including all its components, processes, conditions affecting it, and procedures performed upon it. Medical terminology is used in the field of medicine
Medical terminolog ...
are
classical compound
Neoclassical compounds are compound words composed from combining forms (which act as affixes or stems) derived from classical Latin or ancient Greek roots. New Latin comprises many such words and is a substantial component of the technical an ...
s of the suffix ''
-plasty'' meaning "molding or shaping surgically" (from
Ancient Greek
Ancient Greek includes the forms of the Greek language used in ancient Greece and the ancient world from around 1500 BC to 300 BC. It is often roughly divided into the following periods: Mycenaean Greek (), Dark Ages (), the Archaic p ...
''
plastós'' "molded, formed") and the prefixes ''
vertebro-'' "vertebra" (from
Latin
Latin (, or , ) is a classical language belonging to the Italic branch of the Indo-European languages. Latin was originally a dialect spoken in the lower Tiber area (then known as Latium) around present-day Rome, but through the power of the ...
''
''vertebra'' "joint, joint of the spine") and ''kypho-'' "humped; stooping forward" (from Ancient Greek ''
kyphos'' "crooked").
Vertebroplasty
Vertebroplasty is typically performed by a spine surgeon or
interventional radiologist
Interventional radiology (IR) is a medical specialty that performs various minimally-invasive procedures using medical imaging guidance, such as x-ray fluoroscopy, computed tomography, magnetic resonance imaging, or ultrasound. IR performs bo ...
. 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
poly methyl methacrylate
Poly(methyl methacrylate) (PMMA) belongs to a group of materials called engineering plastics. It is a transparent thermoplastic. PMMA is also known as acrylic, acrylic glass, as well as by the trade names and brands Crylux, Plexiglas, Acrylite ...
(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.
[Nicole Berardoni M.D, Paul Lynch M.D, and Tory McJunkin M.D. "Vertebroplasty and Kyphoplasty" 2008. Accessed 7 Aug 2009. http://www.arizonapain.com/Vertebroplasty-W.html]
Kyphoplasty
![VertcementX](https://upload.wikimedia.org/wikipedia/commons/8/84/VertcementX.png)
Kyphoplasty is a variation of a vertebroplasty which attempts to restore the height and angle of
kyphosis
Kyphosis is an abnormally excessive convex curvature of the spine as it occurs in the thoracic and sacral regions. Abnormal inward concave ''lordotic'' curving of the cervical and lumbar regions of the spine is called lordosis. It can result ...
of a fractured
vertebra
The spinal column, a defining synapomorphy shared by nearly all vertebrates, Hagfish are believed to have secondarily lost their spinal column is a moderately flexible series of vertebrae (singular vertebra), each constituting a characteristi ...
(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 to create a void within the cancellous bone prior to cement delivery. Once 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 a 2011 review 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
As of 2019, the effectiveness of vertebroplasty is not supported.
A 2018 Cochrane review found no role for vertebroplasty for the treatment of acute or sub-acute osteoporotic vertebral fractures. The subjects in these trials had primarily non-acute fractures and prior to the release of the results they were considered the most ideal people to receive the procedure. After trial results were released vertebroplasty advocates pointed out that people with acute
vertebral fracture
A spinal fracture, also called a vertebral fracture or a broken back, is a fracture affecting the vertebrae of the spinal column. Most types of spinal fracture confer a significant risk of spinal cord injury. After the immediate trauma, there i ...
s were not investigated.
A number of non-blinded trials suggested effectiveness, but the lack of blinding limits what can be concluded from the results and some have been criticized because of being funded by the manufacturer.
[ One analysis has attributed the difference to selection bias.
Some have suggested that this procedure only be done in those with fractures less than 8 weeks old; however, analysis of the two blinded trials appear not to support the procedure even in this acute subgroup. Others consider the procedure only appropriate for those with other health problems making rest possibly detrimental, those with metastatic ]cancer
Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal b ...
as the cause of the spine fracture, or those who do not improve with conservative management.
Evidence does not support a benefit of kyphoplasty over vertebroplasty with respect to pain, but the procedures may differ in restoring lost vertebral height, and in safety issues like cement extravasation
__NOTOC__
Extravasation is the leakage of a fluid out of its container into the surrounding area, especially blood or blood cells from vessels. In the case of inflammation, it refers to the movement of white blood cells from the capillaries to th ...
(leakage). As with vertebroplasty, several unblinded studies have suggested a benefit from balloon kyphoplasty. , no blinded studies have been performed, and since the procedure is a derivative of vertebroplasty, the unsuccessful results of these blinded studies have cast doubt upon the benefit of kyphoplasty generally.
Some vertebroplasty practitioners and some health care professional organizations continue to advocate for the procedure. In 2010, the Board of Directors of the American Academy of Orthopaedic Surgeons released a statement recommending strongly against use of vertebroplasty for osteoporotic spinal compression fractures, while the Australian Medical Services Advisory Committee considers both vertebroplasty and kyphoplasty only to be appropriate in those who have failed to improve after a trial of conservative treatment,[ with conservative treatment (analgesics primarily) being effective in two-thirds of people.] The National Institute for Health and Care Excellence
The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body of the Department of Health and Social Care in England that publishes guidelines in four areas:
* the use of health technologies withi ...
similarly states that the procedure in those with osteoporotic fractures is only recommended as an option if there is severe ongoing pain from a recent fracture even with optimal pain management.
Vertebral body stenting
Vertebral augmentation, including vertebroplasty and kyphoplasty, refers to similar percutaneous spinal procedures in which bone cement is injected through a small hole in the skin into a fractured vertebra in order to relieve back pain caused ...
, also known by the brand Kiva, is a similar procedure which also has poor evidence to support its use.[
]
Adverse effects
Some of the associated risks are from the leak of acrylic cement to outside of the vertebral body. Although severe complications are extremely rare, infection, bleeding, numbness, tingling, headache, and paralysis may ensue because of 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. In those who have fractures due to cancer, the risk of serious adverse events appears to be greater at 2%.[
The risk of new fractures following these procedures does not appear to be changed; however, evidence is limited,] and an increase risk as of 2012 is not ruled out. Pulmonary cement embolism is reported to occur in approximately 2-26% of procedures. It may occur with or without symptoms.[ Typically, if there are no symptoms, there are no long term issues.][ Symptoms do occur in about 1 in 2000 procedures.][ Other adverse effects include spinal cord injury in 0.6 per 1000.]
Prevalence
In the United States in 2003 approximately 25,000 vertebroplasty procedures were paid for by Medicare. As of 2011/2012 this number may be as high as 70,000-100,000 per year.
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 of percutaneous {{More citations needed, date=January 2021
In surgery, a percutaneous procedurei.e. Granger et al., 2012 is any medical procedure or method where access to inner organs or other tissue is done via needle-puncture of the skin, rather than by using ...
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
Spinal tumors are neoplasms located in either the vertebral column or the spinal cord. There are three main types of spinal tumors classified based on their location: extradural and intradural (intradural-intramedullary and intradural-extramedullar ...
. 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 vertebral compression fractures in the United States, although the distinction has largely gone away since then.
Society and culture
Cost
The cost of vertebroplasty in Europe as of 2010 was ~2,500 Euro.[ As of 2010 in the United States, when done as an outpatient, vertebroplasty costs around US$3300 while kyphoplasty costs around US$8100 and when done as an inpatient vertebroplasty cost ~US$11,000 and kyphoplasty US$16,000.] The cost difference is due to kyphoplasty being an in-patient procedure while vertebroplasty is outpatient, and due to the balloons used in the kyphoplasty procedure. Medicare in 2011 spent about US$1 billion on the procedures.[ A 2013 study found that "the average adjusted costs for vertebroplasty patients within the first quarter and the first 2 years postsurgery were $14,585 and $44,496, respectively. The corresponding average adjusted costs for kyphoplasty patients were $15,117 and $41,339. There were no significant differences in adjusted costs in the first 9 months postsurgery, but kyphoplasty patients were associated with significantly lower adjusted treatment costs by 6.8–7.9% in the remaining periods through two years postsurgery."
]
Medicare response
In response to the NEJM articles and a medical record review showing misuse of vertebroplasty and kyphoplasty, US Medicare contractor 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 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 one 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. The reimbursement policy became effective on 20 June 2011. A 2015 comparative study of Medicare patients with vertebral compression fractures found that those who received balloon kyphoplasty and vertebroplasty therapies experienced lower mortality and overall morbidity than those who received conservative nonoperative management.
Promotion
In 2015, it was reported by ''The Atlantic'' that a person associated with a medical device company that sells equipment related to the kyphoplasty procedure had edited the Wikipedia article on the subject to promote claims about its efficacy. Assertions about the positive effects of kyphoplasty have been found to be unsupported or disproven, according to independent researchers.
References
External links
Spinal Fractures Can Be Terribly Painful. A Common Treatment Isn't Helping.
NYTs 2019
{{Bone, cartilage, and joint procedures
Orthopedic surgical procedures
Bones of the vertebral column
Interventional radiology