| Revision as of 02:39, 3 February 2010 view sourceVertebralcompressionfractures (talk | contribs)11 edits Previous edits are not balanced and do not account for Level 1 data in support of vertebral augmentation/vertebroplasty see Wardlaw D et al. The Lancet February 2009 for more details← Previous edit | Revision as of 03:04, 3 February 2010 view source CrunchyChewy (talk | contribs)127 edits The randomized but unblinded kyphoplasty study was published several months before the two separate double blinded randomized studies were published - an excellent demonstration of the placebo effect.Next edit → | ||
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| '''Vertebroplasty''' is a ] spinal procedure where bone cement is injected through a small hole in the skin (]) into a fractured ] with the goal of relieving the pain of osteoporotic compression fractures. | '''Vertebroplasty''' is a ] spinal procedure where bone cement is injected through a small hole in the skin (]) into a fractured ] with the goal of relieving the pain of osteoporotic compression fractures. It has been found to be ineffective in treating ] of the spine. | ||
| ⚫ | == Research == | ||
| Two studies published in ''The New England Journal of Medicine'' found no benefit to vertebroplasty:<ref name="UPI">"Studies question impact of vertebroplasty." Aug. 6, 2009: UPI.com</ref> | |||
| * In a multicenter, randomized, double-blind, placebo-controlled trial involving 131 participants who were patients with one or two painful osteoporotic vertebral fractures, vertebroplasty did not result in greater improvement than a sham procedure in overall pain, physical functioning, or quality of life at 3 or 6 months after treatment.<ref name="Buchbinder"> "A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures." ''The New England Journal of Medicine.''August 6, 2009, Volume 361:557-568, Number 6</ref> ] of the ] said his study, funded by the ], found vertebroplasty had no detectable benefit when compared with procedures that only mimicked such procedures. He advises that "vertebroplasty should not be done any longer, unless it's in the setting of a study. | |||
| == Procedure == | |||
| * In a randomized trial involving 78 participants with osteoporotic vertebral ''compression fractures'', patients who underwent vertebroplasty had improvements in pain and disability measures that were similar to those in patients who underwent a sham procedure.<ref name="Kallmes"> "A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures." ''The New England Journal of Medicine.''August 6, 2009, Volume 361:569-579, Number 6</ref> University of Virginia radiologist Avery Evans said his study, which was funded by the Australian government and Cook Medical Inc., found vertebroplasty and sham procedures offered patients nearly identical pain relief.<ref name="UPI" /> | |||
| ⚫ | The main goal of vertebroplasty is to reduce pain caused by the fracture by stabilizing the bone. Vertebroplasty is typically performed by a spine surgeon or interventional radiologist. It is a minimally invasive procedure and patients usually go home the same 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 severe lung disease who cannot tolerate sedatives well. | ||
| ⚫ | During the procedure, acrylic cement is injected with a biopsy needle into the collapsed or fractured vertebra. The needle is placed with x-ray guidance. The acrylic cement quickly dries 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.<ref name="epainbook">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</ref> | ||
| Several earlier case reports and unblinded studies had suggested that vertebroplasty provided effective relief of pain.<ref>Hulme PA , Krebs J, Ferguson SJ, Berlemann U. "Vertebroplasty and Kyphoplasty: A Systematic Review of 69 Clinical Studies." ''Spine'' 2006;31(17):1983-2001</ref><ref>McGraw JK, Lippert JA, Minkus KD, Rami PM, Davis TM, Budzik RF. "Prospective evaluation of pain relief in 100 patients undergoing percutaneous vertebroplasty: results and follow-up." ''Journal of Vascular and Interventional Radiology'' 2002;13(9 pt 1):883-886.</ref><ref>Layton, KF et al. "Vertebroplasty, First 1000 Levels of a Single Center: Evaluation of the Outcomes and Complications." ''American Journal of Neuroradiology'' April 2007,28:683-89</ref> However, none of them had the benefit of double-blind comparisons against placebos and randomized samples of patients. | |||
| == |
== Procedure == | ||
| ⚫ | The main goal of vertebroplasty is to reduce pain caused by the fracture by stabilizing the bone. Vertebroplasty is typically performed by a spine surgeon or interventional radiologist. It is a minimally invasive procedure and patients usually go home the same 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 severe lung disease who cannot tolerate sedatives well. | ||
| Vertebroplasty was first performed in France in the mid 1980’s by Drs. Deramond and Galibert with the first US procedures being performed at the University of Maryland during the early 1990’s. <ref>Halpin R, Bendok B. “Minimally Invasive Treatments for Spinal Metastases: Vertebroplasty, Kyphoplasty and Radiofrequency Ablation. Supportive Oncology 2(4):339-355 2004]</ref> The indications for vertebroplasty are for the treatment of painful vertebral compression fractures due to osteoporosis and cancer. Vertebroplasty is typically performed for patients who have failed a course of conservative treatment who still have a significant amount of back pain. <ref name="Lane">Lane J, Johnson C et al. Minimally Invasive Options for the Treatment of Osteoporotic Vertebral Compression Fractures. 33(2):431-438 2002</ref> | |||
| There are approximately 750,000 vertebral compression fractures (VCFs) due to osteoporosis that occur in the US each year with only 1/3 being diagnosed by physicians.<ref>Melton L, Thamer M, Ray N et al. Fractures attributable to osteoporosis: report from the National Osteoporosis Foundation. J Bone Miner Res 12:16-23 1997</ref><ref name="Papaioannou">Papaioannou A, Watts N et al. Diagnosis and Management of Vertebral Fractures in Elderly Adults. Am J Med 113:220-228 2002</ref> Approximately 130,000 patients with painful VCF are treated with minimally invasive surgery (vertebroplasty or kyphoplasty) annually in the US.<ref>Millenium Research Group. Global Markets for Minimally Invasive Vertebral Compression Fracture Treatments 2010. RPGL20VE09 December 2009</ref> VCFs are most common in the aged population where bone quality has deteriorated due to osteoporosis (the disease characterized by bone loss increasing the risk of fragility fractures including hip, vertebra and wrist). Prior to vertebroplasty and kyphoplasty, VCFs were treated strictly with conservative medical management which included pain medications, bracing and bed rest.<ref name="Papaioannou" /> Several studies have documented a decrease in mobility, patient quality of life and life expectancy due to osteoporotic vertebral compression fractures indicating it is a significant problem for elderly patients.<ref>Gold D. The Clinical Impact of Vertebral Fractures: Quality of Life in Women with Osteoporosis. Bone 18:1855-1895 1996</ref><ref>Kado D, Browner W et al. Vertebral Fractures and Mortality in Older Women. Arch Inter Med 159:1215-1220 1999</ref><ref>Cauley, J Thompson D et al. Risk of Mortality Following Clinical Fractures. Osteoporosis International 11:556-561 2000</ref> Economic studies have shown there are over 100,000 admissions due to VCFs in the US each year costing in excess of $500 Million/year in the United States alone.<ref>Gehlbach S, Burge T, et al. Hospital care of osteoporosis-related vertebral body fractures. Osteoporosis International 14:53-60; 2003</ref><ref>Riggs B, Melton L. The Worldwide Problem of Osteoporosis: Insights Afforded by Epidemiology. Bone 17:505S-511S 1995</ref> As pain medication and bed rest can exacerbate the degree of bone loss and decrease patient mobility leading to other medical problems, the use of minimally invasive treatments like vertebroplasty and kyphoplasty have become increasingly common in the US and Europe to relieve pain and regain patient mobility.<ref name="Lane" /><ref>Garin S, Yuan H. et al. New Technologies in Spine. 26(14):1511-1515 2001</ref> | |||
| ⚫ | == |
||
| A Pub Med search returns over 1400 publications for the search word vertebroplasty. These publications vary from simple case series to prospective studies on the efficacy and reported complications of vertebroplasty in patients with osteoporotic and cancer related VCFs. Significant reduction or complete pain relief has been reported in 70-90% of patients treated with vertebral compression fractures due to Osteoporosis and Cancer.<ref>Hulme PA , Krebs J, Ferguson SJ, Berlemann U. "Vertebroplasty and Kyphoplasty: A Systematic Review of 69 Clinical Studies." Spine 2006;31(17):1983-2001</ref><ref>McGraw JK, Lippert JA, Minkus KD, Rami PM, Davis TM, Budzik RF. "Prospective evaluation of pain relief in 100 patients undergoing percutaneous vertebroplasty: results and follow-up." Journal of Vascular and Interventional Radiology 2002;13(9 pt 1):883-886</ref><ref>Layton, KF et al. "Vertebroplasty, First 1000 Levels of a Single Center: Evaluation of the Outcomes and Complications." American Journal of Neuroradiology April 2007,28:683-89</ref><ref>Jensen M, Dion J et al. Vertebroplasty relieves osteoporosis pain. Diagnostic Imaging 19(86):71-72 1997</ref><ref>Gangi A, Kastler B. et al. Percutaneous vertebroplasty guided by a combination fo CT adn fluroscopy. Am J Neuroradiology 15:83-86 1994</ref><ref>Dufresne A, Brunet E et al. Percutaneous vertebroplasty of the cervicothoracic junction using an anterior route: technique and results. J Neuroradiol 25:123-128 1998</ref><ref>Cortet B, Cotton A et al. Percutaneous vertebroplasty inpatients with osteolytic metastases or multiple myeloma. Rev Rhum Engl Ed 64:177-183 1997</ref><ref>Voormolen M, Lohle P et al. Prospective clinical follow-up after percutaneous vertebroplasty in patietns with painful osteoporotic vertebral compression fractures. J Vasc Interv Radiol 17(*):1313-1320 2006</ref><ref>Singh A, Pilgram T et al. Osteoporotic compression fractures: outcomes after single-versus multiple-level percutaneous vertebroplasty. Radiology 238(1):211-220 2006</ref><ref>McGirt M, Parker S et al. Vertebroplasty and kyphoplasty for the treatment of vertebral compression fractures: an evidenced-based review of the literature. Spine J 9(6):501-508 2009</ref><ref>Trout A, Kallmes D et al. Evaluation of vertebroplasty with a validated outcome mesuare: the Roland-Morris Disability Questionnaire. AJNR 26(10):2652-2657 2005</ref><ref>Trout A, Gray L, Kallmes D. Vertebroplasty in the inpatient population. AJNR Am J Neuroradiol. 26(7):1629-1633 2005</ref><ref>DO H, Kim B et al. Prospective analysis of clinical outcomes after percutaneous vertebroplasty for painful osteoporotic vertebral body fractures. AJNR 26(7):1610-1611</ref><ref>M.J. McGirt et al. The Spine Journal Jan 2009 501-508</ref> | |||
| One (1) prospective randomized, controlled clinical trial was recently published in the Lancet, by Wardlaw et al. in 2009 (FREE Study) comparing kyphoplasty (a similar procedure to vertebroplasty) to conservative management for patients suffering from vertebral compression fractures.<ref>Wardlaw D, Cummings S. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomized controlled trial. The Lancet. DOI:10.1016/S0140-6736(09)60010-6 February 2009</ref> The study found a significantly greater quality of life increase (SF-36 PCS score p<0.0001) for patients who underwent kyphoplasty when compared to those who followed a course of medical management at 1 month, 3 months and 1 year post operatively. The study enrolled 300 patients (138 in the kyphoplasty group and 128 in the control group). | |||
| Two prospective, randomized, controlled, blinded clinical studies were recently published in The New England Journal of Medicine (NEJM) in August of 2009. These two studies (Kallmes D et al. and Buchbinder R. et al.) compared vertebroplasty to a sham procedure (facet injections)<ref>Buchbinder, Rachelle, et al. "A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures." The New England Journal of Medicine.August 6, 2009, Volume 361:557-568, Number 6</ref><ref>Kallmes, David F., et al. "A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures." The New England Journal of Medicine.August 6, 2009, Volume 361:569-579, Number 6</ref> Combined, the two studies enrolled 209 patients (103 to vertebroplasty and 106 to sham treatment) and compared pain reduction on visual analog scale (1-10 with 10 being worst imaginable pain). Both studies concluded that vertebroplasty was no more beneficial than sham procedure at decreasing pain levels in patients with vertebral compression fractures at 3 months, 6 months and 1 year post treatment. The lead authors have suggested their results call into question the value of vertebroplasty as they are the only randomized controlled clinical trials comparing a sham procedure to vertebroplasty. Since their publication, these two papers have generated significant media attention in the lay press, referencing the NEJM articles, and questioning whether vertebroplasty should be performed. Another study published in Australia found little difference in pain relief between pateints treated with vertebroplasty and those that received a sham procedure but it was not a randomized controlled, clinical trial.<ref>"Studies question impact of vertebroplasty." Aug. 6, 2009: UPI.com</ref> | |||
| In response to the two NEJM publications, multiple professional societies including the North American Spine Society (NASS), the Society for Interventional Radiology (SIR) and the American Journal of Neuroradiology (AJNR) have published official responses to the recent New England Journal of Medicine vertebroplasty articles. These societies have applauded the effort that was involved with performing these studies but also pointed out numerous flaws. <ref>http://www.spine.org/Pages/ConsumerHealth/NewsAndPublicRelations/NewsReleases/2009/NASSRespondsVertebroplasty.aspx</ref> <ref>http://www.ajnr.org/cgi/reprint/ajnr.A1875v1?ck=nck</ref> <ref>http://www.sirweb.org/news/newsPDF/facts/Commentary_SIR_vertebroplasty.pdf</ref> | |||
| Significant scrutiny of the NEJM studies has lead to the following criticisms: | |||
| 1. Patient Selection Bias: 64% and 70% of the patients who met the inclusion criteria for the two NEJM studies refused to participate indicating the most painful patients requested vertebroplasty rather than risk randomization in the study. | |||
| 2. Both studies enrolled patients with fractures up to 1 year old with pain scores as low as 3 out of 10 on visual analog scale. These patients are not representative of the typical patient who benefits from vertebroplasty, whose pain scores are routinely higher (7-9 out of 10) and are significantly less mobile. | |||
| 3. Crossover rates: 1 or 3 months after initial treatment, patients in the Kallmes study from either arm were allowed to crossover (allowed to switch treatments). Crossover rates in patients who received the sham procedure were significantly higher (43%) compared to those that received vertebroplasty (12%). | |||
| 4. The Kallmes study actually reported a trend towards higher clinically meaningful pain improvement in the vertebroplasty group but did not have enough patients enrolled to demonstrate statistical significance (only 68 of 113 patients received vertebroplasty). | |||
| 5. The control groups (sham procedure) for both studies received facet blocks. Facet blocks have been reported to provide pain relief for up to 12 weeks post injection, especially in patients with older VCFs. This calls into question whether the control groups actually represented non-treatment. | |||
| The need for further studies is important to continue to understand which patients will benefit from vertebroplasty and which succeed with conservative management. The prospective randomized studies Vertos and Vertos II should offer more information on appropriate patient selection. | |||
| ⚫ | During the procedure, acrylic cement is injected with a biopsy needle into the collapsed or fractured vertebra. The needle is placed with x-ray guidance. The acrylic cement quickly dries 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.<ref name="epainbook">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</ref> | ||
| == Risks == | == Risks == | ||
| Some of the associated risks that can be produced are from the |
Some of the associated risks that can be produced are from the leak of acrylic cement outside | ||
| of the vertebral body. Although severe complications are extremely rare, it is important to know that infection, bleeding, numbness, tingling, headache, and paralysis may ensue due to 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.<ref name="epainbook" /> When the cement has leaked into blood vessels, heart and lung damage and some deaths have occurred.<ref name="Grady" >Grady, Denise. "Studies Question Using Cement for Spine Fractures." ''New York Times.'' 8/6/2009, p18, 0p</ref> | |||
| == Kyphoplasty |
== Kyphoplasty == | ||
| A related procedure known as ''']''' or more recently referred to as ''percutaneous vertebral augmentation'' involves the creation of a cavity in a collapsed vertebra, followed by injection of bone cement to stabilize the fracture. Reduction of the fracture including height restoration can occur in some acute fractures. The benefit of percutaneous vertebral augmentation is it creates a space for cement placement and often utilizes a much thicker bone cement providing the physician more control during cement delivery. This decreases the risk of cement leakage where it was not intended, potentially leading to fewer complications. You can read more about kyphoplasty/percutaneous vertebral augmentation on Misplaced Pages. | |||
| A related procedure known as ''']''' involves placement of a balloon into a collapsed vertebra, followed by injection of bone cement to stabilize the fracture. This procedure is more commonly performed in the hospital setting. It requires the use of slightly bigger needles than the vertebroplasty procedure, and therefore there is typically slightly more post-procedural pain. The failure of placebo-controlled trials to demonstrate any efficacy for vertebroplasty casts doubt on the benefit of kyphoplasty for which placebo-controlled studies have not been performed. | |||
| == See also == | == See also == | ||
| * ] | * ] | ||
| * |
* ] | ||
| * ] | * ] | ||
| * ] | |||
| == References == | == References == | ||
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Revision as of 03:04, 3 February 2010
Vertebroplasty is a medical spinal procedure where bone cement is injected through a small hole in the skin (percutaneously) into a fractured vertebra with the goal of relieving the pain of osteoporotic compression fractures. It has been found to be ineffective in treating compression fracture of the spine.
Research
Two studies published in The New England Journal of Medicine found no benefit to vertebroplasty:
- In a multicenter, randomized, double-blind, placebo-controlled trial involving 131 participants who were patients with one or two painful osteoporotic vertebral fractures, vertebroplasty did not result in greater improvement than a sham procedure in overall pain, physical functioning, or quality of life at 3 or 6 months after treatment. Jeffrey Jarvik of the University of Washington said his study, funded by the National Institutes of Health, found vertebroplasty had no detectable benefit when compared with procedures that only mimicked such procedures. He advises that "vertebroplasty should not be done any longer, unless it's in the setting of a study.
- In a randomized trial involving 78 participants with osteoporotic vertebral compression fractures, patients who underwent vertebroplasty had improvements in pain and disability measures that were similar to those in patients who underwent a sham procedure. University of Virginia radiologist Avery Evans said his study, which was funded by the Australian government and Cook Medical Inc., found vertebroplasty and sham procedures offered patients nearly identical pain relief.
Several earlier case reports and unblinded studies had suggested that vertebroplasty provided effective relief of pain. However, none of them had the benefit of double-blind comparisons against placebos and randomized samples of patients.
Procedure
The main goal of vertebroplasty is to reduce pain caused by the fracture by stabilizing the bone. Vertebroplasty is typically performed by a spine surgeon or interventional radiologist. It is a minimally invasive procedure and patients usually go home the same 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 severe lung disease who cannot tolerate sedatives well.
During the procedure, acrylic cement is injected with a biopsy needle into the collapsed or fractured vertebra. The needle is placed with x-ray guidance. The acrylic cement quickly dries 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.
Risks
Some of the associated risks that can be produced are from the leak of acrylic cement outside of the vertebral body. Although severe complications are extremely rare, it is important to know that infection, bleeding, numbness, tingling, headache, and paralysis may ensue due to 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. When the cement has leaked into blood vessels, heart and lung damage and some deaths have occurred.
Kyphoplasty
A related procedure known as kyphoplasty involves placement of a balloon into a collapsed vertebra, followed by injection of bone cement to stabilize the fracture. This procedure is more commonly performed in the hospital setting. It requires the use of slightly bigger needles than the vertebroplasty procedure, and therefore there is typically slightly more post-procedural pain. The failure of placebo-controlled trials to demonstrate any efficacy for vertebroplasty casts doubt on the benefit of kyphoplasty for which placebo-controlled studies have not been performed.
See also
References
- ^ "Studies question impact of vertebroplasty." Aug. 6, 2009: UPI.com
- Buchbinder, Rachelle, et al. "A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures." The New England Journal of Medicine.August 6, 2009, Volume 361:557-568, Number 6
- Kallmes, David F., et al. "A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures." The New England Journal of Medicine.August 6, 2009, Volume 361:569-579, Number 6
- Hulme PA , Krebs J, Ferguson SJ, Berlemann U. "Vertebroplasty and Kyphoplasty: A Systematic Review of 69 Clinical Studies." Spine 2006;31(17):1983-2001
- McGraw JK, Lippert JA, Minkus KD, Rami PM, Davis TM, Budzik RF. "Prospective evaluation of pain relief in 100 patients undergoing percutaneous vertebroplasty: results and follow-up." Journal of Vascular and Interventional Radiology 2002;13(9 pt 1):883-886.
- Layton, KF et al. "Vertebroplasty, First 1000 Levels of a Single Center: Evaluation of the Outcomes and Complications." American Journal of Neuroradiology April 2007,28:683-89
- ^ 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
- Grady, Denise. "Studies Question Using Cement for Spine Fractures." New York Times. 8/6/2009, p18, 0p
External links
- A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures
- Percutaneous vertebroplasty: New treatment for vertebral compression fractures
- Vertebroplasty: RadiologyInfo.org
- Vertebroplasty.org