This is an old revision of this page, as edited by CrunchyChewy (talk | contribs) at 03:04, 3 February 2010 (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.). The present address (URL) is a permanent link to this revision, which may differ significantly from the current revision.
Revision as of 03:04, 3 February 2010 by CrunchyChewy (talk | contribs) (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.)(diff) ← Previous revision | Latest revision (diff) | Newer revision → (diff)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