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Vertebroplasty and kyphoplasty a point of debate for vertebral compression fracture treatment
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A 2007 study claimed that an estimated 1.7 million vertebral compression fractures occur every year in Europe and the United States. These fractures occur in a range of people — from young trauma patients with healthy bones to older patients with osteoporosis suffering cumulative events. While each patient’s situation is different, the two most frequently debated interventions are vertebroplasty and the relatively new kyphoplasty.
Long-term comparison studies are still underway for both procedures, though evidence is mounting that each has particular advantages over the other.
“There is very strong evidence to show that [kyphoplasty] does restore vertebral body height, which is the big advantage over vertebroplasty,” Douglas Wardlaw, MB, MhB, ChM, FRCSEd, told Orthopaedics Today Europe. “The results, in terms of pain relief and quality of life, are still significant at 2 years. That is proven.”
Wardlaw described the handling of vertebral compression fractures (VCFs) as “case-by-case,” noting that if the fractures are minimal — which he defined as less than 15° — he would watch them for 10 days to 2 weeks to see if stability developed.
“But most of them are more than that, and sometimes they gradually increase,” he said. “In the early stages I would offer kyphoplasty without a shadow of a doubt, because there is a good chance of restoring significant height.”
He added that the age of the injury can have a large impact on how a VCF should be handled.
Enric Càceres Palou, MD, PhD, FRC, said there is good evidence that vertebroplasty can provide superior pain control in the first 2 weeks, noting that “fair evidence” has found vertebroplasty to use less analgesia, result in less disability and offer greater improvement in general health when compared to optimal medical management 3 months after intervention. After 2 years, he added, vertebroplasty provides a similar degree of pain control and physical function to optimal medical management.
“There were no differences between vertebroplasty and optimal medical management in any outcome measure at 12 and 24 months in any of three level II studies published,” Càceres told Orthopaedics Today Europe. “However, the reported incidence of symptomatic, procedure-related morbidity for both vertebroplasty and kyphoplasty is low.”
Comparable evidence also suggests that kyphoplasty results in greater improvement in daily activity, physical function and pain relief when compared to optimal medical management after 3 and 6 months — but evidence is insufficient to say whether it provides greater pain relief 1 or 2 years after intervention, Càceres said.
The New England Journal of Medicine papers
Two separate papers, published in the August 6, 2009 New England Journal of Medicine, called into question the validity of vertebroplasty as an effective procedure over control or sham procedures. Physicians told Orthopaedics Today Europe that there are many questions surrounding the two papers, including the validity — or even potential effectiveness — of the sham procedure used.
“You would not expect a placebo effect to last more than 2 or 3 months. Ideally the studies should have had a control group without any treatment in it, and that would have solved the question of whether or not the sham procedure was having any effect at all,” Wardlaw said, noting that the local anesthetic used as part of Kallmes’ sham procedure could have its own significant effect over time.
Thomas R. Blattert, MD, PhD, described the studies as having “come out at the right time,” noting that they spurred discussion and encouraged physicians to think from different perspectives — even if the studies themselves have limitations.
“If they were repeated with clearer designs stating that every patient … must have an MRI finding with a positive signal, then I would be happy to see that study,” he told Orthopaedics Today Europe.
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Image: Wardlaw D |
Expanding indications
“Indications for vertebroplasty or kyphoplasty in osteoporotic fractures extend to vertebral fractures of less than 8 weeks with an increasing deformity of the vertebra,” Càceres said.
He added that a new indication for kyphoplasty, in combination with posterior short-segment instrumentation, could be non-osteoporotic, traumatic burst fractures. “This combination has provided good results.”
Blattert said that he would use vertebroplasty for prophylactic stabilization of painful conditions that have not yet caused a fracture of vertebral bodies. He would be more likely to use kyphoplasty if a fracture has already occurred and the patient is in pain.
Younger patients with traumatic fractures and good bone quality require a different approach. “Usually in these patients, if they have a burst fracture, the adjacent disc is destroyed,” Blattert said. “Because of that, our treatment for these situations is posterior short-segment instrumentation, discectomy, vertebrectomy and anterior cage interposition.”
In traumatic fractures with underlying osteoporosis, the disc may be intact but the bone will be fractured — which Blattert said would indicate kyphoplasty and posterior short-segment instrumentation with additional cement augmentation of pedicle screws.
The dangers of cement use
Wardlaw described the various risks of cement use — leakage, embolization of cement down the venal system, the escape of cement into the spinal canal — but noted that these are all well-known risks which actually display another potential advantage of kyphoplasty over vertebroplasty.
“In vertebroplasty, the bone cement is basically escaping through the fracture crevices and effectively cementing all the fragments together,” he said. “It needs to be a more fluid form to be able to do that, whereas when we are doing kyphoplasty … we wait until the cement is pretty viscous.”
Wardlaw went on to describe kyphoplasty as “a much more controlled procedure,” with less room for complications.
“The most valuable effect achievable through kyphoplasty is the markedly reduced rate of cement leakage,” Càceres said. “The overall risks of the procedure are low, but serious complications — including spinal cord compression — can occur. With good patient selection and careful technique, these complications are avoidable and make the risk-to-benefit ratio highly favorable.”
Blattert said some complications are much easier to deal with than others, and that the discussion of cement leakage should always include differentiation in terms of where the cement is going.
“No problem [if cement leaks] in the soft tissue, big problem in the epidural space, major problem as an emboli in the draining segmental vessels and also a potentially major problem in the adjacent disc,” he said. “If you have cement in the adjacent discs, this causes the biomechanical properties of the disc itself to stiffen.”
He added that the risk for an adjacent subsequent vertebral body fracture is increased when cement is accidentally injected into a disc.
The type of cement matters
“There are newer cements … which have hydroxyapatite as part of the composition, so once they are hard the bone actually actively attaches itself to the cement and the cement becomes — biomechanically and biologically — part of the bone structure,” Wardlaw said, adding he would be encouraged to use cement with hydroxyapatite in younger patients but has not yet because of availability and cost.
Blattert agreed with the assertion that a cement capable of bonding with bone would be ideal.
“If there was a biomaterial — a calcium phosphate-based injectable — I would certainly prefer that to PMMA [polymethylmethacrylate] because I would expect this biomaterial to osteointegrate into the vertebral body, whereas the PMMA does not have any biological reaction with the surrounding bone,” he said, adding that PMMA is currently the strongest biomechanical option.
“To my knowledge, there is no calcium phosphate-based biomaterial on the market that would be suitable for these indications due to the fact that it is biomechanically inferior,” he said.
Complications beyond cement
According to Càceres, most early complications of vertebroplasty and kyphoplasty can be divided into three groups:
- Systemic complications, such as cardiovascular changes, fat embolism and fever that are resolved in 2 to 4 days;
- Local complications related to technique or incorrect hardware placement; and
- Local complications due to extrusion of cement outside the vertebra.
He also noted that delayed complications can include a re-fracture or an insufficiency fracture of the cemented vertebrae, fractures of the adjacent level and delayed dislocation of cement.
“Infectious complications, although rare, have been reported,” Càceres said. “There are several reports of osteomyelitis requiring corpectomy. Complications related to the technique include postoperative epidural bleeding, injury to the neural elements, temporary radicular pain, vascular injuries, dural tears and rib, pedicle or sternum fractures.”
The potential dangers of vertebroplasty and kyphoplasty, however, are just that — potential. According to Càceres, both procedures are very safe if the appropriate steps are taken to prevent complications.
“Vertebroplasty and kyphoplasty are good techniques,” he said, though he cautioned the procedures have “serious potential complications that can lead to irreversible consequences for the patient — even death.”
He added that proper training and adherence to guidelines can allow for the techniques to be carried out with “a low complication rate and good results.” – by Robert Press
References:
- Buchbinder R. N Engl J Med. 2009;361:557-568.
- Kallmes DF. N Engl J Med. 2009;361:569-579.
- Klazen CAH, Lohle PNM, de Vries J, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010. doi: 10.1016/S0140-6736(10)60954-3.
- Taylor RS. Eur Spine J. 2007;16(8):1085-1100. doi:10.1007/s00586-007-0308-z.
- Douglas Wardlaw, MB, MhB, ChM, FRCSEd, can be reached at the Orthopaedic Unit, Woodend Hospital, Eday Road, Aberdeen, U.K. AB15 6ZQ; +44(0)1224 556055; e-mail: d.wardlaw@nhs.net.
- Enric Càceres Palou, MD, PhD, FRC, can be reached at the Orthopaedic Unit, Hospital de la Vall d’Hebron Barcelona, Passeig de la Vall d’Hebron, 119-129 08035 Barcelona; +34-93-489-30-00 / +34-93-274-60-00; e-mail: enric.càceres@efort.org.
- Thomas R. Blattert, MD, PhD, can be reached at the Department for Spinal Diseases and Spine Surgery, Orthopaedische Fachklinik Schwarzach/Munich, Dekan-Graf-Strasse 2-6, D-94374 Schwarzach, Germany; +49-0-9962-209-571; e-mail: thomas.blattert@ofks.de. He is a paid consultant to DePuy, Medtronic, and Synthes.
Does vertebroplasty provide greater pain relief than conservative treatment for patients with osteoporotic vertebral compression fractures?
VERTOS II trial
With our VERTOS II trial, we found that in patients with acute vertebral compression fractures (VCFs) with persistent severe pain, percutaneous vertebroplasty performed 6 weeks after the onset of symptoms resulted in quicker and greater pain relief than did conservative treatment. After percutaneous vertebroplasty, patients had significant pain relief and used a lower class of drugs than did those receiving conservative treatment, or no drugs at all. With conservative treatment, pain relief was slower and less than with percutaneous vertebroplasty, and the required amount of pain medication tended to increase during the first month. Selection of optimal pain treatment and the psychological effect of care and daily attention accounted for the decrease in VAS score in the conservative treatment group during the first week.
The increased pain relief after percutaneous vertebroplasty remained significant throughout 1 year of follow-up. This finding is remarkable, since fracture healing in the control group should be completed within several months.
For both quality of life and function, improvement with time was significantly greater and quicker after percutaneous vertebroplasty than with conservative treatment.
Caroline A.H. Klazen, MD, is from the Department of Radiology, St. Elisabeth Ziekenhuis, Tilburg, The Netherlands.
More well-designed studies needed
The publication of two articles last year in the New England Journal of Medicine induced tempered discussions about the reported ineffectiveness of vertebroplasty; these findings contradicted several cohort studies as well as my own experience with pain reduction after cement augmentation.
The VERTOS II trial has produced results that favor vertebroplasty, and although these studies all seem to talk about the same procedure, they do not necessarily address the same group of patients. In several investigations, the acuity of the fracture, the determination of intravertebral mobility or instability and possible concomitant diseases were not clearly defined or were not within a well-defined range.
Augmentation of vertebral bodies with cement is a method of intravertebral stabilization and not a pure pain treatment. Hence, an osteoporotic patient with a recent vertebral fracture and short-term back pain seems to benefit more from cement augmentation, as seen in the VERTOS II trial.
This emphasizes the necessity of defining promising and less promising subgroups of patients and circumstances instead of praising certain products.
Josef G. Grohs, MD , is Professor of Orthopaedic Surgeon in the Spine Unit, Dept. of Orthopaedic Surgery, Medical University Vienna, Austria.
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