Update on Vertebroplasty: A Unique Evidence-based Review
SOURCE: Dynamic Chiropractic
By Deborah Pate, DC, DACBR
A few years ago, I wrote an article (May 22, 2006 issue of Dynamic Chiropractic) reviewing vertebroplasty as a treatment option for painful compression fractures due to osteoporosis. [1] I felt that as chiropractors, we should be aware of the common medical procedures that are available to treat disorders we generally manage; osteoporotic compression fractures being one such entity.
From the information available at the time, vertebroplasty was considered a reasonable treatment option for painful osteoporotic vertebral compression fractures.
A recent article in the the New England Journal of Medicine has changed my impression of vertebroplasty. The article reported on a multicenter clinical trial evaluating the efficacy of percutaneous vertebroplasty for the treatment of painful osteoporotic vertebral compression fractures. [2] In the study, patients who had one to three painful osteoporotic vertebral compression fractures were randomly assigned to undergo either vertebroplasty or a simulated procedure without cement (the control group). Participants could have up to two spinal levels treated.
Participants were enrolled in the study for one year and were evaluated at entry and at one month and 12 months; and with phone calls at days one, two, three and 14, and months three and six. After month one, crossover from the placebo group to the vertebroplasty group was allowed.
Kallmes, et al., reported that pain and disability outcomes at one month in the group of patients who underwent vertebroplasty were similar to those in a control group that underwent a sham procedure. Both groups showed improvement within three days after either procedure. The cutoff for the primary outcome was one month (prior to crossover), but data were collected for three months.
Interestingly, patients who crossed over had worse outcomes than those who did not request the other intervention. More patients than predicted were able to guess which treatment they had received; therefore, there might have been a benefit in understanding the treatment effect in those who guessed their treatment accurately.
Kallmes’ conclusions were as follows: “At 1 month, clinical improvement in patients with painful osteoporotic vertebral fractures was similar among those treated with vertebroplasty and those treated with a simulated procedure. These data suggest that further studies should be undertaken to determine whether the long-term outcome is similar in the two groups, especially because our crossover study design limited our ability to shed light on the long-term efficacy of vertebroplasty.”
The authors do note that there were several limitations in regard to this trial:
- They were forced to allow crossover after one month because both physicians and patients were reluctant to accept a longer period.
- They did not compare the study groups with respect to other medical treatments they received that might have affected their outcomes.
- They did not consider that the persistence of pain after vertebroplasty or fracture healing might be due to causes of pain other than fracture; they did baseline imaging only to exclude other pathology.
- They did not examine the possibility that vertebroplasty is effective only for fractures of a certain age or healing stage.
- They limited the study to vertebroplasty and did not evaluate the efficacy of kyphoplasty, which is similar.
Another trial, this one by Buchbinder, et al., [3] and reported in the same issue of NEJM, measured pain, quality of life, and functional status at one week and at one, three and six months after active and sham vertebroplasty, finding no significant between-group differences at any time point, which further validates Kallmes’ findings. As in the Kallmes study, the patients in the two study groups had improvement in pain. What is interesting also is that in both trials, the placebo procedure involved the injection of a short-acting analgesic into the bony periosteum containing nociceptive fibers. One might question whether or not the sham was an active treatment, given the fact that there was no significant difference in results between the two treatments.
Considering the increasing use of vertebroplasty, the limited benefit and the potential risks, such as soft-tissue damage, nerve-root pain and compression related to the possible leakage of bone cement (to name the most common potential complications), one wonders how often vertebroplasty should be performed, if at all.
It’s estimated that there are 750,000 compression fractures due to osteoporosis in the United States. Only a third of patients receive treatment for these fractures and still the annualized direct-care expenditures for osteoporotic fractures in the U.S. was estimated to range from $12 billion to $18 billion in 2002. [4] I have not been able to find data covering 2003-2008, but one can be certain that the costs have not decreased.
Pain associated with these fractures can be excruciating, and before the advent of percutaneous vertebroplasty, treatment options were mainly limited to conservative management, which often meant pain medications and bed rest. (I’m not aware of any clinical trial in which chiropractic treatment was evaluated, even though many chiropractors do treat patients with compression fractures with good results.) Vertebroplasty has been used since the mid-1990s in the U.S. and since the mid-1980s in France, where it was developed.
In the past six years, the number of vertebroplasty procedures performed in the U.S. has doubled, according to the Centers for Medicare & Medicaid Services, and yet until these two recent studies, research on the efficacy of the procedure had been limited to uncontrolled, nonblinded, small case studies. Two unblinded trials have compared vertebroplasty with “medical” management; one showed better pain relief with vertebroplasty at one day and two weeks, [5] and the other showed no significant difference at three months. [6] No blinded trials had been performed or reported until recently. None of the case studies takes into account important variables including the natural tendency for compression fractures to heal spontaneously, regression toward the mean, and the placebo effect. [7]
What I find most disconcerting in light of the recent findings is that vertebroplasty has been used for past 20 years, but only now has it been reviewed for its clinical efficacy. I am summarily guilty as charged; even after reviewing the literature and reporting that this might be an option for some patients with painful compression fractures, I failed to recognize that there were no unblinded trials that confirmed this procedure’s clinical efficacy. My assumption was that it certainly must have some clinical efficacy if Western medicine had been using the procedure for 20 years!
Obviously we all need to use a more discerning eye when evaluating procedures and treatments offered to the public. Unfortunately, this information isn’t always easily available or easily understood. Clearly there needs to be a paradigm shift toward conducting research that provides sufficient clinical efficacy for procedures before they become common practice.
It will be interesting to see if the number of vertebroplasty procedures is significantly reduced in response to this reported lack of efficacy or whether kyphoplasty procedures will actually become more popular, since vertebroplasty’s efficacy has still been so poorly scrutinized thus far.
References:
- Pate D.
“Vertebroplasty for Compression Fractures.”
Dynamic Chiropractic, May 22, 2006. - Kallmes DF, Comstock BA, Heagerty PJ, et al.
A randomized trial of vertebroplasty for osteoporotic spinal fractures.
N Engl J Med, 2009;361:569-579. - Buchbinder R, Osborne RH, Ebeling PR, et al.
A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures.
N Engl J Med, 2009;361:557-568 - Carmona RH, Office of the Surgeon General.
Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD:
Department of Health and Human Services, 2004 - Voormolen MH, Mali WP, Lohle PN, et al.
Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures: the VERTOS Study.
Am J Neuroradiol, 2007;28:555-560 - Rousing R, Andersen MO, Jespersen SM, Thomsen K, Lauritsen J.
Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study.
Spine, 2009;34:1349-1354 - Weinstein JN.
“Balancing Science and Informed Choice in Decisions About Vertebroplasty.”
N Engl J Med, 2009;361:619-621
Title: Percutaneous vertebroplasty: results and complications in 4547 patients treated in
six Italian EVEREST (European vertebroplasty research team) centers
Topic: Bone and soft tissue intervention
Monday, Sep 21, 2009, 4:51 PM – 5:00 PM
Author(s): S. Marcia1, G.C. Anselmetti2, G. Bonaldi3, P. Carpeggiani4, S. Masala5, M.
Muto6, S. Marini1, A. Manca2;
Purpose: the purpose of this work was to retrospectively evaluate results and complications of
percutaneous vertebroplasty performed in 6 different Italian centers belonging to the European
Vertebroplasty Research Team (EVEREST) in a large series of patients.
Materials and methods: four thousand five hundred forty-seven patients (3211 females and 1336
males; mean age 70.2 years) underwent percutaneous vertebroplasty (PV) for a total of 13,437
treated vertebrae. Exams were performed by using fluoroscopic guidance or combined
CT-fluoroscopic guidance. All patients underwent local anesthesia except for cervical vertebras
treated with trans-oral approach.
Results: four thousand and four of 4547 (88.06%) patients had significant pain relief (difference >
or = 2 point in pain evaluated with an 11-point visual analog scale; p<0.0001) within 48 hours: an
average of 7.7±0.4 dropped to 1.8±0.6 in the osteoporotic patients; 8.3±0.4 to 2.4±0.4 in metastases;
8.3±0.4 to 1.7±1.0 in myeloma; 6.2±3.5 to 0.3±0.2 in hemangioma and 7.4±0.4 to 1.4±0.9 in trauma.
Four-hundred-thirty osteoporotic patients (13%) were retreated for a subsequent fracture; in 302/430
patients (70.2%), the new fracture occurred in the contiguous vertebra. No major neurologic
complications were reported and venous leakage was the most frequent mild one (20.5%).
Conclusions: the large series of patients confirms that percutaneous vertebroplasty is an effective
and safe procedure in the treatment of vertebral fractures, especially when high-quality radiologic
guidance is used. Best results are obtained in the treatment of myeloma and osteoporosis.
Title: 1-year results of the VERTOS II trial: vertebroplasty versus conservative therapy
Topic: Bone and soft tissue intervention
Monday, Sep 21, 2009, 4:25 PM – 4:35 PM
Author(s): C. Klazen1, P. Lohle1, F. Jansen2, M. Schoemaker1, O. Elgersma3, K. van
Everdingen4, H. Fransen5, T. Lo6, A. Tielbeek2, W. Mali6;
Purpose: presenting the results of a randomized controlled trial (RCT) comparing clinical outcome
and cost-effectiveness of vertebroplasty (VP) versus conservative therapy (CT) in patients with
painful osteoporotic vertebral compression fractures (VCF).
Materials/methods: a prospective, multicenter RCT was conducted in the Benelux in November
2005.
Inclusion criteria: VCF with bone edema on MRI, local back pain (<6 weeks), age of 50 years
or older and osteopenia. A total of 200 patients are randomized, 100 in each arm. Radiological
imaging results and standard questionnaires addressing clinical symptoms, pain medication and
visual analogue scale (VAS) will be compared to baseline and between groups. Significant pain
relief is defined as a reduction in VAS-score of 50% or more. Cost-effectiveness of both therapies
will be obtained and compared. Follow-up is at regular intervals over 1-year period. Secondary
fractures, necessary additional therapies and complications of both treatments are recorded.
Results: 1-year results will be obtained in July 2009 and presented at this year’s CIRSE meeting including clinical results, cost-effectiveness, complications and adverse events.
Conclusion: first-time presentation of the Vertos II results, the world’s first large RCT designed to assess the
value of VP in patients with acute osteoporotic VCF.
Malory,
Thanks for your posting(s). I have several issues with them:
1. The first study reports on pain relief 2 days after the procedure. That is hardly informative, and certainly does NOT predict long-term outcome, which I believe was the point of Dr. Pate’s article.
2. The second posting does nothing at all to justify Vertebroplasty. It’s a status report on an unfinished review, and it’s very unclear if it will be a rigouous meta-analysis, or just another “feel good” advertisment by surgeons to justify unproven surgeries.
3. Finally, neither of them are from a peer-reviewed journal. If these are from trade papers, or from one of the (numerous) spurious pseudo-journals we have posted about in the past, then neither of them come up to the shoe laces of the NEJM posting (in my humble opinion).
I hope you don’t mind my cleaning up your postings, so that they were readable.
1. How can you discredit this study and not the NEJM studies? 3 months does not constitute a “long-term outcome” either. This procedure has improved scores of lives for well over a decade; how can you ignore those improvements? Perhaps you’re a fan of conservative therapy (which I assume is correct because of your affiliation with chiro)? Conservative therapy is phenomenal and right for many, but not all. Vertebroplasty is similar; not all people are candidates for this procedure, but many benefit significantly.
2. Dr. Hendrich Franzen of Belgium went to a presentation on this study and here is a summary of his notes:
Pain relief was 87% for Vertebroplasty VAS went down in average for 5.7 points! For CT the pain reduction took much more time and it never equaled the VAS of VP. She showed a graph comparing both and the difference was very impressive.
She mentioned that in the NEJM study it was only 2 to 3 points VAS reduction. She also said that in the NEJM the patients did not have much pain (4 or 5 and compared to 7/8 and more in the Vertoss II study).
They compared cost and quality of life . After 1 month and 1 year the results were much better for VP than for CT.
Adjacent fractures:
15% in VP versus 24% in CT
This is the first result after 1 year but they will follow-up the patients until 2 years.
Also, she mentioned that the randomization was blind and organized by an external clinical laboratory.
3. These items have not been published in their entirity; I expect they may frequent the pages of NEJM before long (my prediction, of course). The full findings were presented at CIRSE and are supported by the majority of those who review, including NASS, AJNR, SIR, AANS, ASSR and others. More to come…
Whoa! Where did I “discredit” either study?
Have you ever heard of failed back syndrome?
While your playing online, go to PubMed (the depository for PEER-REVIEWED literature) and do a search. What you’ll find is that many of those people experienced short-term relief BEFORE they crash and burn.
You don’t see a difference between reporting responses 2 days after, versus 3 MONTHS after a procedure? I hardly know what to say.
Finally, you didn’t really address any of my concerns.
Anyone can “say” anything they like about surgery, or how to make a million bucks in the next 2 weeks. But that doesn’t make it so, does it?
The whole point of peer-review (flawed though it may be) is to review the methods and analysis of a paper BEFORE it gets into the hands of the easily impressed.
Until then, please don’t use this website as a pulpit to propound opinions that have not withstood rigorous scrutiny. I suspect that neither of us are surgeons, so let’s leave the opinions to those who “stood the test” of peer-review (like at NEJM).
I have know 4 people who have been through the procedure. Three of them have no relief whatsoever – 1 year follow up.
I personally would not recommend it either. I also know 4 people myself that have been through the procedure and 2 of them are worse.
I understand that the neurosurgeons are sincerely trying to help people. But surgery seems like such a crap shoot. To add insult to injury there’s risk of general anesthesia and a nosocomial staph infection.
What amazes me is how many people are okay to jump into this – but are deathly afraid of having their necks “cracked”.
Anyone know of any techniques as I have a pt. with Schurmans dz.
Thank You
Dr. Starza
My best friend Hal had Schurmans as a kid. Unless x-ray findings suggest significant weakening of the vertebral bodies, I would use the same techniques I use on every other patient. Hal tolerated diversified care and Pierce-Stillwagon very well…in fact, that’s what kept him asymptomatic.
I concur with Frank and Drs. Smith and Gardner and can not recommend this procedure. Vertebroplasty is just another in a long string of popular medical procedures that fail to do what they promise. Patients should be wary about undergoing any new treatment before it efficacy is proven.