August_Bier

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Hi team - what do you think? Still worth doing vertebroplasty?

NEJM Volume 361 — August 6, 2009 — Number 6

A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures
R. Buchbinder and Others


A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures
D. F. Kallmes and Others
 
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A

August_Bier

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Volume 361:557-568 August 6, 2009 Number 6

A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures

Rachelle Buchbinder, Ph.D., Richard H. Osborne, Ph.D., Peter R. Ebeling, M.D., John D. Wark, Ph.D., Peter Mitchell, M.Med., Chris Wriedt, M.B., B.S., Stephen Graves, D. Phil., Margaret P. Staples, Ph.D., and Bridie Murphy, B.Sc.

ABSTRACT

Background Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use.

Methods We performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms (<6 weeks or &#8805;6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months.

Results A total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (±SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6±2.9 and 1.9±3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, &#8211;0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period.

Conclusions We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment. (Australian New Zealand Clinical Trials Registry number, ACTRN012605000079640.)



And then this one:

Volume 361:569-579 August 6, 2009 Number 6

A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures

David F. Kallmes, M.D., Bryan A. Comstock, M.S., Patrick J. Heagerty, Ph.D., Judith A. Turner, Ph.D., David J. Wilson, F.R.C.R., Terry H. Diamond, F.R.A.C.P., Richard Edwards, F.R.C.R., Leigh A. Gray, M.S., Lydia Stout, B.S., Sara Owen, M.Sc., William Hollingworth, Ph.D., Basavaraj Ghdoke, M.D., Deborah J. Annesley-Williams, F.R.C.R., Stuart H. Ralston, F.R.C.P., and Jeffrey G. Jarvik, M.D., M.P.H.

ABSTRACT

Background Vertebroplasty is commonly used to treat painful, osteoporotic vertebral compression fractures.

Methods In this multicenter trial, we randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty or a simulated procedure without cement (control group). The primary outcomes were scores on the modified Roland&#8211;Morris Disability Questionnaire (RDQ) (on a scale of 0 to 23, with higher scores indicating greater disability) and patients' ratings of average pain intensity during the preceding 24 hours at 1 month (on a scale of 0 to 10, with higher scores indicating more severe pain). Patients were allowed to cross over to the other study group after 1 month.

Results All patients underwent the assigned intervention (68 vertebroplasties and 63 simulated procedures). The baseline characteristics were similar in the two groups. At 1 month, there was no significant difference between the vertebroplasty group and the control group in either the RDQ score (difference, 0.7; 95% confidence interval [CI], &#8211;1.3 to 2.8; P=0.49) or the pain rating (difference, 0.7; 95% CI, &#8211;0.3 to 1.7; P=0.19). Both groups had immediate improvement in disability and pain scores after the intervention. Although the two groups did not differ significantly on any secondary outcome measure at 1 month, there was a trend toward a higher rate of clinically meaningful improvement in pain (a 30% decrease from baseline) in the vertebroplasty group (64% vs. 48%, P=0.06). At 3 months, there was a higher crossover rate in the control group than in the vertebroplasty group (43% vs. 12%, P<0.001). There was one serious adverse event in each group.

Conclusions Improvements in pain and pain-related disability associated with osteoporotic compression fractures in patients treated with vertebroplasty were similar to the improvements in a control group.
 

algosdoc

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So was the sham really a sham? If one is disrupting the medial branches by destruction via large needle transsection, is this really a sham procedure or a placebo? The study was poorly designed. A placebo would be placement of the needle through the skin but not into the spine.
 

PMR 4 MSK

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Next item on the chopping block of pain procedures not to be covered in the future...
 

lobelsteve

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Next study in Pain Medicine:

Drug Eluting Stents vs Sham stents for Angina Pectoris.
 

Tenesma

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well Bogduk's theory is that vertebroplasty works specifically because you disrupt the medial branches and not because of the cement...
 

Jcm800

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so these articles have hit the general media as im sure you all know. It was on CNN...

ironically, i was doing one of these "worthless procedures" today, actually a kypho, and when i came to the recovery area in the hospital, i heard a group of PACU nurses discussing how i must have heard all of the hoopla and decided to do a kypho and not to do vertebroplasty because it doesnt work... so they asked me about it. amazing. I bet Kyphon will jump on this...

the nurses asked me why kypho today instead of vetebroplasty (i do like 70/30 V to K) and i told them with a straight face "It is thursday. I kypho on tuesdays and thursdays, and MWF vertebroplasty, but I was booked on friday"

but then i had to explain my rationale, which is really lack of rationale...if there is retropulsion i do kypho, despite any solid evidence to support that kypho is safer.
 

Jcm800

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can someone post the methods section to these articles. I have asked my hospital library to get it to me, but they are being slow...

I want to see what the shame really was. Did they take the trochar to the same spot, just not injection cement?

Is Burton saying its a facet block, because in the method a spinal needle was used to place local on the pedicle, this blocking the joint/mBB?

i just havent had a chance to read more than the abstract and peoples reactions. thanks
 

foxtrot

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I LOVE that the NEJM published not one, but TWO!! studies that lacked statistical significance and then put them right front and center to be soaked up by the media.


Wonder what editor there has it out for vertebroplasty. Probably some guy who owns a lot of Boniva and Oxycontin stock in his retirement portfolio. Jeez!

Really, the NEJM is becoming a crock... the Wall Street Journal had a great expose on NEJM a couple of years back that really highlighted how they make a killing off of article reprints, citations, etc. Case in point was how they made a killing off of the articles they published re: Vioxx; even though there were a lot of red flags that should have prevented those articles being published and that some people at NEJM picked up on, but chose to ignore. Bottom line is that NEJM is a business like anything else and that consequently puts their scientific acumen and publishing judgement in question.
Very well said. I actually did not renew my subscription because I feel the exact same way. Next up, not renewing my AMA membership. Talk about a joke organization.
 

Mister Mxyzptlk

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Amen. You should take a look at what they are doing on Sermo.

www.sermo.com

The Texas Medical Association and quite a few other state societies have openly split with the AMA over endorsement of the health reform bill. We feel Rohack caved under pressure from Obama when they met. Basically, Obama told Rohack if he wasn't on board he could leave the room now. Rohack stayed. His rationale was that it's better to be at the table than on the menu.

I think he should have stood up, shook Obama's hand, and told him he would not have physician support if it had to be all or none. Then he should have marched out and told the media exactly what transpired. Obama needed that endorsement and Rohack failed to call his bluff. That strong-arm crap might work in Chicago but it won't play in Texas. I know the TMA leadership was furious over it.
 

Jcm800

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Amen. You should take a look at what they are doing on Sermo.

www.sermo.com

The Texas Medical Association and quite a few other state societies have openly split with the AMA over endorsement of the health reform bill. We feel Rohack caved under pressure from Obama when they met. Basically, Obama told Rohack if he wasn't on board he could leave the room now. Rohack stayed. His rationale was that it's better to be at the table than on the menu.

I think he should have stood up, shook Obama's hand, and told him he would not have physician support if it had to be all or none. Then he should have marched out and told the media exactly what transpired. Obama needed that endorsement and Rohack failed to call his bluff. That strong-arm crap might work in Chicago but it won't play in Texas. I know the TMA leadership was furious over it.

what, chicago/illinois politics questionable? What evidence do you have to support that...wink wink. (i added that for those you dont get internet sarcasm)
 

sweetalkr

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I am presenting this article at journal club next week. I was going to post my thoughts after I read it, and i would appreciate anyone's inputs regarding the study and any major flaws you see. thanks
 
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When I read the abstract from Bogduk, published in PM, comparing vertebroplasty to thoracic MBB (May be I don't recall properly and it was RF facet denervation instead) showing no differences between groups I was intringued. As I see reading the NEJ the better results are still obtained in the VBP group but anyway the figures are modest in either case (only 3 points on the VAS as most). So do you think would be worth embarking on MB diagnostic block of the facets above and bellow the fractured vertebra before considering VBP and its feared complications?
 
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I spend a couple days this summer with a radiologist and I watched a verterbraplasty/kyphoplasty the day after that study was published. I asked the doctor who was doing the procedure about his opinion on the study and he said it flawed because it is hard to say it doesnt work when you see the improvement of the patients. The one I saw, the lady could barely walk before and after she had a great deal of pain relief and comfort. Hard to argue against improvement in a patients life.
 

ampaphb

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Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial

The Lancet, Early Online Publication, 10 August 2010

Dr Caroline AH Klazen MD, Paul NM Lohle MD, Prof Jolanda de Vries PhD, Frits H Jansen MD, Alexander V Tielbeek MD, Marion C Blonk MD, Alexander Venmans MD, Prof Willem Jan J van Rooij MD, Marinus C Schoemaker MD, Job R Juttmann MD, Tjoen H Lo MD, Harald JJ Verhaar MD, Prof Yolanda van der Graaf MD, Kaspar J van Everdingen MD, Alex F Muller MD, Otto EH Elgersma MD, Dirk R Halkema MD, Hendrik Fransen MD, Xavier Janssens MD, Prof Erik Buskens MD, Prof Willem P Th M Mali MD

Background
Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures.

Methods
Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466.

Findings
Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was &#8722;5·2 (95% CI &#8722;5·88 to &#8722;4·72) after vertebroplasty and &#8722;2·7 (&#8722;3·22 to &#8722;1·98) after conservative treatment, and between baseline and 1 year was &#8722;5·7 (&#8722;6·22 to &#8722;4·98) after vertebroplasty and &#8722;3·7 (&#8722;4·35 to &#8722;3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74—3·37, p<0·0001) at 1 month and 2·0 (1·13—2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported.

Interpretation
In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60954-3/fulltext
 

clubdeac

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Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial

The Lancet, Early Online Publication, 10 August 2010

Dr Caroline AH Klazen MD, Paul NM Lohle MD, Prof Jolanda de Vries PhD, Frits H Jansen MD, Alexander V Tielbeek MD, Marion C Blonk MD, Alexander Venmans MD, Prof Willem Jan J van Rooij MD, Marinus C Schoemaker MD, Job R Juttmann MD, Tjoen H Lo MD, Harald JJ Verhaar MD, Prof Yolanda van der Graaf MD, Kaspar J van Everdingen MD, Alex F Muller MD, Otto EH Elgersma MD, Dirk R Halkema MD, Hendrik Fransen MD, Xavier Janssens MD, Prof Erik Buskens MD, Prof Willem P Th M Mali MD

Background
Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures.

Methods
Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466.

Findings
Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was &#8722;5·2 (95% CI &#8722;5·88 to &#8722;4·72) after vertebroplasty and &#8722;2·7 (&#8722;3·22 to &#8722;1·98) after conservative treatment, and between baseline and 1 year was &#8722;5·7 (&#8722;6·22 to &#8722;4·98) after vertebroplasty and &#8722;3·7 (&#8722;4·35 to &#8722;3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74—3·37, p<0·0001) at 1 month and 2·0 (1·13—2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported.

Interpretation
In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60954-3/fulltext
PAZ, you're good. Always up on the latest articles. Luv it
 

clubdeac

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So here's a question somewhat along the same lines.

76 y/o male with osteoporosis and prior L3 vertebroplasty presenting with axial lbp. MRI from 2008 showed an L5 compression fx. MRI from one month ago showed that fx at L5 still had edema on STIR and T2. Do you do the vertebroplasty?
 

lobelsteve

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So here's a question somewhat along the same lines.

76 y/o male with osteoporosis and prior L3 vertebroplasty presenting with axial lbp. MRI from 2008 showed an L5 compression fx. MRI from one month ago showed that fx at L5 still had edema on STIR and T2. Do you do the vertebroplasty?
Brace, medicate, PMH CA?
Acute on chronic Fx is possible, but L5 is rare. I've seen 2 in 3 years.