Vertos 5: Vertebroplasty versus Placebo

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drusso

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If I were a placebo KOL, believed in the power of intentional healing, or psychokinetic properties of local anesthetics, I'd be pissed...



"The strength of this trial is that nearly all participants (94%) were convinced they received the actual cementation, with no crossovers. In other words, the placebo effect (expectations of pain relief) was high, but nevertheless, PV was significantly better than active control (placebo) for pain and health-related quality of life."

"Compared with active control, percutaneous vertebroplasty (PV) intervention led to pain reduction and better health-related quality of life in participants with chronic osteoporotic vertebral compression fracture. We believe that future research should focus on PV versus true sham intervention in a multicenter trial with at least 1 year of follow-up."

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It looks like the average time prior to intervention was approximately 172 days and main criteria was this pain attributed to the fracture and edema on STIR images. I wouldn't really classify that as chronic, I know based on timeline greater than 3 months it is but to me, STIR positive isn't really chronic they're may be a chronic antecedents fracture but there's still acute to subacute changes happening or the edema is just some sign of instability in that fracture. I felt the title was a bit misleading because when I read it I assumed they were talking about the compression fracture that we sometimes see in clinic which have been present for a long time (i.e. a year or more). So for me I'm not sure how much this article would change practise, if someone has STIR changes then they're still some healing to be had again I may have misunderstood the article but I thought it was for fully healed fractures (which shouldn't be causing significant pain). The other thing I was curious about was how many of these patients had progressive collapse on their fracture on repeat imaging versus stability despite the STIR changes. Also Is this a common practice to provide local infiltration on the pedicle?
 
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i would never have suspected that Beall would post anything that would go counter to any procedure. he has never seen a procedure he doesnt like.

his article supported this contention.


i agree with interjectionrelfection comments - 3 months, but with continued edema suggests continued healing, not chronic. regardless, the study seems pretty well done, and patients did have benefit - although placebo group did too, just not as much.
 
If I were a placebo KOL, believed in the power of intentional healing, or psychokinetic properties of local anesthetics, I'd be pissed...



"The strength of this trial is that nearly all participants (94%) were convinced they received the actual cementation, with no crossovers. In other words, the placebo effect (expectations of pain relief) was high, but nevertheless, PV was significantly better than active control (placebo) for pain and health-related quality of life."

"Compared with active control, percutaneous vertebroplasty (PV) intervention led to pain reduction and better health-related quality of life in participants with chronic osteoporotic vertebral compression fracture. We believe that future research should focus on PV versus true sham intervention in a multicenter trial with at least 1 year of follow-up."

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Is a lower QUALEFFO score a GOOD thing?
 
If there is no STIR edema, no kypho. Treat with MBB where it hurts. Don't use kypho to treat healed Fxs.
Have you ever seen persistent STIR edema around old kyphoplasty cement? Let’s say kypho done longer than 6 months ago by outside physician, and there is persistent correlating back pain with STIR. I’ve seen this a couple times, and not sure how to treat aside from meds and MBBs. Would treating with additional cement be appropriate?
 
Have you ever seen persistent STIR edema around old kyphoplasty cement? Let’s say kypho done longer than 6 months ago by outside physician, and there is persistent correlating back pain with STIR. I’ve seen this a couple times, and not sure how to treat aside from meds and MBBs. Would treating with additional cement be appropriate?
It could be but not reimbursed. Would do MBB/RF. I have seen Bealle and his disciples do repeat kypho in same bone for inadequate fills.
 
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Where exactly is the acute/subacute/chronic definition for VCFs as per CMS guidelines? I never know what to tell people.
 
Where exactly is the acute/subacute/chronic definition for VCFs as per CMS guidelines? I never know what to tell people.
Acute 0-6 weeks
Subacute 6-12 weeks
Chronic >12 weeks
 

In our experience, supported by the results of this study, we consider it fundamental that the patient undergo a pre-operative MRISTIR and scintigraphic evaluation in the presence of a vertebral fracture dated less than 3/4 months (Figure 1 a,b). Contrary to this, because the signal intensity areas seen on MRI-STIR in acute and subacute compression fractures change after 2-4 months and gradually revert to normal, the gold standard in the evaluation of old fractures (>3/4 months) becomes bone scan scintigraphy (Figure 2 a,b).
 
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