Study shows that kypho is awesome after all

[BobBarker]

Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures: The EVOLVE Trial | Neurosurgery | Oxford Academic

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[emd123]

Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures: The EVOLVE Trial | Neurosurgery | Oxford Academic

Good to see this. It mirrors what I see in practice. To say that 90% of my kyphopatients have 90% pain relief 1 wk out, and sustained indefinitely, is not much of an exaggeration

 

[epidural man]

When will industry learn?

Wouldn't you feel better if the disclosure said "Medtronic paid for the equipment and physician compensation for time spent doing the study. However, they did not design the study, control or analyze the data, or help with the write up. They did approve the study design and paid for open source publication."

Otherwise, I am left thinking....Do I really believe it? How often do I need to get burned by big money?

It is so strange...if a company believes in a product, why are they SO AFRAID to let go of control. It really changes how I view the results...and I am sure I'm not the only one that thinks that way.

 

[ziggyziggy]

Just my experience. It might be biased but I have seen great results with kypho in comparison to everything else we do (including scs and pumps), after selecting the right patient and level.

 

[Orin]

Just my experience. It might be biased but I have seen great results with kypho in comparison to everything else we do (including scs and pumps), after selecting the right patient and level.

If it is STIR positive and the patient has pain when I push, it seems to just work assuming I don't put cement in the cord or the lungs.

 

[Ducttape]

im sorry, i wasnt going to post, but this was a non-randomized trial with no control group.

study doesnt prove much, as one would hope. no true comparison to conservative care.

its like doing appendectomies and stating that they have to be done to prevent death when one doesnt know if people really died from appendicitis.

 

[Orin]

im sorry, i wasnt going to post, but this was a non-randomized trial with no control group.

study doesnt prove much, as one would hope. no true comparison to conservative care.

its like doing appendectomies and stating that they have to be done to prevent death when one doesnt know if people really died from appendicitis.

While you're correct about the ideal study, it would be really unethical and not at all pragmatic to offer randomization to placebo/sham/active therapy in this scenario.

Who wants to roll the dice and be in the sham/control arm of a trial for a fractured hip?

To the author's credit, this is the first item listed in their Limitations section.
"""
Limitations include the fact that this is a nonrandomized open label study. In light of several RCTs recently conducted, sham- or NSM-controlled studies,11-14,29-32 in a condition that is so severely painful such as VCF, become exceedingly difficult and could introduce selection bias with the patients having a trending decrease in pain being the only ones who would volunteer for randomization to a sham or NSM group. Controlled studies with sham as a comparator as done previously may now be deemed unethical given the known significant reduction in morbidity and mortality in the surgically treated patients.1,3,4,6 Heterogeneity was introduced by including both osteoporotic and neoplastic fractures and by differing sensitivity in imaging modalities for each. Few cancer subjects enrolled but nonetheless, including both was prespecified as the primary analysis, supports generalizability and is representative of patients treated in routine clinical practice. Ninety patients (25%) were lost to follow-up for various reasons prior to 1 yr. Although this rate is not out of the ordinary for a study of this size with a mean age of 78.9 yr, the potential to introduce bias to the statistical analysis remains.
"""

 

[hyperalgesia]

While you're correct about the ideal study, it would be really unethical and not at all pragmatic to offer randomization to placebo/sham/active therapy in this scenario.

Who wants to roll the dice and be in the sham/control arm of a trial for a fractured hip?

To the author's credit, this is the first item listed in their Limitations section.
"""
Limitations include the fact that this is a nonrandomized open label study. In light of several RCTs recently conducted, sham- or NSM-controlled studies,11-14,29-32 in a condition that is so severely painful such as VCF, become exceedingly difficult and could introduce selection bias with the patients having a trending decrease in pain being the only ones who would volunteer for randomization to a sham or NSM group. Controlled studies with sham as a comparator as done previously may now be deemed unethical given the known significant reduction in morbidity and mortality in the surgically treated patients.1,3,4,6 Heterogeneity was introduced by including both osteoporotic and neoplastic fractures and by differing sensitivity in imaging modalities for each. Few cancer subjects enrolled but nonetheless, including both was prespecified as the primary analysis, supports generalizability and is representative of patients treated in routine clinical practice. Ninety patients (25%) were lost to follow-up for various reasons prior to 1 yr. Although this rate is not out of the ordinary for a study of this size with a mean age of 78.9 yr, the potential to introduce bias to the statistical analysis remains.
"""

This is an elective procedure. The vast majority of these fxs are treated conservatively and could serve as controls in a sham group.

 

[LunchMD]

This is an elective procedure. The vast majority of these fxs are treated conservatively and could serve as controls in a sham group.

That would still be a prospective cohort study if I'm understanding you correctly. There would (hopefully) be inherent differences in the patients that ultimately were selected for kypho vs conservative, so wouldn't make for great between groups outcomes comparisons. It would be interesting, however, to see what the "risk factors" for selection to kypho would be though.

From personal experience, consenting patients for RCT interventional studies is hard to do without introducing bias into the entire study population (ie same biases for both control and interventional groups, so won't see a difference in the patient characteristics analysis), as often patients will self select themselves. Eg in a study looking at using a new anesthetic drug, it might be that mostly only patients undergoing minor surgery or with less severe disease are willing to participate. Thus you might conclude the drug is safer than in "real life". This can be mitigated by strict inclusion and exclusion criteria, but that also significantly complicates and prolongs the research process. Not to say we shouldn't do RCT, but just some observations I've had.

 

[Ducttape]

While you're correct about the ideal study, it would be really unethical and not at all pragmatic to offer randomization to placebo/sham/active therapy in this scenario.

Who wants to roll the dice and be in the sham/control arm of a trial for a fractured hip?
"""

but this is exactly what needs to be done.

in case you were too young to know, it was thought unethical to do early surgery for hip fractures previously (in the 80s and early 90s) because of the supposed high risk of mortality from the surgery itself.....

this study presupposes that standard of care is kyphoplasty itself. it is an inherent bias.

 

[Orin]

but this is exactly what needs to be done.

in case you were too young to know, it was thought unethical to do early surgery for hip fractures previously (in the 80s and early 90s) because of the supposed high risk of mortality from the surgery itself.....

this study presupposes that standard of care is kyphoplasty itself. it is an inherent bias.

Yeah I wasn't around back in the day, but it looks like we've done that study, a few different times, in a few different ways, by a few different groups. The standard of care changes and the data are strongly suggestive of benefit. I don't think an IRB would allow the randomized to "non-op" arm design or that any reasonable practitioner would design a trial to test this theory.

Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the medicare po... - PubMed - NCBI
CONCLUSIONS:
Vertebral augmentation procedures appear to be associated with longer patient survival than nonoperative treatment does. Kyphoplasty tends to have a more striking association with survival than vertebroplasty does, but it is costly and may have a higher rate of subsequent vertebral compression fracture. These provocative findings may reflect selection bias and should be addressed in a prospective, direct comparison of methods to treat vertebral compression fractures.

Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials? - PubMed - NCBI
CONCLUSIONS:
Changes in treatment patterns following the 2009 VP publications led to fewer augmentation procedures. In turn, the 5-year period following 2009 was associated with elevated mortality risk in VCF patients. This provides insight into the implications of treatment pattern changes and associated mortality risks.

Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data. - PubMed - NCBI
CONCLUSION:
Results suggest a higher overall survival rate for operated than nonoperated patients with OVCF and indicate a potential survival benefit for patients who received BKP compared with patients who received PVP. The reasons merit further investigation. Total costs were lower after 4 years for patients who received BKP versus PVP due to less consumption of pharmaceuticals.

Morbidity and Mortality After Vertebral Fractures: Comparison of Vertebral Augmentation and Nonoperative Management in the Medicare Population. - PubMed - NCBI
CONCLUSION:
VCF patients in the Medicare population who received vertebral augmentation therapies, specifically BKP and VP, experienced lower mortality and overall morbidity than VCF patients who received conservative management.

Just saying, you should update your rolodex.

 

[Ducttape]

Or you should remove yourself as much as possible from financial gain when reviewing studies.

FWIW, I don’t do kyphos - they all go to IR given that almost all of them get diagnosed then immediately referred to the IR NP for evil. So I have no stake in the game. I’m also employed.

The studies you quote are all level 3 evidence and are essentially all retrospective analyses of claims data. They specifically state that more studies including prospective ones need to be done. Many factors are not accounted for, least of all that those who are sicker do not get offered kyphos- so immediately conservative care patients mortality will be higher from the start.

I’ve seen a lot of treatments touted to be the “next best thing” in the 30 year (minus 3 months) I have been a doctor. Tons of them Fall by the wayside, or have limited application nowadays. Go do a prospective randomized double blind and, if possible, crossover study with no researcher bias (of which there is plenty in this study)...

 

[Orin]

Again, I'm not arguing that there isn't money in this. There is money in everything.

Opioid safety -> $ for Naloxone
Deprescribing -> $ for for psych and adjuvants
Kypho -> $ for device companies and doing the procedure

The problem is I cannot ethically design a trial where you tell one arm that you may die sooner. That's four separate Level 3 studies by different groups, on different populations, with near identical findings. That's very suggestive of a real finding that I would be hard pressed to massage away by the need for pure clean science.

Lets walk through your request though.

Prospective - Can do, and they did! I agree this is important.

Randomized - I really can't justify this ethically, but lets say we do it as a delayed treatment vs rapid treatment. 2 - 3 months of conservative treatment with rest, analgesics, bracing, etc, can't be that bad right? It might increase mortality but if this arm gets treatment at the end if still indicated, we can probably convince an IRB of it. Some of them may not need the treatment and can become a de facto conservative arm.

Blinded - Double or Single? How do you blind holes in the back or cement? I guess you can just do a sham procedure where you drop local and then walk away without hammering into the pedicles?

Crossover - So the cement arm can't cross over right? It's already done. You could cross over the conservative arm like I stated above though.

Now we're looking at a prospective trial of BKP at 90 days vs at time of fracture, randomized, single blinded (patient and observer but not proceduralist/radiologists doing it/looking at scans) with sham injections of local anesthetic in your control arm, and then look at the outcomes done above, but you could probably do it. It's a crazy complex study though and you'd probably need a ton more patients because of the 2 - 3 arms, and a lot of money, but then if you don't want industry funds or bias, you're going to be hard pressed to get it done.

 

[hyperalgesia]

Randomized - I really can't justify this ethically, but lets say we do it as a delayed treatment vs rapid treatment. 2 - 3 months of conservative treatment with rest, analgesics, bracing, etc, can't be that bad right? It might increase mortality but if this arm gets treatment at the end if still indicated, we can probably convince an IRB of it. Some of them may not need the treatment and can become a de facto conservative arm.

You don't have to "convince an IRB" to accept standard of care medicine. Most studies on this topic are decidedly flawed and together are insufficient to play the "ethics card". Once you have clearly demonstrated, in a scientific manner, that your method is superior to others, THEN you can play the ethics card.

Not saying there's anything wrong with doing kyphos. But you can't jump the gun and say "conservative care is unethical", in the absence of a high quality RCT to back you up.

 

[Ducttape]

Your null hypothesis has, all along, been that kyphos are superior than conservative therapy. You have already made the decision that the only way to go is with kypho.

You will never be able to prove that kyphos is better than not because your mind is made up.

These studies you quote are not evidence of superiority. You made that assumption because of pulling numbers falls in your preconceived notion. As I noted before, there are many reasons why - outside of the procedure itself - that patients who got kypho did better, such as they were healthier beforehand.

You need to show that the procedure itself is what helps.

I understand not wanting to do a sham injection. But you don’t even have a study there that compares kypho directly to NO procedure...

FYI none of these studies u quoted were prospective. Please remember that.