Randomized Sham Controlled Trials in Orthopedics
This blog looks at the 14 randomized sham controlled trials that have been conducted in orthopedics. It examines the outcomes of these trials, and provides a visual surgical atlas for a proposed, Randomized, SHAM controlled trial of Total Knee Arthoplasty TKA.
Vinay Prasad MD MPH
Professor @ucsf, Physician-Scientist, Writer; More at @vkprasadlab @plenary_session, YouTube, #vpzd podcast & @Sensible__Med; Views are mine
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OUT Now!
— Vinay Prasad MD MPH (@VPrasadMDMPH) March 6, 2023
Our paper providing a visual surgical atlas for a proposed, Randomized, SHAM controlled trial of Total Knee Arthoplasty TKA
This is the 7th paper @audreyamadean did with me in her year off at OHSU & she illustrated it!
Check it out 👇
🧵https://t.co/B6PFh6s9ja pic.twitter.com/jhvzx2H0yI -
To date, there have been 14 randomized sham controlled trials we are aware of in orthopedics (full table in supplement)
— Vinay Prasad MD MPH (@VPrasadMDMPH) March 6, 2023
Ten out of 14 studies (71%) failed to demonstrate that the proposed intervention improved outcomes compared with the sham arm. pic.twitter.com/4oIePIWBH9 -
In five of ten (50%) negative studies, both intervention and control arms improved from baseline.
— Vinay Prasad MD MPH (@VPrasadMDMPH) March 6, 2023
This suggests that some interventions are beneficial, i.e. better than not performing them, but that benefit is a placebo effect. -
We draw upon this to propose the surgical technique for a sham controlled trial of TKA.
— Vinay Prasad MD MPH (@VPrasadMDMPH) March 6, 2023
To do this, one attending (VP), went back into the OR to observe surgery! One of us was closer to it (AT)
Part 1 of surgery is the same in both arms pic.twitter.com/3w2IKr9hDt -
Part 2 of surgery includes the critical steps pic.twitter.com/aAmPWJZ9zw
— Vinay Prasad MD MPH (@VPrasadMDMPH) March 6, 2023 -
The full supplement provides even more step by step details of how the SHAM surgery can be done
— Vinay Prasad MD MPH (@VPrasadMDMPH) March 6, 2023
This will mimic the intervention, but does not fix the articular surfaces pic.twitter.com/hgjt14JZEG -
Follow up will be similar pic.twitter.com/zjQPMnZtqa
— Vinay Prasad MD MPH (@VPrasadMDMPH) March 6, 2023 -
We argue in the 8 page essay that SHAM trials are not only ethical permissible, but ethical OBLIGATORY
— Vinay Prasad MD MPH (@VPrasadMDMPH) March 6, 2023
We spend tens of billion, and do this several hundred thousand times a year pic.twitter.com/PCYaJLaVj9 -
Sham trials separate the effect of the implant from the psychological effect of the surgery and physical effect of opening the knee, rest and rehab
— Vinay Prasad MD MPH (@VPrasadMDMPH) March 6, 2023
We encourage you to read the paper
One of the more ambitious projects we have done@vkprasadlab https://t.co/B6PFh6sH8I pic.twitter.com/CRWCHxdtGJ