Hundreds of thousands of knee arthroscopic meniscus repairs are done. At a cost of $10,000 per surgery. Now let me tell you about the FIDELITY trial follow-up at 10 years.
The single health care system in Denmark may make it easier to do clinical trials, as it's easier to recruit patients and follow them up. I did a story a few years ago about clinical trials of rare diseases, and Denmark can pool its patients with countries like Australia and the UK etc, but it's hard with the US because of different insurance pathways and legal liability etc.
Just a quick comment about the tag line, the arthroscopic partial meniscectomy described in the study is not a “meniscus repair,” which would be a procedure that attempts to preserve and not remove meniscus (shown to lead to higher rates of arthritis). Orthopedic literature across the board is pretty weak for the difficulties alluded to regarding “sham” surgery. It’s tough to get people to sign up for something like that. You’ll also inherently get a patient population more genuinely open to all alternatives. Many orthopedic surgeons routinely use data like this to counsel patients about the efficacy of meniscectomy in arthritic knees, which in good trials is almost always not better than PT at mid-term outcomes. The surgery is effective at relieving mechanical symptoms (popping and clicking), but we know removing meniscus leads to degenerative changes, so it’s almost intuitive that the surgical arm had higher progression of degenerative changes. The balance is the competing goals of short term symptomatic relief versus the long term risk of arthritis when unstable meniscal tears are “cleaned out.” Part of the issue is the culture around orthopedic surgery, both with surgeons who like operating and can rationalize these surgeries because they have patients who are helped by them (and it helps the surgeons because productivity is usually tied in some way to reimbursement), and also patients who think that orthopedic surgery is a cure-all and aren’t willing to do things like shed some weight or actually commit to a therapy regimen.
AMEN!!!! The power of the mind (placebo) or an invasive potential harmful procedure. More people need to be aware of this. Loved the Sham-controlled trials that reversed common practice table
Superb as usual. And congratulations to physicians who do procedures who are willing to question what they do - design the appropriate trial with the appropriate "control" group - potentially changing practice.
What's most important is what's omitted from the essay. Surgery for a senile worn thin and fragmenting meniscus is dubious and problematic. For a healthy meniscus which has suffered a bucket handle tear and is intermittently jamming the knee surgery is the only means of treatment and is highly successful (I'm 36 years on my post op L medial meniscus). In my IM/rheum career I referred all with a torn and jamming meniscus but probably none with friable worn thin menisci lacking a single remediable lesion.
The podcast Hidden Brain did an episode 6 years ago that mentioned equivalent outcomes between placebo treatment and arthroscopic knee surgery. NEJM published the study discussed in the podcast 24 years ago! Moseley JB et al., "A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee," NEJM 347, 2: 81–88, DOI: 10.1056/NEJMoa013259.
I wonder how frequently this surgical procedure gets performed today.
Regarding the ethics of placebo-controlled surgical trials, I’m generally comfortable with them when true equipoise exists and a sham control is necessary to answer the question.
And it’s always possible that patients in the placebo arm may actually end up better off. That seems to be what we’re seeing here—84% of patients in the placebo arm were still satisfied at 10 years.
The key, of course, is that the risks of the sham procedure are minimized and clearly understood, since the ethical bar is understandably higher than in most drug trials.
These participants and researchers have done an enormous service to future patients.
Can we drop statements such as "was significant" or "was not significant"? These are almost meaningless. Replace them with confidence intervals for the difference.
I trained with Franz Halberg at the University of Minnesota back when God was a baby, and I'm certain Franz would agree with your perspective on placebo procedures.
The single health care system in Denmark may make it easier to do clinical trials, as it's easier to recruit patients and follow them up. I did a story a few years ago about clinical trials of rare diseases, and Denmark can pool its patients with countries like Australia and the UK etc, but it's hard with the US because of different insurance pathways and legal liability etc.
Just a quick comment about the tag line, the arthroscopic partial meniscectomy described in the study is not a “meniscus repair,” which would be a procedure that attempts to preserve and not remove meniscus (shown to lead to higher rates of arthritis). Orthopedic literature across the board is pretty weak for the difficulties alluded to regarding “sham” surgery. It’s tough to get people to sign up for something like that. You’ll also inherently get a patient population more genuinely open to all alternatives. Many orthopedic surgeons routinely use data like this to counsel patients about the efficacy of meniscectomy in arthritic knees, which in good trials is almost always not better than PT at mid-term outcomes. The surgery is effective at relieving mechanical symptoms (popping and clicking), but we know removing meniscus leads to degenerative changes, so it’s almost intuitive that the surgical arm had higher progression of degenerative changes. The balance is the competing goals of short term symptomatic relief versus the long term risk of arthritis when unstable meniscal tears are “cleaned out.” Part of the issue is the culture around orthopedic surgery, both with surgeons who like operating and can rationalize these surgeries because they have patients who are helped by them (and it helps the surgeons because productivity is usually tied in some way to reimbursement), and also patients who think that orthopedic surgery is a cure-all and aren’t willing to do things like shed some weight or actually commit to a therapy regimen.
AMEN!!!! The power of the mind (placebo) or an invasive potential harmful procedure. More people need to be aware of this. Loved the Sham-controlled trials that reversed common practice table
Thank you for helping patients know when they really need a surgical procedure or not and gain the confidence to "dig deeper" .
Superb as usual. And congratulations to physicians who do procedures who are willing to question what they do - design the appropriate trial with the appropriate "control" group - potentially changing practice.
Most of the medical therapies are placebos and the most efficacious of placebos/therapies is time spent with patients.
What's most important is what's omitted from the essay. Surgery for a senile worn thin and fragmenting meniscus is dubious and problematic. For a healthy meniscus which has suffered a bucket handle tear and is intermittently jamming the knee surgery is the only means of treatment and is highly successful (I'm 36 years on my post op L medial meniscus). In my IM/rheum career I referred all with a torn and jamming meniscus but probably none with friable worn thin menisci lacking a single remediable lesion.
The reason it doesn't happen much in the US is that you RARELY meet a surgeon that doesn't stake their total MD ability on CUTTING.
The podcast Hidden Brain did an episode 6 years ago that mentioned equivalent outcomes between placebo treatment and arthroscopic knee surgery. NEJM published the study discussed in the podcast 24 years ago! Moseley JB et al., "A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee," NEJM 347, 2: 81–88, DOI: 10.1056/NEJMoa013259.
I wonder how frequently this surgical procedure gets performed today.
Great article. Thank you.
Some confusion, the patella is not related to arms as far as I know. ???
Great post as always!
Regarding the ethics of placebo-controlled surgical trials, I’m generally comfortable with them when true equipoise exists and a sham control is necessary to answer the question.
And it’s always possible that patients in the placebo arm may actually end up better off. That seems to be what we’re seeing here—84% of patients in the placebo arm were still satisfied at 10 years.
The key, of course, is that the risks of the sham procedure are minimized and clearly understood, since the ethical bar is understandably higher than in most drug trials.
These participants and researchers have done an enormous service to future patients.
We wrote an article about the "math of the ethics" if you're interested.
https://drive.google.com/file/d/1IB0xymNYozUuFwOLcB8iA7n5K4y6YfJ0/view
Can we drop statements such as "was significant" or "was not significant"? These are almost meaningless. Replace them with confidence intervals for the difference.
I trained with Franz Halberg at the University of Minnesota back when God was a baby, and I'm certain Franz would agree with your perspective on placebo procedures.