Bravery (and Humility) is Needed to do Proper Medical Science: 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. (John Mandrola, May 04, 2026, Sensible Medicine)
First was a diagnostic arthroscopy. Then randomization. Active arm surgery included removal of all loose, weak fragments as well as unstable meniscus with preservation of as much of the meniscus as possible.
For the sham surgery, a standard arthroscopic partial meniscectomy was simulated. To mimic the sensations and sounds of a true arthroscopic partial meniscectomy, the surgeon asked for all instruments, manipulated the knee as if an arthroscopic partial meniscectomy was being performed, pushed a mechanized shaver (without the blade) firmly against the patella (outside the knee), and used suction. The patient was also kept in the operating room for the amount of time required to perform an actual arthroscopic partial meniscectomy.
Outcomes were three pain scores. Their names aren’t critical. But all three were not statistically different. Critically, patients could not identify their treatment arm; blinding had worked.
In the 10-year radiological assessment. 81% of the patients in the operative arm had progressed to have arthritis vs 70% in the placebo arm. This barely missed statistical significance. More patients in the placebo arm reported satisfaction (84% vs 75%). More patients in the surgery arm progressed to high tibial osteotomy or total knee replacement (12% vs 4%).
The first thing that pops in my head is: what if these researchers (and patients) were not so bold. An ineffective procedure would have remained popular, with costs into the billions, and if the trends in this study are true, increasing numbers of people would progress to knee replacement. AKA: harm.