Sometimes, I wonder if orthopaedics is a branch of modern medicine at all. While large, multicenter RCTs are common practice in other fields, in orthopaedics, we seem to rely on mechanical reasoning, biological plausibility, and uncontrolled before-after studies. This duality has become very visible with regard to orthopaedic sham-controlled trials.
A recent research in the Arthroscopy Journals provides a great example. The subacromial spacer (InSpace) is a device that was developed to treat irreparable rotator cuff tears. Usually, it results in the cranialization of the humeral head. A great biologically plausible theory suggests that the spacer presses the humeral head downward, thus helping a patient with such a tear.
Two trials have concluded that the device is low-value care for our patients. The first study was published in the Lancet. This was a robust, adaptive trial, stopped early for futility. The authors concluded, “We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears.”
Another recent study was a industry-funded trial. They compared the spacer to partial cuff repair. The spacer did not provide any clear benefit over partial repair, although with selective reporting, the authors mentioned some benefits for the spacer. The authors concluded, “…the outcomes of the InSpace implant were comparable with those of partial repair…” That is surely a way to frame disappointing results.
A recent study published in the Arthroscopy journal reported positive effects of the spacer device, of course, in an uncontrolled, before-after setting. The authors discussed the Lancet study: “Heterogeneity factors included undisclosed rehabilitation protocols, variable formal rehabilitation usage, virtual follow-ups, and differing patient demographics. Caution in interpreting study results was advised due to these concerns.”
I am quite confident that virtual follow-ups do not modify the treatment towards inefficacy. This is the Nth example when my colleagues have a hard time accepting that a fancy surgical treatment may be without any benefit. The response to other sham or actively controlled studies has been the same: wrong patients, wrong outcomes, incapable surgeons, wrong follow-up, etc. Sure, it is hard to acknowledge that something you believed in before is actually not beneficial. The fierce objection to high-quality trials among my colleagues is not good for our patients. Our patients deserve treatment based on the highest quality evidence. And this is exactly what sham and actively controlled trials provide. We need to adjust our prior beliefs based on new evidence and set aside financial incentives, especially. That is to the advantage of our patients.
