Vertebroplasty and knee arthroscopy: two interventions questioned by the evidence

@varelalaf

The measurement of the clinical effectiveness of surgical interventions is, regrettably, not too frequent. In this field, the design of rigorously and well executed clinical trials has its complexities, especially when the control group undergoes sham surgery. For this reason, it’s worth disseminating the conclusions of consistent studies that arouse doubts about the effectiveness of the decisions made every year by the operating rooms to thousands of citizens, who must accept the risks, not negligible, inherent in surgical intervention. In this regard, I already mentioned the poor results that a clinical trial had shown for coronary angioplasties with stenting in patients with stable angina and, in the same vein, today I have selected two clinical trials related to orthopaedic interventions.

Vertebroplasties

A multicenter clinical trial, Investigational Vertebroplasty Safety and Efficacy Trial (INVEST), with sham surgery was carried out in the US, UK and Australia with 131 selected people suffering from vertebral fractures of osteoporotic origin with compression, which, evidently, were painful. The 63 patients in the control group underwent exactly the same surgical protocol as in the intervention group, except that in these the needle did not inoculate the cement. According to the authors, the simulation was very true and even the surgeon opened the pouch of methacrylate so that the patient could smell the cement. The conclusions of the study say that, within a month of the intervention, improvements in pain, functional limitations and quality of life were comparable in the two groups of patients.

Knee arthroscopies

A clinical trial carried out in two Norwegian public hospitals collected 140 people with an average age of 49.5 years and a range of 35.7 to 59.9, who suffered a meniscus tear of the degenerative type verified by magnetic resonance without radiographic evidence of osteoarthritis. Half of the patients underwent meniscectomy and the other half entered a 12-month physiotherapy program. In this case there was no false surgery, the patients knew, therefore, whether they had gone through surgery or not. However, after two years, the evaluation performed with blind techniques did not show that the people who were operated on had less pain, more functional capacity, or more quality of life than those of the group that had exclusively followed the rehabilitation program. The Norwegian researchers suggest, therefore, that in the event of a ruptured meniscus, physiotherapy is a competitive therapeutic alternative, especially when taking into account that the patient avoids the risks of surgery.

What do the Iasist databases say?

Iasist's new orientation towards right care has made it easier for me to know the reality of the 183 Spanish hospitals (public and private) that participate in their databases in relation to the two subjects studied. As for vertebroplasties, in the 2015 data, six years after the publication of the results of the clinical trial, the tracking shows that 1,355 people intervened, giving the eventuality of a public teaching hospital with a record of 256 interventions. As for knee arthroscopies, the number of operations observed, also in 2015, was very high, 32,239. In this case, it must be recognized that the Norwegian clinical trial was published a year later, in 2016. We hope, therefore, that subsequent analyzes will include an expected surgical reduction and an increase in rehabilitation.

When a technique, especially if it’s surgical, has obtained its fame through logical arguments: if a piece is broken it sticks with cement, if a piece is torn it’s removed, even if the evidence contributes with consistent studies of lack of effectiveness, the need for reversion, to the patients’ ears may sound like a cut. As Vinay Prasad says, this evil should be addressed in the beginning, preventing surgical techniques from being approved without having proven them with the same rigor that is required of drugs.