Surgical “Placebo” Controls

OBJECTIVE: To set ethical guidelines on the use of surgical placebo controls in the design of surgical trials. BACKGROUND DATA: Ethical concerns recently arose from surgical trials where subjects in the control arm underwent surgical procedures that had the appearance of a therapeutic intervention, but during which the essential therapeutic maneuver was omitted. Although there are ethical guidelines on the use of a placebo in drug trials, little attention has been paid to the use of a surgical placebo control in surgical trials. METHODS: The Council on Ethical and Judicial Affairs developed ethical guidelines based on a wide literature search and consultation with experts. RESULTS: Surgical placebo controls should be limited to studies of new surgical procedures aimed at treating diseases that are not amenable to other surgical therapies, and are reasonably anticipated to be susceptible to substantial placebo effects. If the standard nonsurgical treatment is efficacious and acceptable to the patient, then it must be offered as part of the study design. CONCLUSIONS: Surgical placebo controls should be used only when no other trial design will yield the requisite data and should always be accompanied by a rigorous informed consent process and a careful consideration of the related risks and benefits. The recommended ethical guidelines were adopted as AMA ethics policy and are now incorporated in the AMA's Code of Medical Ethics.     

A case of “acquired” cor triatriatum

Cor triatriatum sinister is a rare congenital cardiac anomaly. It consists of a fibro-muscular membrane that separates the left atrium into two chambers resulting in a tri-atrial heart. It is often found in association with other structural cardiac anomalies. The “acquired” form is extremely rare and only anecdotal reports are found in literature. We describe a case of acquired cor triatriatum following surgical repair of coronary sinus type of total anomalous pulmonary venous connection (TAPVC), which presented 11 years after initial repair of TAPVC.     

Clinical Comparison of the “Windowing” Technique and the “Open Book” Technique in Schatzker Type II Tibial Plateau Fracture

ObjectiveSurgical treatment for Schatzker type II tibial plateau fractures remains challenging and requires high‐quality research. The aim of the study is to compare the “windowing” and “open book” techniques for the treatment of Schatzker type II tibial plateau fractures.MethodsIn this prospective study, all patients with Schatzker type II tibial plateau fractures between January 2014 and December 2017 were managed by open reduction and internal fixation using an anterolateral incision approach. “Windowing” group included 78 patients (53 men and 25 women), with an average age of 57.7 ± 13.5 years, who underwent the “windowing” technique, in which the procedure was performed through a small cortical window against the depressed zone of the lateral plateau. The “open book” group included 80 patients (56 men and 24 women), with an average age of 54.8 ± 12.4 years, who underwent the technique. The clinical outcomes included the Rasmussen classification of knee function and grading of post‐traumatic arthritis. The radiographic outcome (x‐ray and computed tomography [CT]) was the reduction quality of the lateral plateau based on the modified Rasmussen radiological assessment. The patient‐reported outcome was visual analogue scale (VAS) scores.ResultsThe mean follow‐up time for the158 patients was 32 months (range, 24–42 months). The time elapsed from injury to surgery in “windowing” group and “open book” group were 3.7 ± 1.2 (range, 1–10 days) and 3.5 ± 1.4 days (range, 1–11 days), respectively, with no significant difference between the groups (P > 0.05). The operation times did not differ significantly between the “windowing” group (61.0 ± 8.3 min, range, 45–120 min) and the “open book” group (61.2 ± 10.4 min, range, 40–123 min) (P > 0.05). After surgery, CT revealed five (6.4%) and 15 (18.8%) cases of articular depression in the “windowing” and “open book” groups, respectively. Significant differences were observed in the articular depression of tibial plateau fractures between the groups (P < 0.05). However, condylar widening or valgus/varus did not differ significantly between the groups. Furthermore, no significant differences in knee function were observed during follow‐up (P > 0.05). VAS scores were similar between the groups at 24 months after surgery (P > 0.05). There were significant differences in the number of severe post‐traumatic arthritis (grades 2 and 3) cases between the groups (P < 0.05).ConclusionsThe “windowing” and “open book” techniques are both effective for the treatment of Schatzker type II tibial plateau fractures. However, the “windowing” technique provides better reduction quality, leading to a satisfactory prognosis.