In Brief: OrthoLogic
This article was originally published in The Gray Sheet
Executive Summary
OrthoLogic: Expanding patient enrollment in clinical trials of the OrthoLogic 1000 bone growth stimulator "to establish conclusive statistical significance" of the device's effectiveness in treating delayed union fractures, the company says. Results from the first 106 fractures showed that 62.5 % of the patients with OrthoLogic 1000 devices healed as opposed to 55.2% of the subjects that received placebo devices. While the data obtained from the study shows a positive effect, "the healing rate in the placebo group was greater than originally anticipated," according to an OrthoLogic press release. OrthoLogic received PMA approval for the product to treat nonunion fractures in March of 1994 ("The Gray Sheet" March 14, 1994, p. 4). ..