Over the past several decades, orthopaedic surgery has enjoyed an explosion in the development of new technologies. These technologies have largely improved the quality of orthopaedic care. The development of new technologies results in both disruptive and nondisruptive evolution and requires that orthopaedic surgeons gain specific knowledge of their appropriate use in clinical practice.
However, despite the advances developed from orthopaedic innovation, many discoveries have been associated with unanticipated adverse events. As an example, the original total hip replacement developed by Charnley featured a 1-piece femoral component with a 22.5-mm head. This was later changed to a larger-diameter head, resulting in increased volumetric wear of conventional polyethylene. In addition, new implants with sharp corners led to cement fractures and the development of so-called cement disease. More recently, metal-on-metal articulations have been associated with metallic particles and ion-induced bone and soft-tissue destruction. Ceramic-on-ceramic articulations may lead to implant breakage, striped wear, and squeaking. There is no question that total hip arthroplasty is an exceptionally successful technology, but there is concern regarding the way in which improvements and innovations gain regulatory approval and surgeon acceptance.
In the May 2016 issue of JBJS Reviews, Goodman et al. discuss the introduction of new technologies in orthopaedic surgery. They review the use of novel biologics and combination products and, in particular, single out platelet-rich plasma for the insufficient clinical evidence to support its use. Moreover, they describe the initial enthusiasm regarding the use of recombinant human BMP-2 for spine fusions but note that a review of clinical trials has revealed that there may be concerns regarding insufficient numbers of patients to assess safety, under-reporting of serious complications, conflict of interest among the investigators, and potential bias.
Goodman et al. address some very simple but nonetheless profound issues. For example, they ask, “How should new technologies be introduced into orthopaedics?” They further ask, “How should a surgeon learn to use new technology?” Perhaps most importantly, they raise the issue of ethical considerations related to the use of new technology.
The future of orthopaedic innovation looks bright. Some have commented that there are too many perceived barriers to gaining regulatory approval of new technologies. Recently, the structure and methodology by which approval of new medical technology is managed across the United States has come under increased scrutiny.
I do not think you can ever be too safe or too careful. This article by Goodman et al. is an excellent review of the issues and considerations. It’s a quick read but leaves plenty of room for thought!
Thomas Einhorn, Editor