Report from ArgoSpine: Surgeon Insight into Clinical Evidence, Device Preference and New Technologies
BY ELOISE AUSTIN, FEBRUARY 12, 2008
Recently ArgoSpine held its 12th annual symposium, gathering top spine surgeons from around the globe to discuss the latest technologies and treatment practices. This conference focused on complications in spinal surgery, paying special attention to vascular and nervous system damage, as well as infections and tumor recurrence. Below are some of the themes that emerged over the course of the two-day conference and the repeated points of debate during the post-lecture discussions.
“The Long Tail” phenomenon: Like “the long tail” principle in statistics and business strategy, it appears that there is a wide range of device preferences across the majority of the surgeon population. The surgeons in the audience and at the podium expressed preferences for a range of surgical methods and technologies within a given surgical case. There was often no consensus on the best intervention or specific kinds of instrumentation or approach (for example, anterior vs. posterior approach in fusion) to use. Surgeon practices in spinal surgery appear to vary by institution and region, shaped by the opinion leaders in the field - and because of the shortage of long-term clinical trials in this field, there is no absolute consensus on best practices. The take-away point may be that companies in this field can best respond to surgeons’ needs by offering diversified lines of products to match the diversity of methods employed by most spine surgeons.
The necessity of employing n=1 evidence in rare clinical cases: The cases discussed highlighted the fact that many spine surgery cases, even those of common disorders, are surrounded by singular or rare circumstances. No two cases of degenerative spine disease or disc herniation are exactly alike in terms of anatomy or the host/patient environment. Throughout the conference, surgeons brought up only one or two previous cases that supported their rationale for a particular surgical strategy - rarely quoting statistics. For the industry, this observation suggests that communicating with surgeons may need to involve a more case-based approach - on the other hand, well-designed clinical trials demonstrating the efficacy of a medical device would likely be more powerful in this field, with its current shortage of clinical evidence.
Frustration with the throw-everything-but-the-kitchen-sink-at-the-problem method: Since the conference focused on complications, many of the cases involved multiple procedures with increasing degrees of invasiveness and instrumentation. During the discussions, there was some frustration expressed over this approach—and many argued for either conservative management or more minimally invasive approaches where possible. The take-away in this case is that the industry should continue moving to develop minimally invasive techniques.
Preference for simplicity in clinical tools: Amid discussion of complex procedures and a multitude of new technologies, many surgeons indicated an inclination toward simplicity in both procedures and instrumentation. Surgeons voiced hesitation about using new technology that requires a complex set of steps or combination of instruments. “Simple is better” was a mantra repeated multiple times. For companies manufacturing spine instruments, this means they should aim to create devices that are very user-friendly and simple in design, which would lower barriers to adoption.
Visuals: As indicated by the presentations, surgery is a very visual field - there is a need for visual instruction demonstrating anatomic placement of a device, a dependence on radiographic images to guide pre-operative planning, and the use of computer models to demonstrate biomechanical properties of devices. It is obvious that visuals are a key component of presentations of spinal instrumentation in marketing. And 3-D visuals have the potential to play a large role pre- and intraoperatively, via radiographic navigation systems.
