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February 09, 2017
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Put new technology into practice, but understand true outcomes

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In August 2016, Seth Maness, a Major League Baseball relief pitcher, underwent a repair and augmentation of his injured ulnar collateral ligament of his elbow.

In his operation, the addition of synthetic material to ulnar collateral ligament repair was a deviation from previous successful repair techniques.

After the surgery, the media noted the new approach could make Tommy John surgery “a thing of the past.” Other comments regarded Maness as a “trailblazer” as the surgery remains experimental, although, the surgeon stated he has performed 50 repair-like procedures in the past and all have been successful. The procedure was performed with expectation that Maness’ recovery time would be half that of ulnar collateral ligament (UCL) reconstructions, therefore, he would be able to return to throwing next season.

Anthony A. Romeo

Maness’ surgery could be regarded as an experiment as orthopedic surgeons have no specific data to correlate to this type of patient and surgery that included the synthetic augmentation. However, the original UCL reconstruction surgery performed on Tommy John in 1974 was also regarded as an experiment.

New technology, ideas

The introduction of reportedly successful new technology and ideas that solve problems in patient care is seductive to orthopedic surgeons. We want to help patients and we want to offer the most advanced treatments possible. New ideas are attractive when surgeons already have the skill set to accomplish the procedure with little additional training or instruction.

When the public is presented with new ideas about how to solve well-recognized medical or surgical problems, the impact is seen by physicians. Patients want to know about the procedure. In the court of public opinion, they are convinced new operations that not only work as well as or better than older methods but also reduce time away from sport or work, must be better. If their surgeon does not know how to perform the procedure, then patients often seek advice from other surgeons. When discussing new procedures, expected outcomes and possible complications, less experienced surgeons will often quote results and outcomes of the surgeons who developed the technique, assuming results will be the same in their hands.

The possibility of a surgery that is as effective, easier to perform, has reduced rehabilitation time and is always successful can be too much to resist, even if peer-reviewed studies with appropriate long-term follow-up are lacking. Peer review allows for the assessment of the quality of the investigation by impartial reviewers, accuracy of data and methods and conclusions. Frequently, when authors initially present their undocumented experience, they overestimate the number of patients who make up the group to be analyzed. As researchers create inclusion and exclusion criteria, the number of cases is often decreased by as much as 30% or more. This number may be further reduced when the peer-review process is applied. Likewise, media presentation of a new idea or technique can overstate its value or understate potential complications.

Rise and fall of surgical techniques

In 2001, a British gynecologist, J.W. Scott, MD, published in the British Medical Journal a paper entitled “Scott’s parabola: The rise and fall of a surgical technique.” The parabola begins with a promising idea. Then there are early reports, usually focusing on the technique and not outcomes, to stimulate interest. The number of procedures begins to increase substantially. Then, enthusiasm grows among surgeons and the media picks up the story, sharing anecdotal and often inaccurate but highly supportive information with the public.

The number of procedures continues to grow substantially, and may even become perceived as the standard of care. Reports then begin to surface about failure, as well as other complications as outcomes are never 100% successful, thereby creating doubt in the procedure.

Currently, we are on the first part of Scott’s parabola about the repair and internal bracing of symptomatic UCL deficiency. It is likely we will have a dramatic increase in the use of this procedure. It is imperative that we are responsible to the science of this treatment and carefully define the best patients. Even this step is controversial, as often UCL repair or reconstruction is offered to young athletes who have medial elbow pain during the throwing motion as their primary indication for treatment. Laxity criteria are not well defined nor consistently evaluated. MRI findings are not prognostic at this time. Essentially, any pitcher who has medial elbow pain is a potential candidate for this new procedure. The potential for overuse, and to some degree abuse, is high due to unrealistic expectations of adolescent throwing athletes — patients who are undergoing an epidemic of UCL reconstructions.

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The phenomenon of Scott’s parabola has been applied in other examples of new technology and innovation in orthopedics, including metal-on-metal hips, thermal shrinkage, intra-articular pain pumps, spinal bone grafting, distal radius plate system and bioabsorable tacks for labral fixation in the shoulder among many others. As our primary goal is to provide the best care for patients, we need to be aware of new ideas and technologies that may improve our abilities to provide successful outcomes.

If we are going to introduce new technology into practice, then we should be advocates for patients by defining clear inclusion criteria, advancing surgical skill and carefully following patients to understand the true outcomes achieved by the new innovations in our own hands. We should not rely on media reports, anecdotal experiences, unproven surgical technique papers or videos or publicly reported results that have not been peer reviewed.

Disclosure: Romeo reports he receives royalties, is on the speaker’s bureau and a consultant for Arthrex; does contracted research for Arthrex and DJO Surgical; receives institutional grants from AANA and MLB; and receives institutional research support from Arthrex, Ossur, Smith & Nephew, ConMed Linvatec, Athletico and Miomed.