New Surgical Technologies: When Does Innovation Mean Improvement?

H. Gene Dossett, MD, MBA Editorial Advisory Association Member New Surgical Technologies: When Does Innovation Mean Improvement?

n the weeks and days leading became apparent that this device had electronic gadget, we have better tools up to Steve Jobs’s January 27 an unintended long-term effect— for evaluating new surgical technol- announcement about the new namely, the erosion of the nearby ogy. The best way to test the effective- IApple iPad tablet computer, ex- aorta, which in a few cases caused it to ness and safety of such technology is citement over the anticipated product rupture resulting in the sudden death to construct a prospective, double- launch was running at a fever pitch. of the patient. Needless to say, the blind, randomized, controlled trial With Apple’s past innovations in- device is no longer on the market, and (also known as level I research). In cluding the Macintosh computer, the the patients who received the device this type of research, both the random iPod, and the iPhone, many expected have had it removed. assignment of patients to treatment Jobs to introduce another trend set- A more recent example of an inno- groups and the blinding of patients ting, lifestyle changing product. Few vation in knee surgery is minimally and investigators to which treatment of us remember that, in addition to invasive total knee replacement. No they are receiving help avoid bias and some amazing successes, Apple has one wants maximally invasive sur- produce reliable data. also released some flops, such as the gery, so the name alone suggests an Notably, however, many new Cyberdog, Newton, Macintosh TV, improvement. After this new tech- orthopedic products have not been iPod HiFi, Pippin, and eWorld. Only nique was introduced, many patients subjected to level I research before time will tell where on that spectrum came to my office, article in hand, being released and marketed to sur- the iPad will fall, but already many asking if I performed this type of surgeons and patients. In recent years, technology reviewers have expressed gery. Most orthopedic surgeons would level I articles have composed 11.3%1 disappointment with the iPad and its admit that performing an operation to 21%2 of the clinical research arti- capabilities. Personally, I will reserve through a small incision can be a cles published in leading orthopedic my judgment until I thoroughly eval- struggle; a larger incision makes it journals. While these numbers rep- uate the device—by reading expert easier to see and align the implants. resent an improvement over decades reviews and trying it out for myself. Since the patients only see the scar, past,2 they are still lower than ideal. Just as we consumers tend to think smaller looks better to them. The Researchers are being encouraged to that the next electronic innovation goal of the procedure, however, is the design studies that meet this higher must be an improvement over what proper implantation of a knee pros- level of evidence. we currently have, many patients thesis designed to last many years, At my institution, my colleagues believe that innovation in surgery pre- and if a larger incision helps accom- and I are currently performing a level dictably produces something better. plish this goal more effectively, many I research study to determine whether Open heart surgery; kidney trans- experts now agree that a slightly lon- a new method of placing total knee plants; reimplantation of severed fin- ger scar is an acceptable consequence. implants is better than the conven- gers; and hip, knee, and shoulder Capitalizing on the common belief tional method we have used for more replacements are just a few of the that newer is better, manufactur- than 20 years. The new method aligns surgical innovations that have worked ers market new products directly to the implants “kinematically”—that is, out well and improved the lives of our patients to increase sales, often before along the axes of the knee—with the patients. evidence has demonstrated that the goal of allowing the knee to move But surgery’s track record, much new product is better. At times, we more normally than is possible with like Apple’s, is not perfect. A number surgeons respond to this patient the conventional method. It relies of years ago, surgeons began using demand and start using new tech- on proprietary software (OtisMed, a new fixation device to stabilize nologies before we know for sure they Alameda, CA) that uses magnetic res- the anterior spine. The early results are superior. onance images of the patient’s knee to looked promising, so more and more Fortunately, compared with how generate a three-dimensional model devices were used. After a while, it consumers must evaluate the latest of the knee. Based on this model, the

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8 • FEDERAL PRACTITIONER • MARCH 2010 EDITORIAL

Continued from page 8 program selects the best sized implant veloped and are now marketing Disclaimer for each bone and places the implant their own patient-specific cutting The opinions expressed herein are those so that the kinematics of the knee guides to patients and surgeons. Al- of the author and do not necessarily are reproduced. The computer then though these guides appear similar to reflect those of Federal Practitioner, machines the patient-specific cutting the ones we are testing, they use the Quadrant HealthCom Inc., the U.S. guide from plastic, allowing the sur- principle of mechanical rather than government, or any of its agencies. geon to transfer the position of the kinematic alignment, so the theory This article may discuss unlabeled or knee implants from the computer to behind them is different. Only care- investigational use of certain drugs. the patient in surgery.3 fully constructed, double-blind, pro- Please review complete prescribing The newer method is faster, spective, randomized, clinical trials information for specific drugs or drug requires only one eighth of the surgi- can determine whether one method combinations—including indications, cal equipment currently used, and is for implanting a total knee replace- contraindications, warnings, and uniquely designed for each individual ment is better than another. adverse effects—before administering patient. Its potential benefits include a Given the past marketing strategies pharmacologic therapy to patients. more rapid recovery and better clini- of our industry, the coming year likely cal outcomes. But is it better? We will see more dollars spent trying to References 1. Obremskey WT, Pappas N, Attallah-Wasif E, won’t really know until we complete convince patients and surgeons that Tornetta P III, Bhandari M. Level of evidence the study and analyze the outcomes. one system is better than another. in orthopaedic journals. J Bone Joint Surg Am. 2005;87(12):2632–2638. Then we will need to submit our Rather than simply responding to 2. Hanzlik S, Mahabir RC, Baynosa RC, Khiabani KT. work to a peer-reviewed journal for an marketing, we need to carefully evalu- Levels of evidence in research published in The Journal of Bone and Joint Surgery (American Volume) independent review and publication. ate results from well designed, level I over the last thirty years. J Bone Joint Surg Am. Once our study is published, other studies to determine what is best for 2009;91(2):425–428. 3. Custom Fit Knee Replacement. OtisMed web site. surgeons can review the methods, our patients. ● http://otismed.com/about.html. Accessed February data, and analysis to help them decide 24, 2010. whether they would like to use the Author disclosures new technology. The author reports no actual or poten- Since we began this research two tial conflicts of interest with regard to years ago, other companies have de- this editorial.

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