Orthopedic surgeons are barraged, virtually on a daily basis, with information concerning new technologies; this may include different implants, instrumentation and surgical techniques, local and systemic biological therapies, and other devices. This information originates from numerous sources and stakeholders, including journal and media advertisements, device manufacturers, conferences, medical associations, payers, government agencies, hospitals, colleagues, and patients.1 Indeed, direct-to-patient advertising has already altered the conversation between surgeons and patients. Patients commonly arrive in clinic with preconceived ideas (and comments such as, “I have done my research and . . . .”) regarding what they want done at surgery, the surgical approach, and their specific choice of implant. Whereas a robust conversation between surgeon and patient may foster an engaging two-way decision-making process, patients often are confused and misinformed by material they have seen or gathered.2,3 Furthermore, to remain relevant and viable in a highly competitive marketplace, surgeons may feel pressured into adopting new technologies requested by patients or presented by implant representatives.
The above discussion begs the more general question: How should new technologies be introduced into orthopedic practice? This subject continues to generate much discussion, given ongoing proposed changes in our health care system, constant emphasis on the practice of evidence-based, cost-effective medicine, and the realization that some new technologies have had questionable or, in some cases, negative consequences.4–6 Some examples include metal-on-metal total hip arthroplasty, excessive modularity of implants, computer-assisted surgery, and the use of BMP-2 and platelet-rich plasma.7–13 These technologies all have their proponents and detractors. How is the practicing orthopedic surgeon able to judge all this information and make sensible decisions?
There is no question that we have seen some spectacularly successful innovations in orthopedics and related specialties in recent years. Some of these include cephalomedullary and locked intramedullary nails, modern spinal instrumentation, highly cross-linked polyethylene in total hip arthroplasty, multi-modal control of pain, and disease-modifying anti-rheumatic drugs. Other innovations, still on the horizon, may have remarkable, even paradigm-changing potential to alter how we practice orthopedics. Some of these include biological engineering of musculoskeletal tissues, robotics, 3-dimensional printing technologies, and nanoantibiotics.14–19
Several research groups and committees have provided sage insight into how we should think of introducing new technologies into surgical specialties and into orthopedics in particular.5,20,21 The “innovation cycle” has many stakeholders with a vested interest in the safety, efficacy, and cost-effectiveness of introducing a new product into surgical practice.1,22 Almost 25 years ago, Professor Rik Huiskes23 emphasized that it is the surgeon who should take a clear leadership role and responsibility to systematically review the preclinical data (biomechanical, computational, biological, animal studies, and so on) and clinical trials prior to introducing any new technology for use in patients. Once the preclinical and regulatory criteria are met, a stepwise introduction of new technologies, on a limited basis, to high-volume clinical centers with the appropriate infrastructure for detailed analysis of outcomes follows logically.24–26 Ongoing postmarket analysis and surveillance measures using databases and registries are important tools to help ensure that implants and biologics function appropriately, without adverse consequences.21,24–26 Partnerships that include all relevant parties must be developed so that new technologies can be introduced to hospitals and surgeons, who become suitably trained in the safe and effective use of these new tools.27 Potential bias and conflicts of interest must be transparent and recognized.28–30
All participants interested in technological innovation in orthopedics must continue to place patients' interests first and foremost.31 Surgeons must have the trust and confidence of their patients, who depend on surgeons to practice their profession with the highest degree of knowledge, integrity, and compassion. The safe, efficacious, and cost-effective use of novel devices and biologics furthers this important goal.
- de Ana FJ, Umstead KA, Phillips GJ, Conner CP. Value driven innovation in medical device design: a process for balancing stakeholder voices. Ann Biomed Eng. 2013; 41(9):1811–1821. doi:10.1007/s10439-013-0779-5 [CrossRef]
- Bozic KJ, Smith AR, Hariri S, et al. The 2007 ABJS Marshall Urist Award. The impact of direct-to-consumer advertising in orthopaedics. Clin Orthop Relat Res. 2007; 458:202–219.
- Adeoye S, Bozic KJ. Direct to consumer advertising in healthcare: history, benefits, and concerns. Clin Orthop Relat Res. 2007; 457:96–104.
- Nieuwenhuijse MJ, Nelissen RG, Schoones JW, Sedrakyan A. Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies. BMJ. 2014; 349:5133. doi:10.1136/bmj.g5133 [CrossRef]
- Goodman SB, Mihalko W, Anderson P, Sale K, Bozic K. Introduction of new technologies in orthopaedic surgery. JBJS Rev. 2016; 4(5):e5, 1–7. doi:10.2106/JBJS.RVW.O.00067 [CrossRef]
- Burnham JM, Meta F, Lizzio V, Makhni EC, Bozic KJ. Technology assessment and cost-effectiveness in orthopedics: how to measure outcomes and deliver value in a constantly changing healthcare environment. Curr Rev Musculoskelet Med. 2017; 10(2):233–239. doi:10.1007/s12178-017-9407-6 [CrossRef]
- Dunbar MJ, Prasad V, Weerts B, Richardson G. Metal-on-metal hip surface replacement: the routine use is not justified. Bone Joint J. 2014; 96-B(11)(suppl A):17–21. doi:10.1302/0301-620X.96B11.34426 [CrossRef]
- Esposito CI, Wright TM, Goodman SB, Berry DJClinical, Biological and Bioengineering Study Groups from Carl T. Brighton Workshop. What is the trouble with trunnions?Clin Orthop Relat Res. 2014; 472(12):3652–3658. doi:10.1007/s11999-014-3746-z [CrossRef]
- Hsu WK, Mishra A, Rodeo SR, et al. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2013; 21(12):739–748.
- Shulman RM, Zywiel MG, Gandhi R, Davey JR, Salonen DC. Trunnionosis: the latest culprit in adverse reactions to metal debris following hip arthroplasty. Skeletal Radiol.2015; 44(3):433–440. doi:10.1007/s00256-014-1978-3 [CrossRef]
- Ong KL, Villarraga ML, Lau E, Carreon LY, Kurtz SM, Glassman SD. Off-label use of bone morphogenetic proteins in the United States using administrative data. Spine (Phila Pa 1976). 2010; 35(19):1794–1800. doi:10.1097/BRS.0b013e3181ecf6e4 [CrossRef]
- Gill HS, Grammatopoulos G, Adshead S, Tsialogiannis E, Tsiridis E. Molecular and immune toxicity of CoCr nanoparticles in MoM hip arthroplasty. Trends Mol Med. 2012; 18(3):145–155. doi:10.1016/j.molmed.2011.12.002 [CrossRef]
- Cooper HJ, Urban RM, Wixson RL, Meneghini RM, Jacobs JJ. Adverse local tissue reaction arising from corrosion at the femoral neck-body junction in a dual-taper stem with a cobalt-chromium modular neck. J Bone Joint Surg Am. 2013; 95(10):865–872. doi:10.2106/JBJS.L.01042 [CrossRef]
- Jacofsky DJ, Allen M. Robotics in arthroplasty: a comprehensive review. J Arthroplasty. 2016; 31(10):2353–2363. doi:10.1016/j.arth.2016.05.026 [CrossRef]
- Tatara AM, Mikos AG. Tissue engineering in orthopaedics. J Bone Joint Surg Am. 2016; 98(13):1132–1139. doi:10.2106/JBJS.16.00299 [CrossRef]
- Fernandez-Moure JS, Evangelopoulos M, Colvill K, Van Eps JL, Tasciotti E. Nanoantibiotics: a new paradigm for the treatment of surgical infection. Nanomedicine (Lond). 2017; 12(11):1319–1334. doi:10.2217/nnm-2017-0401 [CrossRef]
- Tetsworth K, Block S, Glatt V. Putting 3D modelling and 3D printing into practice: virtual surgery and preoperative planning to reconstruct complex post-traumatic skeletal deformities and defects. SICOT J. 2017; 3:16. doi:10.1051/sicotj/2016043 [CrossRef]
- Eltorai AE, Nguyen E, Daniels AH. Three-dimensional printing in orthopedic surgery. Orthopedics. 2015; 38(11):684–687. doi:10.3928/01477447-20151016-05 [CrossRef]
- Murphy SV, Atala A. 3D bioprinting of tissues and organs. Nat Biotechnol. 2014; 32(8):773–785. doi:10.1038/nbt.2958 [CrossRef]
- McCulloch P, Altman DG, Campbell WB, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009; 374(9695):1105–1112. doi:10.1016/S0140-6736(09)61116-8 [CrossRef]
- Schemitsch EH, Bhandari M, Boden SD, et al. The evidence-based approach in bringing new orthopaedic devices to market. J Bone Joint Surg Am. 2010; 92(4):1030–1037. doi:10.2106/JBJS.H.01532 [CrossRef]
- Wright JG, Weinstein S. The innovation cycle: a framework for taking surgical innovation into clinical practice. J Bone Joint Surg Am. 2013; 95(21):e164. doi:10.2106/JBJS.L.00976 [CrossRef]
- Huiskes R. Failed innovation in total hip replacement: diagnosis and proposals for a cure. Acta Orthop Scand. 1993; 64(6):699–716. doi:10.3109/17453679308994602 [CrossRef]
- Malchau H. Introducing new technology: a stepwise algorithm. Spine (Phila Pa 1976). 2000; 25(3):285. doi:10.1097/00007632-200002010-00004 [CrossRef]
- Malchau H, Bragdon CR, Muratoglu OK. The stepwise introduction of innovation into orthopedic surgery: the next level of dilemmas. J Arthroplasty. 2011; 26(6):825–831. doi:10.1016/j.arth.2010.08.007 [CrossRef]
- Zywiel MG, Johnson AJ, Mont MA. Graduated introduction of orthopaedic implants: encouraging innovation and minimizing harm. J Bone Joint Surg Am. 2012; 94(21):e158. doi:10.2106/JBJS.K.01675 [CrossRef]
- Sachdeva AK. Acquiring skills in new procedures and technology: the challenge and the opportunity. Arch Surg. 2005; 140(4):387–389. doi:10.1001/archsurg.140.4.387 [CrossRef]
- Hofbauer M, Muller B, Murawski CD, Karlsson J, Fu FH. Innovation in orthopaedic surgery as it relates to evidence-based practice. Knee Surg Sports Traumatol Arthrosc. 2013; 21(3):511–514. doi:10.1007/s00167-012-2360-4 [CrossRef]
- Sussman MD. Ethical requirements that must be met before the introduction of new procedures. Clin Orthop Relat Res. 2000; 378:15–22. doi:10.1097/00003086-200009000-00004 [CrossRef]
- Rodgers MA, Brown JV, Heirs MK, et al. Reporting of industry funded study outcome data: comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion. BMJ. 2013; 346:3981. doi:10.1136/bmj.f3981 [CrossRef]
- Buch B. FDA medical device approval: things you didn't learn in medical school or residency. Am J Orthop (Belle Mead NJ). 2007; 36(8):407–412.