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• W2023302686 abstract "Dear Editor: We read with interest the “instructional course” entitled “Management of Extensive Tibial Osteolysis with the Agility™ Total Ankle Replacement Systems Using Geometric Metal-Reinforced Polymethylmethacrylate Cement Augmentation” (1Prissel M.A. Roukis T.S. Management of extensive tibial osteolysis with the Agility™ total ankle replacement systems using geometric metal-reinforced polymethylmethacrylate cement augmentation.J Foot Ankle Surg. 2014; 53: 101-107Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar) in the January/February issue of The Journal of Foot & Ankle Surgery®. We have significant concerns over the information presented therein. As such, we are compelled to point out some of the significant flaws in the procedure such that readers do not adopt these techniques for revision of total ankle arthroplasty. Many of the concepts presented are contrary to standard principles followed when revising any metal-backed implant but, in particular, the total ankle. Further, there are many misleading statements or flawed logic within this manuscript. First of all, it makes little sense to us why the authors would revise the Agility™ implant with the same implant when, in fact, these implants are well known to cause the extensive osteolysis such as seen in this manuscript. In fact, the authors state that this implant should not be used as a primary implant. Although the Agility™ was really the only available implant in the United States until approximately 2005, it is no surprise that the rate of polyethylene wear was so extensive based on the poor inherent mechanics and high contact pressures (2Nicholson J.J. Parks B.G. Stroud C.C. Myerson M.S. Joint contact characteristics in Agility Total Ankle Arthroplasty.Clin Orth Relat Res. 2004; 424: 125-129Crossref PubMed Scopus (30) Google Scholar). In the very first paragraph, the authors imply that “component exchange” is appropriate for the Agility™ implant, based on statistics from one of their own previously published papers (3Roukis T.S. Incidence of revision after primary implantation of the Agility™ total ankle replacement system: a systematic review.J Foot Ankle Surg. 2012; 51: 198-204Abstract Full Text Full Text PDF PubMed Scopus (46) Google Scholar). That paper states that component exchange only was appropriate in over 80% of the revised ankles followed for an average of less than 2 years! This is grossly misleading because there were no other implants available in the United States for revision except the Agility™ during the overwhelming majority of the study period. There are much better components available for revision today. As such, it seems disingenuous to suggest that because Agility™ component exchange was done before 2007, it is appropriate to do so now. Furthermore, the revision components that are used in the subject of this instructional course have the same flawed metal-polyethylene interface that has absolutely no capacity to improve the rate of wear (2Nicholson J.J. Parks B.G. Stroud C.C. Myerson M.S. Joint contact characteristics in Agility Total Ankle Arthroplasty.Clin Orth Relat Res. 2004; 424: 125-129Crossref PubMed Scopus (30) Google Scholar). The authors later contend that revision of the Agility™—especially in those with a united syndesmosis and stable tibial component, metallic talar component exchange, and management of the cystic lesions—is the most appropriate revision option, even with extensive tibial osteolysis present. This also does not make sense to us. With a combined experience of more than 2000 primary implants and 200 revisions, we know it is extremely rare to have a “stable” tibial component with extensive osteolysis. Asking the reader to adopt the notion that the tibial components seen in this manuscript are stable is fanciful. In fact, we believe these terms are mutually exclusive. The authors then go on to rationalize the use of cement as a replacement for the bone loss by stating that there are other causes for osteolysis besides polymethylmethacrylate. Although that is true, cement disease still exists! The impact of cement disease has been mitigated in other lower extremity joints due to improved materials, better handling, and a rational mechanical application of the material. The very early total ankle implants were cemented; in fact, cement disease was ubiquitous and accounted, in part, for the extremely high and catastrophic failure rate. The use of cement as described in these papers essentially replicates the same flawed concept responsible for failure in the early days of total ankle replacement. Transfer of the load to the weak distal metaphyseal bone of the tibia by placing cement in the locale of these large defects is doomed to fail just as it was in the 1980s. At the very least, there is no increase in stability by virtue of the cement. Fig. 6F (1Prissel M.A. Roukis T.S. Management of extensive tibial osteolysis with the Agility™ total ankle replacement systems using geometric metal-reinforced polymethylmethacrylate cement augmentation.J Foot Ankle Surg. 2014; 53: 101-107Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar) shows a postoperative x-ray with a distinct lytic line around the cement mantle. How can this be considered “stable”? Moreover, we do not understand the contention that components are “stable” by virtue of bony ingrowth only to the tibial keel. The keel represents an extremely small percentage of the total surface area of the tibial tray and metaphyseal bone of the distal tibia is ill-suited to provide support to the tibial component. The suggestion that this situation is “stabilized” by this cement technique is flawed. The additional radiation exposure of the patient to stress x-rays is also of concern. It makes little sense to assess component stability via stress radiography, insofar that the obligate micromotion in these cases is virtually undetectable to the naked eye as the authors suggest in the caption to Figs. 1 and 7 (1Prissel M.A. Roukis T.S. Management of extensive tibial osteolysis with the Agility™ total ankle replacement systems using geometric metal-reinforced polymethylmethacrylate cement augmentation.J Foot Ankle Surg. 2014; 53: 101-107Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar). The authors go on to describe the geometric metal augmentation technique. We are baffled as to the rationale of process. Native polymethylmethacrylate is well suited to sustain vertical load and, when mixed with a vacuum, has an extremely low propensity for collapse. It is illogical to adopt the notion that these misshapen Steinmann pins or K-wires will fortify the cement such that it will prevent failure. Although the cement will not fail in the first place, the cement cannot possibly be loaded enough to fail because there is no stable substrate on the proximal side of the body of cement. Although probably a minor issue in the global consideration of this technique, the application of a stainless steel implant against the titanium syndesmotic screws is generally not recommended (Fig. 5) (1Prissel M.A. Roukis T.S. Management of extensive tibial osteolysis with the Agility™ total ankle replacement systems using geometric metal-reinforced polymethylmethacrylate cement augmentation.J Foot Ankle Surg. 2014; 53: 101-107Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar). One of our biggest concerns is the remains of the biologically active material that is not dealt with during the operation. In fact, the authors maintain that the membranes of these cysts can serve as a “backboard” for the cementing process! The macrophages that are housed in the remaining cysts and cyst membranes are responsible for ingestion of the polyethylene wear debris, remain active, and will continue to produce inflammatory products that will persist to erode even more bone. These cysts and membranes must be evacuated during revision surgery to improve survivorship and unfortunately, this was not done. Fig. 6 in particular shows numerous undisturbed cysts in the medial and lateral malleoli that contain active macrophages and polywear debris (1Prissel M.A. Roukis T.S. Management of extensive tibial osteolysis with the Agility™ total ankle replacement systems using geometric metal-reinforced polymethylmethacrylate cement augmentation.J Foot Ankle Surg. 2014; 53: 101-107Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar). Fig. 7 also shows significant unmitigated bioactive cysts behind the tibial component (1Prissel M.A. Roukis T.S. Management of extensive tibial osteolysis with the Agility™ total ankle replacement systems using geometric metal-reinforced polymethylmethacrylate cement augmentation.J Foot Ankle Surg. 2014; 53: 101-107Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar). We would like to reinforce to the readers that these components must be removed to excavate all of the bioactive material. The authors opine that their method is more cost effective than other options. This may be true in the short run, but unfortunately the etiology of the osteolysis is not addressed and these patients will suffer from progressive expansile osteolysis, component subsidence, and the possibility of pathologic fracture; this will make proper revision much more difficult and more costly. Lastly, what is most disturbing is that one of us reviewed this paper and unequivocally recommended against publication because the concepts are so contrary to those of revision surgery of the total ankle. Further, the novelty of these reports seems to be the “metal” reinforcement and as such represents solving a problem that does not exist. Above all, the premise of peer review should be upheld and not ignored as appears to be in this case. In fact, one of the authors of this paper has written about the “rigors” of peer review: “This is because the publication of research manuscripts is not only the desired outcome but also represents a rigorous process that includes significant analysis and scrutiny of the research design, methods, results, and conclusions, thereby improving the scientific validity of the information presented” (4Roukis T.S. Publication rates of manuscript presentations at the American College of Foot and Ankle Surgeons Annual Scientific Conference between 1999 and 2008.J Foot Ankle Surg. 2011; 50: 416-419Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar). We strongly caution the readers of these papers against adoption of these concepts during revision total ankle surgery." @default.
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• W2023302686 title "Ill-conceived Total Ankle Revision Technique" @default.
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