{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T05:25:53Z","timestamp":1777613153554,"version":"3.51.4"},"reference-count":18,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2022,8,18]],"date-time":"2022-08-18T00:00:00Z","timestamp":1660780800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Foot Ankle Int."],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Subjective assumptions on the definition of surgical success are inherent to the design of clinical trials with a categorial outcome. The current study used reasonable alternative assumptions about surgical care to reassess data for the randomized controlled Cartiva trial (MOTION).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Data from the published study were augmented by publicly accessible internal US Food and Drug Administration documents. As in the published report, 1-sided lower bound 95% CIs (LBCI95) for the difference of proportions were calculated for a series of alternative scenarios in which the assumptions underlying what constitutes surgical success were altered.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Using a noninferiority margin of \u221215%, the MOTION trial reported success based on a 1-sided LBCI95 of \u221210.9%. Each of the 3 independent alternative scenarios analyzed yielded results that altered the primary outcome of the trial: (1) eliminating failures based solely upon radiographs findings, thereby considering a painless pseudarthrosis as a success (1-sided LBCI95 of \u221215.9%), (2) considering only major surgical revision as a failure and discounting isolated hardware removal (1-sided LBCI95 of \u221215.1%), and (3) using a visual analog scale (VAS) pain threshold of &lt;30 as the success criterion rather than a 30% reduction in VAS pain score (1-sided LBCI95 of \u221215.8%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>In this reanalysis, applying any of 3 reasonable alternative assumptions about the definition of surgical success to the data resulted in failure to prove noninferiority of Cartiva over arthrodesis, a reversal of the reported trial result. These results highlight the effect of subjective assumptions in the design of clinical trials with a categorical outcome and illustrate how differing philosophies about what constitutes surgical success can be pivotal in determining the final result.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence:<\/jats:title>\n                    <jats:p>Level II, prospective comparative study.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10711007221112928","type":"journal-article","created":{"date-parts":[[2022,8,18]],"date-time":"2022-08-18T06:19:31Z","timestamp":1660803571000},"page":"1364-1369","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":10,"title":["Philosophies of Surgical Care Are Embedded in Outcome Studies: An Illustrative Reanalysis of the Cartiva MOTION Trial"],"prefix":"10.1177","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1238-3673","authenticated-orcid":false,"given":"Gregory P.","family":"Guyton","sequence":"first","affiliation":[{"name":"Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, Baltimore, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2022,8,18]]},"reference":[{"key":"bibr1-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1177\/1071100719877147"},{"key":"bibr2-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1177\/1071100716681632"},{"key":"bibr3-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1177\/1071100720920846"},{"key":"bibr4-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1177\/1071100716635560"},{"key":"bibr5-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1177\/1071100719855049"},{"key":"bibr6-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1177\/1071100716679979"},{"key":"bibr7-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1177\/1071100718815469"},{"key":"bibr8-10711007221112928","doi-asserted-by":"publisher","DOI":"10.2106\/JBJS.20.01949"},{"key":"bibr9-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-016-0775-3"},{"key":"bibr10-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2018.05.007"},{"key":"bibr11-10711007221112928","doi-asserted-by":"publisher","DOI":"10.3109\/17453674.2013.867782"},{"key":"bibr12-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1177\/1071100720962482"},{"key":"bibr13-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1016\/j.jse.2009.03.021"},{"key":"bibr14-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1111\/j.1553-2712.1996.tb03402.x"},{"key":"bibr15-10711007221112928","doi-asserted-by":"publisher","DOI":"10.1002\/acr.21747"},{"key":"bibr16-10711007221112928","unstructured":"US Food and Drug Administration. Cartiva synthetic implant (P150017): FDA introduction. Published 2016. Accessed September 22, 2020. https:\/\/www.fda.gov\/media\/97335\/download"},{"key":"bibr17-10711007221112928","unstructured":"US Food and Drug Administration. FDA executive summary: Cartiva Synthetric Cartilage Implant. Published 2016. Accessed February 7, 2020. https:\/\/www.fda.gov\/media\/96916\/download"},{"key":"bibr18-10711007221112928","unstructured":"US Food and Drug Administration. Premarket approval (PMA). Summary of safety and effectiveness data. Published 2016. Accessed January 10, 2020. https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf15\/P150017B.pdf"}],"container-title":["Foot &amp; Ankle International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10711007221112928","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10711007221112928","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10711007221112928","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T21:25:11Z","timestamp":1777411511000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10711007221112928"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,18]]},"references-count":18,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2022,10]]}},"alternative-id":["10.1177\/10711007221112928"],"URL":"https:\/\/doi.org\/10.1177\/10711007221112928","relation":{},"ISSN":["1071-1007","1944-7876"],"issn-type":[{"value":"1071-1007","type":"print"},{"value":"1944-7876","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,8,18]]}}}