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{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,1,18]],"date-time":"2024-01-18T19:02:55Z","timestamp":1705604575607},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2023,4,3]],"date-time":"2023-04-03T00:00:00Z","timestamp":1680480000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,4,3]],"date-time":"2023-04-03T00:00:00Z","timestamp":1680480000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004374","name":"Medtronic","doi-asserted-by":"publisher"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Cardiovasc Intervent Radiol"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n <jats:title>Purpose<\/jats:title>\n <jats:p>The OsteoCool Tumor Ablation Post-Market Study (OPuS One) was a prospective, multi-national, single-arm study to investigate safety and effectiveness of radiofrequency ablation (RFA) for palliation of painful lytic bone metastases with 12\u00a0months of follow-up. RFA has demonstrated effective palliation of osseous metastases in small clinical studies with short-term follow-up; however, a long-term assessment with robust subject numbers is lacking.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Materials and Methods<\/jats:title>\n <jats:p>Prospective assessments were conducted at Baseline, 3\u00a0days, 1\u00a0week, and 1, 3, 6, and 12-months. Pain and quality of life were measured prior to RFA and postoperatively using the Brief Pain Inventory, European Quality of Life\u20145 Dimension, and European Organization for Research and Treatment of Cancer Care Quality of Life Questionnaire for palliative care. Radiation, chemotherapy and opioid usage, and related adverse events were collected.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Results<\/jats:title>\n <jats:p>206 subjects were treated with RFA at 15 institutions in OPuS One. Worst pain, average pain, pain interference and quality of life significantly improved at all visits starting 3\u00a0days post-RFA and sustained to 12\u00a0months (<jats:italic>P<\/jats:italic>\u2009<\u20090.0001). Post hoc analysis found neither systemic chemotherapy nor local radiation therapy at the index site of RFA influenced worst pain, average pain, or pain interference. Six subjects had device\/procedure-related adverse events.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Conclusion<\/jats:title>\n <jats:p>RFA for lytic metastases provides rapid (within 3\u00a0days) and statistically significant pain and quality of life improvements with sustained long-term relief through 12\u00a0months and a high degree of safety, independent of radiation.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Level of Evidence: 2b, Prospective, Non-Randomized, Post-Market study<\/jats:title>\n <jats:p>This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.springer.com\/00266\">www.springer.com\/00266<\/jats:ext-link>.<\/jats:p>\n <\/jats:sec>","DOI":"10.1007\/s00270-023-03417-x","type":"journal-article","created":{"date-parts":[[2023,4,3]],"date-time":"2023-04-03T19:02:41Z","timestamp":1680548561000},"page":"600-609","update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Radiofrequency Ablation Provides Rapid and Durable Pain Relief for the Palliative Treatment of Lytic Bone Metastases Independent of Radiation Therapy: Final Results from the OsteoCool Tumor Ablation Post-Market Study"],"prefix":"10.1007","volume":"46","author":[{"ORCID":"http:\/\/orcid.org\/0000-0002-1272-5530","authenticated-orcid":false,"given":"Jason","family":"Levy","sequence":"first","affiliation":[]},{"given":"Elizabeth","family":"David","sequence":"additional","affiliation":[]},{"given":"Thomas","family":"Hopkins","sequence":"additional","affiliation":[]},{"given":"Jonathan","family":"Morris","sequence":"additional","affiliation":[]},{"given":"Nam D.","family":"Tran","sequence":"additional","affiliation":[]},{"given":"Hamed","family":"Farid","sequence":"additional","affiliation":[]},{"given":"Francesco","family":"Massari","sequence":"additional","affiliation":[]},{"given":"William G.","family":"O\u2019Connell","sequence":"additional","affiliation":[]},{"given":"Alexander","family":"Vogel","sequence":"additional","affiliation":[]},{"given":"Afshin","family":"Gangi","sequence":"additional","affiliation":[]},{"given":"Peter","family":"Sunenshine","sequence":"additional","affiliation":[]},{"given":"Robert","family":"Dixon","sequence":"additional","affiliation":[]},{"given":"Nicolas","family":"Von der H\u00f6h","sequence":"additional","affiliation":[]},{"given":"Sandeep","family":"Bagla","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2023,4,3]]},"reference":[{"issue":"6","key":"3417_CR1","doi-asserted-by":"publisher","first-page":"972","DOI":"10.1093\/annonc\/mdi191","volume":"16","author":"CS Cleeland","year":"2005","unstructured":"Cleeland CS, Portenoy RK, Rue M, et al. 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JL is also a consultant for Varian and provides lectures\/presentations for Sirtex, which also provides support to attend meetings. TH is a paid consultant for Medtronic and receives research funding from SPR Therapeutics. JM is a paid consultant and lecturer for Medtronic. NDT is a paid consultant, Advisory Board member, and lecturer for Medtronic. AV and PS receive personal fees from Medtronic. AG has patents planned, issued or pending from APRIOMED and receives royalties. NVdH is a paid consultant for Medtronic. SB is a paid consultant for Boston Scientific, Medtronic, and Terumo, and Varian. None of the other authors have identified a conflict of interest. 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