Mark W Little, Sankalp Agarwal, Ibrohim M Khikmatovich, Joan McCabe, Masum Pandey, Andrew L Lewis, Liam Farrissey, Sherzod A Iskhakov
{"title":"一种新的可吸收微球栓塞剂用于膝动脉栓塞治疗膝关节骨关节炎继发疼痛的首次人体评估。","authors":"Mark W Little, Sankalp Agarwal, Ibrohim M Khikmatovich, Joan McCabe, Masum Pandey, Andrew L Lewis, Liam Farrissey, Sherzod A Iskhakov","doi":"10.1016/j.jvir.2025.07.010","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the safety and efficacy of Genicular Artery Embolization (GAE) using resorbable microspherical embolic agent to treat pain secondary to knee osteoarthritis.</p><p><strong>Materials and methods: </strong>This prospective, single-arm, unblinded, first-in-human study was performed in 15 patients (12 women, mean age 62.8). GAE was performed with 200 ± 75mm resorbable alginate microspheres (SakuraBead; Crannmed, Galway, Ireland). Primary endpoint was safety, with efficacy evaluated as a secondary endpint using the pain Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, 1, 3, and, 6 months. Adverse events were recorded at all timepoints.</p><p><strong>Results: </strong>GAE was technically successful in all patients. There were six adverse events recorded in six different patients, all were minor and self-limiting (Grade 1). The percentage reduction in VAS, WOMAC Total and WOMAC Pain scores was calculated for individual patients. This showed there was a statistically significant reduction (p<0.001) in the mean VAS score of 76% , 77% and 63% at 1, 3 and 6 months respectively. There was a 78% reduction in WOMAC Total Score at both 1 and 3 months and 76% reduction at 6 months (P<0.01); this was accompanied by a reduction in WOMAC pain of 78%, 81% and 78% at 1, 3 and 6 months respectively (p<0.01).</p><p><strong>Conclusions: </strong>In this limited pilot study, GAE using alginate resorbable microspheres was safe and produced significant improvement in pain and function in patients with KOA maintained to 6-month follow-up.</p>","PeriodicalId":49962,"journal":{"name":"Journal of Vascular and Interventional Radiology","volume":" ","pages":""},"PeriodicalIF":2.6000,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"First-in-Human Evaluation of a New Resorbable Microspherical Embolic Agent for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteroarthritis.\",\"authors\":\"Mark W Little, Sankalp Agarwal, Ibrohim M Khikmatovich, Joan McCabe, Masum Pandey, Andrew L Lewis, Liam Farrissey, Sherzod A Iskhakov\",\"doi\":\"10.1016/j.jvir.2025.07.010\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To evaluate the safety and efficacy of Genicular Artery Embolization (GAE) using resorbable microspherical embolic agent to treat pain secondary to knee osteoarthritis.</p><p><strong>Materials and methods: </strong>This prospective, single-arm, unblinded, first-in-human study was performed in 15 patients (12 women, mean age 62.8). GAE was performed with 200 ± 75mm resorbable alginate microspheres (SakuraBead; Crannmed, Galway, Ireland). Primary endpoint was safety, with efficacy evaluated as a secondary endpint using the pain Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, 1, 3, and, 6 months. Adverse events were recorded at all timepoints.</p><p><strong>Results: </strong>GAE was technically successful in all patients. There were six adverse events recorded in six different patients, all were minor and self-limiting (Grade 1). The percentage reduction in VAS, WOMAC Total and WOMAC Pain scores was calculated for individual patients. This showed there was a statistically significant reduction (p<0.001) in the mean VAS score of 76% , 77% and 63% at 1, 3 and 6 months respectively. There was a 78% reduction in WOMAC Total Score at both 1 and 3 months and 76% reduction at 6 months (P<0.01); this was accompanied by a reduction in WOMAC pain of 78%, 81% and 78% at 1, 3 and 6 months respectively (p<0.01).</p><p><strong>Conclusions: </strong>In this limited pilot study, GAE using alginate resorbable microspheres was safe and produced significant improvement in pain and function in patients with KOA maintained to 6-month follow-up.</p>\",\"PeriodicalId\":49962,\"journal\":{\"name\":\"Journal of Vascular and Interventional Radiology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-07-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Vascular and Interventional Radiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jvir.2025.07.010\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Vascular and Interventional Radiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jvir.2025.07.010","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
First-in-Human Evaluation of a New Resorbable Microspherical Embolic Agent for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteroarthritis.
Purpose: To evaluate the safety and efficacy of Genicular Artery Embolization (GAE) using resorbable microspherical embolic agent to treat pain secondary to knee osteoarthritis.
Materials and methods: This prospective, single-arm, unblinded, first-in-human study was performed in 15 patients (12 women, mean age 62.8). GAE was performed with 200 ± 75mm resorbable alginate microspheres (SakuraBead; Crannmed, Galway, Ireland). Primary endpoint was safety, with efficacy evaluated as a secondary endpint using the pain Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, 1, 3, and, 6 months. Adverse events were recorded at all timepoints.
Results: GAE was technically successful in all patients. There were six adverse events recorded in six different patients, all were minor and self-limiting (Grade 1). The percentage reduction in VAS, WOMAC Total and WOMAC Pain scores was calculated for individual patients. This showed there was a statistically significant reduction (p<0.001) in the mean VAS score of 76% , 77% and 63% at 1, 3 and 6 months respectively. There was a 78% reduction in WOMAC Total Score at both 1 and 3 months and 76% reduction at 6 months (P<0.01); this was accompanied by a reduction in WOMAC pain of 78%, 81% and 78% at 1, 3 and 6 months respectively (p<0.01).
Conclusions: In this limited pilot study, GAE using alginate resorbable microspheres was safe and produced significant improvement in pain and function in patients with KOA maintained to 6-month follow-up.
期刊介绍:
JVIR, published continuously since 1990, is an international, monthly peer-reviewed interventional radiology journal. As the official journal of the Society of Interventional Radiology, JVIR is the peer-reviewed journal of choice for interventional radiologists, radiologists, cardiologists, vascular surgeons, neurosurgeons, and other clinicians who seek current and reliable information on every aspect of vascular and interventional radiology. Each issue of JVIR covers critical and cutting-edge medical minimally invasive, clinical, basic research, radiological, pathological, and socioeconomic issues of importance to the field.