Branco S van Minnen, Petra J C Heesterbeek, Koen C Defoort, Pieter J Emans, Ewoud R A van Arkel, Thijmen Struik, Liesbeth M Jutten, Saskia Susan, Sebastiaan A W van de Groes, Nico Verdonschot, Tony G van Tienen
{"title":"植入柔性内侧半月板假体一年后，虽然失败率高，但临床表现良好。","authors":"Branco S van Minnen, Petra J C Heesterbeek, Koen C Defoort, Pieter J Emans, Ewoud R A van Arkel, Thijmen Struik, Liesbeth M Jutten, Saskia Susan, Sebastiaan A W van de Groes, Nico Verdonschot, Tony G van Tienen","doi":"10.1002/ksa.12454","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>After unsatisfactory results in a first-in-human clinical investigation with an anatomically shaped medial meniscus prosthesis, the prosthesis and its fixation technique were altered. This interim analysis of a prospective single-arm clinical investigation aims to evaluate safety and clinical performance in a first-in-human study with the redesigned meniscus prosthesis system.</p><p><strong>Methods: </strong>Ten patients suffering from medial postmeniscectomy pain syndrome were treated with the meniscus prosthesis. Patient-reported outcome measures were obtained at baseline and at 6-week, 3-, 6-, and 12-month follow-up. Radiographs and magnetic resonance imaging scans were obtained to evaluate joint degeneration and prosthesis location.</p><p><strong>Results: </strong>The device alterations resolved the issues occurring with the previous design, but four prostheses were explanted after fixation failure or subluxation of the prosthesis. Five out of six patients who reached 1-year follow-up reported a clinically significant improvement of the knee injury and osteoarthritis outcome score pain subscale. Imaging revealed no adverse effects on joint degeneration.</p><p><strong>Conclusion: </strong>The failure mechanisms that occurred with the previous design have been resolved, but the new fixation technique introduced new safety issues. Improvement of positioning and fixation techniques are considered essential future adaptations to reduce the risk of failure. The good clinical outcomes reported by the patients reaching 1-year follow-up indicate that the medial meniscus prosthesis is a potential solution for patients suffering from postmeniscectomy pain syndrome.</p><p><strong>Level of evidence: </strong>Level II.</p>","PeriodicalId":17880,"journal":{"name":"Knee Surgery, Sports Traumatology, Arthroscopy","volume":" ","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"High failure rate but promising clinical performance after implantation of a flexible medial meniscus prosthesis at 1-year follow-up.\",\"authors\":\"Branco S van Minnen, Petra J C Heesterbeek, Koen C Defoort, Pieter J Emans, Ewoud R A van Arkel, Thijmen Struik, Liesbeth M Jutten, Saskia Susan, Sebastiaan A W van de Groes, Nico Verdonschot, Tony G van Tienen\",\"doi\":\"10.1002/ksa.12454\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>After unsatisfactory results in a first-in-human clinical investigation with an anatomically shaped medial meniscus prosthesis, the prosthesis and its fixation technique were altered. This interim analysis of a prospective single-arm clinical investigation aims to evaluate safety and clinical performance in a first-in-human study with the redesigned meniscus prosthesis system.</p><p><strong>Methods: </strong>Ten patients suffering from medial postmeniscectomy pain syndrome were treated with the meniscus prosthesis. Patient-reported outcome measures were obtained at baseline and at 6-week, 3-, 6-, and 12-month follow-up. Radiographs and magnetic resonance imaging scans were obtained to evaluate joint degeneration and prosthesis location.</p><p><strong>Results: </strong>The device alterations resolved the issues occurring with the previous design, but four prostheses were explanted after fixation failure or subluxation of the prosthesis. Five out of six patients who reached 1-year follow-up reported a clinically significant improvement of the knee injury and osteoarthritis outcome score pain subscale. Imaging revealed no adverse effects on joint degeneration.</p><p><strong>Conclusion: </strong>The failure mechanisms that occurred with the previous design have been resolved, but the new fixation technique introduced new safety issues. Improvement of positioning and fixation techniques are considered essential future adaptations to reduce the risk of failure. The good clinical outcomes reported by the patients reaching 1-year follow-up indicate that the medial meniscus prosthesis is a potential solution for patients suffering from postmeniscectomy pain syndrome.</p><p><strong>Level of evidence: </strong>Level II.</p>\",\"PeriodicalId\":17880,\"journal\":{\"name\":\"Knee Surgery, Sports Traumatology, Arthroscopy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2024-09-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Knee Surgery, Sports Traumatology, Arthroscopy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/ksa.12454\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ORTHOPEDICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Knee Surgery, Sports Traumatology, Arthroscopy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/ksa.12454","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
High failure rate but promising clinical performance after implantation of a flexible medial meniscus prosthesis at 1-year follow-up.
Purpose: After unsatisfactory results in a first-in-human clinical investigation with an anatomically shaped medial meniscus prosthesis, the prosthesis and its fixation technique were altered. This interim analysis of a prospective single-arm clinical investigation aims to evaluate safety and clinical performance in a first-in-human study with the redesigned meniscus prosthesis system.
Methods: Ten patients suffering from medial postmeniscectomy pain syndrome were treated with the meniscus prosthesis. Patient-reported outcome measures were obtained at baseline and at 6-week, 3-, 6-, and 12-month follow-up. Radiographs and magnetic resonance imaging scans were obtained to evaluate joint degeneration and prosthesis location.
Results: The device alterations resolved the issues occurring with the previous design, but four prostheses were explanted after fixation failure or subluxation of the prosthesis. Five out of six patients who reached 1-year follow-up reported a clinically significant improvement of the knee injury and osteoarthritis outcome score pain subscale. Imaging revealed no adverse effects on joint degeneration.
Conclusion: The failure mechanisms that occurred with the previous design have been resolved, but the new fixation technique introduced new safety issues. Improvement of positioning and fixation techniques are considered essential future adaptations to reduce the risk of failure. The good clinical outcomes reported by the patients reaching 1-year follow-up indicate that the medial meniscus prosthesis is a potential solution for patients suffering from postmeniscectomy pain syndrome.
期刊介绍：
Few other areas of orthopedic surgery and traumatology have undergone such a dramatic evolution in the last 10 years as knee surgery, arthroscopy and sports traumatology. Ranked among the top 33% of journals in both Orthopedics and Sports Sciences, the goal of this European journal is to publish papers about innovative knee surgery, sports trauma surgery and arthroscopy. Each issue features a series of peer-reviewed articles that deal with diagnosis and management and with basic research. Each issue also contains at least one review article about an important clinical problem. Case presentations or short notes about technical innovations are also accepted for publication.
The articles cover all aspects of knee surgery and all types of sports trauma; in addition, epidemiology, diagnosis, treatment and prevention, and all types of arthroscopy (not only the knee but also the shoulder, elbow, wrist, hip, ankle, etc.) are addressed. Articles on new diagnostic techniques such as MRI and ultrasound and high-quality articles about the biomechanics of joints, muscles and tendons are included. Although this is largely a clinical journal, it is also open to basic research with clinical relevance.
Because the journal is supported by a distinguished European Editorial Board, assisted by an international Advisory Board, you can be assured that the journal maintains the highest standards.
Official Clinical Journal of the European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA).
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