{"title":"对移位结果的 6 年随访:全髋关节置换术中粘接维生素 E 稳定型高交联聚乙烯髋臼杯与标准聚乙烯髋臼杯的随机临床试验","authors":"Olof Sköldenberg, Sebastian Mukka, Martin Magneli","doi":"10.1177/11207000241267971","DOIUrl":null,"url":null,"abstract":"Background:In a previous study we have shown that a cemented vitamin E-doped highly cross-linked polyethylene (VEPE) compared to a conventional polyethylene cup in total hip arthroplasty (THA) has a slightly higher proximal migration but significantly lower wear rates up to 2 years after surgery. In this follow-up study we investigated the same cohort at 6 years.Methods:This was a double-blinded, non-inferiority, randomised controlled trial on patients with osteoarthritis, with a mean age of 66 years. Patients were randomly assigned to receive either the conventional polyethylene cup or the VEPE cup in a 1:1 ratio. The primary endpoint was proximal implant migration of the cup measured with radiostereometric analysis (RSA). Secondary endpoints included wear rate of the cup and patient-reported outcome measurements (PROM).Results:At the 6-year follow-up, 25 patients (11 controls, 14 VEPE) were available for RSA measurements, and we found no statistically significant difference in proximal migration between the VEPE and control groups. The wear rate was significantly lower in the VEPE group compared to controls, 0.03 mm/year and 0.07 mm/year, respectively with a mean difference 0.04 mm, (95% CI, 0.02–0.06 mm). There were no cup revisions and no difference in PROM between the groups.Conclusions:Based on our 6-year results, the VEPE group exhibited no statistical or clinically relevant difference compared to the control group, and the wear rate was significantly lower in the VEPE group. The use of a cemented vitamin E-doped highly cross-linked cup is a good option in total hip arthroplasty.","PeriodicalId":12911,"journal":{"name":"HIP International","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"6-year follow-up on migration outcomes: a randomised clinical trial of cemented vitamin E-stabilised highly crosslinked versus standard polyethylene cup in total hip arthroplasty\",\"authors\":\"Olof Sköldenberg, Sebastian Mukka, Martin Magneli\",\"doi\":\"10.1177/11207000241267971\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background:In a previous study we have shown that a cemented vitamin E-doped highly cross-linked polyethylene (VEPE) compared to a conventional polyethylene cup in total hip arthroplasty (THA) has a slightly higher proximal migration but significantly lower wear rates up to 2 years after surgery. In this follow-up study we investigated the same cohort at 6 years.Methods:This was a double-blinded, non-inferiority, randomised controlled trial on patients with osteoarthritis, with a mean age of 66 years. Patients were randomly assigned to receive either the conventional polyethylene cup or the VEPE cup in a 1:1 ratio. The primary endpoint was proximal implant migration of the cup measured with radiostereometric analysis (RSA). Secondary endpoints included wear rate of the cup and patient-reported outcome measurements (PROM).Results:At the 6-year follow-up, 25 patients (11 controls, 14 VEPE) were available for RSA measurements, and we found no statistically significant difference in proximal migration between the VEPE and control groups. The wear rate was significantly lower in the VEPE group compared to controls, 0.03 mm/year and 0.07 mm/year, respectively with a mean difference 0.04 mm, (95% CI, 0.02–0.06 mm). There were no cup revisions and no difference in PROM between the groups.Conclusions:Based on our 6-year results, the VEPE group exhibited no statistical or clinically relevant difference compared to the control group, and the wear rate was significantly lower in the VEPE group. The use of a cemented vitamin E-doped highly cross-linked cup is a good option in total hip arthroplasty.\",\"PeriodicalId\":12911,\"journal\":{\"name\":\"HIP International\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2024-09-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"HIP International\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/11207000241267971\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ORTHOPEDICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"HIP International","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/11207000241267971","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
6-year follow-up on migration outcomes: a randomised clinical trial of cemented vitamin E-stabilised highly crosslinked versus standard polyethylene cup in total hip arthroplasty
Background:In a previous study we have shown that a cemented vitamin E-doped highly cross-linked polyethylene (VEPE) compared to a conventional polyethylene cup in total hip arthroplasty (THA) has a slightly higher proximal migration but significantly lower wear rates up to 2 years after surgery. In this follow-up study we investigated the same cohort at 6 years.Methods:This was a double-blinded, non-inferiority, randomised controlled trial on patients with osteoarthritis, with a mean age of 66 years. Patients were randomly assigned to receive either the conventional polyethylene cup or the VEPE cup in a 1:1 ratio. The primary endpoint was proximal implant migration of the cup measured with radiostereometric analysis (RSA). Secondary endpoints included wear rate of the cup and patient-reported outcome measurements (PROM).Results:At the 6-year follow-up, 25 patients (11 controls, 14 VEPE) were available for RSA measurements, and we found no statistically significant difference in proximal migration between the VEPE and control groups. The wear rate was significantly lower in the VEPE group compared to controls, 0.03 mm/year and 0.07 mm/year, respectively with a mean difference 0.04 mm, (95% CI, 0.02–0.06 mm). There were no cup revisions and no difference in PROM between the groups.Conclusions:Based on our 6-year results, the VEPE group exhibited no statistical or clinically relevant difference compared to the control group, and the wear rate was significantly lower in the VEPE group. The use of a cemented vitamin E-doped highly cross-linked cup is a good option in total hip arthroplasty.
期刊介绍:
HIP International is the official journal of the European Hip Society. It is the only international, peer-reviewed, bi-monthly journal dedicated to diseases of the hip. HIP International considers contributions relating to hip surgery, traumatology of the hip, prosthetic surgery, biomechanics, and basic sciences relating to the hip. HIP International invites reviews from leading specialists with the aim of informing its readers of current evidence-based best practice.
The journal also publishes supplements containing proceedings of symposia, special meetings or articles of special educational merit.
HIP International is divided into six independent sections led by editors of the highest scientific merit. These sections are:
• Biomaterials
• Biomechanics
• Conservative Hip Surgery
• Paediatrics
• Primary and Revision Hip Arthroplasty
• Traumatology