R. D’Ambrosi, A. Toni, J. Czubak, Jorge Guadilla, L. Lieber, I. Mariani, N. Ursino
{"title":"一项国际前瞻性多中心试点研究显示,一种新的较短模块化干假体治疗终末期髋关节骨性关节炎的临床和放射学结果令人满意","authors":"R. D’Ambrosi, A. Toni, J. Czubak, Jorge Guadilla, L. Lieber, I. Mariani, N. Ursino","doi":"10.1051/sicotj/2022005","DOIUrl":null,"url":null,"abstract":"Introduction: This multicenter prospective cohort study aimed to assess the safety and clinical and radiologic performance of the CLS® BreviusTM Stem with Kinectiv® Technology. Material and Methods: A total of 222 consecutive subjects, recruited in five different centers, qualifying for primary total hip arthroplasty (THA), were enrolled in the study. All the subjects received the CLS® BreviusTM Stem with Kinectiv® Technology. All the enrolled study subjects underwent pre-operative clinical and radiographic evaluation. Additionally, all subjects underwent post-operative clinical, functional and radiographic evaluations at 6 months and 1, 2, 3, and 5 years. These evaluations included implant survival, pain and functional performance (Harris Hip Score [HHS], University of California, Los Angeles [UCLA] Activity Score, Oxford Hip Score), subject quality-of-life (EQ-5D), radiographic parameters, complications, and concentration of metal ions (aluminum and titanium) in blood. Results: No revisions were performed during the follow-up period. Of the 222 patients, only 76 completed the 5-year follow-up. Only 7 and 5 patients had aluminum and titanium 5-year evaluations, respectively. All the clinical parameters showed an overall improvement in the overtime measured with ANOVA for repeated measures; furthermore, the clinical scores showed a statistically significant improvement at 5 years with respect to pre-operative value (p < 0.001). Aluminum and titanium showed no variation for repeated measures at different time points (p > 0.05). A total of six complications were reported, of which only two were hip-related. Conclusions: The function of the CLS® BreviusTM Stem with Kinectiv® Technology indicated that subject well-being significantly increased following THA regardless of age, gender, BMI, previous surgery, primary diagnosis, and lifestyle.","PeriodicalId":46378,"journal":{"name":"SICOT-J","volume":"67 10","pages":""},"PeriodicalIF":1.8000,"publicationDate":"2022-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Satisfactory clinical and radiologic outcomes with a new shorter and modular stem for end-stage hip osteoarthritis: an international prospective multicentre pilot study\",\"authors\":\"R. D’Ambrosi, A. Toni, J. Czubak, Jorge Guadilla, L. Lieber, I. Mariani, N. Ursino\",\"doi\":\"10.1051/sicotj/2022005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Introduction: This multicenter prospective cohort study aimed to assess the safety and clinical and radiologic performance of the CLS® BreviusTM Stem with Kinectiv® Technology. Material and Methods: A total of 222 consecutive subjects, recruited in five different centers, qualifying for primary total hip arthroplasty (THA), were enrolled in the study. All the subjects received the CLS® BreviusTM Stem with Kinectiv® Technology. All the enrolled study subjects underwent pre-operative clinical and radiographic evaluation. Additionally, all subjects underwent post-operative clinical, functional and radiographic evaluations at 6 months and 1, 2, 3, and 5 years. These evaluations included implant survival, pain and functional performance (Harris Hip Score [HHS], University of California, Los Angeles [UCLA] Activity Score, Oxford Hip Score), subject quality-of-life (EQ-5D), radiographic parameters, complications, and concentration of metal ions (aluminum and titanium) in blood. Results: No revisions were performed during the follow-up period. Of the 222 patients, only 76 completed the 5-year follow-up. Only 7 and 5 patients had aluminum and titanium 5-year evaluations, respectively. All the clinical parameters showed an overall improvement in the overtime measured with ANOVA for repeated measures; furthermore, the clinical scores showed a statistically significant improvement at 5 years with respect to pre-operative value (p < 0.001). Aluminum and titanium showed no variation for repeated measures at different time points (p > 0.05). A total of six complications were reported, of which only two were hip-related. Conclusions: The function of the CLS® BreviusTM Stem with Kinectiv® Technology indicated that subject well-being significantly increased following THA regardless of age, gender, BMI, previous surgery, primary diagnosis, and lifestyle.\",\"PeriodicalId\":46378,\"journal\":{\"name\":\"SICOT-J\",\"volume\":\"67 10\",\"pages\":\"\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2022-04-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"SICOT-J\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1051/sicotj/2022005\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ORTHOPEDICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"SICOT-J","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1051/sicotj/2022005","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
Satisfactory clinical and radiologic outcomes with a new shorter and modular stem for end-stage hip osteoarthritis: an international prospective multicentre pilot study
Introduction: This multicenter prospective cohort study aimed to assess the safety and clinical and radiologic performance of the CLS® BreviusTM Stem with Kinectiv® Technology. Material and Methods: A total of 222 consecutive subjects, recruited in five different centers, qualifying for primary total hip arthroplasty (THA), were enrolled in the study. All the subjects received the CLS® BreviusTM Stem with Kinectiv® Technology. All the enrolled study subjects underwent pre-operative clinical and radiographic evaluation. Additionally, all subjects underwent post-operative clinical, functional and radiographic evaluations at 6 months and 1, 2, 3, and 5 years. These evaluations included implant survival, pain and functional performance (Harris Hip Score [HHS], University of California, Los Angeles [UCLA] Activity Score, Oxford Hip Score), subject quality-of-life (EQ-5D), radiographic parameters, complications, and concentration of metal ions (aluminum and titanium) in blood. Results: No revisions were performed during the follow-up period. Of the 222 patients, only 76 completed the 5-year follow-up. Only 7 and 5 patients had aluminum and titanium 5-year evaluations, respectively. All the clinical parameters showed an overall improvement in the overtime measured with ANOVA for repeated measures; furthermore, the clinical scores showed a statistically significant improvement at 5 years with respect to pre-operative value (p < 0.001). Aluminum and titanium showed no variation for repeated measures at different time points (p > 0.05). A total of six complications were reported, of which only two were hip-related. Conclusions: The function of the CLS® BreviusTM Stem with Kinectiv® Technology indicated that subject well-being significantly increased following THA regardless of age, gender, BMI, previous surgery, primary diagnosis, and lifestyle.