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

IF 1.8 Q2 ORTHOPEDICS SICOT-J Pub Date : 2022-04-04 DOI:10.1051/sicotj/2022005
R. D’Ambrosi, A. Toni, J. Czubak, Jorge Guadilla, L. Lieber, I. Mariani, N. Ursino
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引用次数: 1

摘要

本多中心前瞻性队列研究旨在评估采用Kinectiv®技术的CLS®BreviusTM系统的安全性、临床和放射学性能。材料和方法:共有222名连续受试者,从五个不同的中心招募,符合初级全髋关节置换术(THA)的条件,被纳入研究。所有受试者均接受了CLS®BreviusTM Stem with Kinectiv®Technology。所有入组的研究对象都进行了术前临床和影像学评估。此外,所有受试者在术后6个月、1、2、3和5年进行了临床、功能和影像学评估。这些评估包括植入物存活、疼痛和功能表现(Harris髋关节评分[HHS]、加州大学洛杉矶分校[UCLA]活动评分、牛津髋关节评分)、受试者生活质量(iq - 5d)、放射学参数、并发症和血液中金属离子(铝和钛)浓度。结果:随访期间未进行复查。222例患者中,只有76例完成了5年随访。只有7例和5例患者分别进行了铝和钛的5年评估。重复测量的方差分析显示,所有临床参数在加班时间中均有整体改善;此外,与术前相比,临床评分在5年时有统计学意义上的改善(p < 0.001)。铝和钛在不同时间点重复测量无差异(p < 0.05)。总共报告了6例并发症,其中只有2例与髋部有关。结论:CLS®BreviusTM Stem与Kinectiv®Technology的功能表明,受试者在THA后的幸福感显著增加,与年龄、性别、BMI、既往手术、初诊和生活方式无关。
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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.
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来源期刊
SICOT-J
SICOT-J ORTHOPEDICS-
CiteScore
3.20
自引率
12.50%
发文量
44
审稿时长
14 weeks
期刊最新文献
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