knee osteoarthritis

膝骨关节炎
  • 文章类型: Journal Article
    背景:下肢的长腿额片用于评估膝关节骨关节炎。考虑到骨关节炎中排列变化的三维(3D)性质,股骨和胫骨的体位改变超出冠状平面(面内),包括横向和矢状平面(面外)。这项研究调查了这些平面外因素对额叶射线照片中观察到的平面内膝关节对准参数的影响。
    方法:共检查了97例骨关节炎患者的膝关节。使用3D到二维(2D)图像匹配技术,我们评估了从世界坐标系中的额叶X射线照片观察的站立姿势中股骨和胫骨的3D姿势。进行统计分析以探索在相同条件下从正面射线照片获得的这些3D姿势和2D对准参数之间的关联。
    结果:股骨表现出2.7°的内侧倾斜度,后倾角为3.9°,和4.2°的内部旋转,而胫骨的侧向倾角为6.4°,前倾角为6.7°,和6.7°的内部旋转。股骨和胫骨的冠状和旋转姿势均影响髋-膝-踝角度,机械轴百分比,和胫骨近端内侧角。然而,胫骨仅冠状因素影响胫骨关节线相对于地板的倾斜度。
    结论:应注意股骨和胫骨平面外姿势对下肢额叶平片评估参数的潜在影响。
    BACKGROUND: Long-leg frontal radiographs of the lower extremities are used to assess knee osteoarthritis. Given the three-dimensional (3D) nature of alignment changes in osteoarthritis, postural alterations in the femur and tibia extend beyond the coronal plane (in-plane) to include the transverse and sagittal planes (out-of-plane). This study investigates the impact of these out-of-plane factors on in-plane knee alignment parameters observed in frontal radiographs.
    METHODS: A total of 97 osteoarthritic knees in women were examined. Using a 3D-to-two-dimensional (2D) image matching technique, we evaluated the 3D postures of the femur and tibia in the standing position as viewed from frontal radiographs in the world coordinate system. Statistical analyses were conducted to explore associations between these 3D postures and 2D alignment parameters obtained from frontal radiographs under identical conditions.
    RESULTS: The femur exhibited a medial inclination of 2.7°, a posterior inclination of 3.9°, and an internal rotation of 4.2°, whereas the tibia showed a lateral inclination of 6.4°, an anterior inclination of 6.7°, and an internal rotation of 6.7°. Both coronal and rotational postures of femur and tibia influenced the hip-knee-ankle angle, mechanical axis percentage, and medial proximal tibial angle. However, only coronal factors of tibia impacted tibial joint line obliquity relative to the floor.
    CONCLUSIONS: Attention should be paid to the potential impact of the out-of-plane postures of the femur and tibia on parameters assessed in plain frontal radiographs of the lower extremities.
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  • 文章类型: Journal Article
    目前的膝骨关节炎指南强烈建议将药物和非药物干预相结合。然而,很少有系统评价验证了它们的综合疗效.在这项研究中,我们研究了药物联合运动对膝骨关节炎的影响。
    在PubMed中搜索了研究药物联合运动治疗膝骨关节炎疗效的随机对照试验,Embase,和Cochrane图书馆至2024年2月。网络荟萃分析在频率论框架内进行。估计疼痛和功能的标准化平均差异(SMD),CI为95%。建议的分级,评估,发展,并通过评估来评估证据的确定性。
    总共,包括71项研究。联合疗法优于单独的药理学或运动疗法。在与运动结合的各种药物中,间充质干细胞注射在短期疼痛缓解方面排名最佳(SMD:-1.53,95%CI:-1.92~-1.13,确定性高),其次是肉毒杆菌毒素A,葡萄糖,和富含血小板的血浆.为了长期缓解疼痛,右旋糖复律疗法是最佳的(SMD:-1.76,95%CI:-2.65至-0.88,中等确定性),其次是间充质干细胞,富含生长因子的血小板,和富含血小板的血浆.
    运动计划应纳入临床实践和试验设计。对于接受运动疗法的患者,间充质干细胞,葡萄糖,富血小板血浆,富含生长因子的血小板,和肉毒杆菌毒素A可能是最佳的药物。
    UNASSIGNED: The combination of pharmacological and non-pharmacological interventions is strongly recommended by current guidelines for knee osteoarthritis. However, few systematic reviews have validated their combined efficacy. In this study, we investigated the effects of the combination of pharmacological agents and exercise on knee osteoarthritis.
    UNASSIGNED: Randomized controlled trials that investigated the efficacy of pharmacological agents combined with exercise for knee osteoarthritis were searched in PubMed, Embase, and Cochrane Library up to February 2024. The network meta-analysis was performed within the frequentist framework. Standardized mean difference (SMD) with 95% CI was estimated for pain and function. Grading of recommendations, assessment, development, and evaluations were used to evaluate the certainty of evidence.
    UNASSIGNED: In total, 71 studies were included. The combination therapy outperformed pharmacological or exercise therapy alone. Among the various pharmacological agents combined with exercise, mesenchymal stem cell injection was ranked the best for short-term pain reduction (SMD: -1.53, 95% CI: -1.92 to -1.13, high certainty), followed by botulinum toxin A, dextrose, and platelet-rich plasma. For long-term pain relief, dextrose prolotherapy was the optimal (SMD: -1.76, 95% CI: -2.65 to -0.88, moderate certainty), followed by mesenchymal stem cells, platelet rich in growth factor, and platelet-rich plasma.
    UNASSIGNED: Exercise programs should be incorporated into clinical practice and trial design. For patients undergoing exercise therapies, mesenchymal stem cell, dextrose, platelet-rich plasma, platelet rich in growth factor, and botulinum toxin A may be the optimal agents.
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  • 文章类型: Journal Article
    膝关节是骨关节炎(OA)中最常见的关节,影响着全世界数百万人。膝关节OA显着影响日常生活活动(ADL),同时影响患者的整体生活质量(QoL),从而导致巨大的社会经济负担。保守治疗是优先考虑的,仅在需要时诉诸手术。然而,这些传统方法有局限性。再生医学,涉及直向生物学的使用,包括自体外周血衍生的直系生物制剂,如生长因子浓缩物(GFC),已经进化并显示出治疗膝关节OA的潜力。这篇综述的主要目的是总结体外实验的结果,涉及GFC治疗膝关节OA的临床前和临床研究。
    多个数据库(PubMed、Scopus,谷歌学者,WebofScience和Embase)在2024年3月10日以英语发表的研究中,搜索了干预“GFC”和治疗“膝盖OA”的术语。
    只有三项临床研究符合我们预先定义的标准,并被纳入本综述。
    关节内施用GFC是安全的,并且潜在地有效地管理膝关节的OA。更多,足够的动力,多中心,prospective,RCT有必要证明GFC在轻度至中度膝关节OA患者中的长期有效性,并证明其常规临床使用是合理的。还需要进一步的研究来评估GFC与其他直管生物学相比的功效,以允许医师/外科医生选择治疗膝关节OA的最佳直管生物学。
    UNASSIGNED: The knee is the most commonly affected joint in osteoarthritis (OA), affecting millions of people worldwide. Knee OA significantly impacts the activities of daily living (ADL) along with affecting overall quality of life of patients (QoL), thereby leading to substantial socio-economic burden. Conservative therapies are prioritized, resorting to surgery only when needed. However, these traditional approaches have limitations. Regenerative medicine, involving the use of orthobiologics, including autologous peripheral blood-derived orthobiologics such as growth factor concentrate (GFC), has evolved and shown potential for managing knee OA. The primary goal of this review is to summarize the results of in vitro, preclinical and clinical studies involving GFC for the management of knee OA.
    UNASSIGNED: Multiple databases (PubMed, Scopus, Google Scholar, Web of Science and Embase) were searched applying terms for the intervention \'GFC\' and treatment \'knee OA\' for the studies published in the English language to March 10, 2024.
    UNASSIGNED: Only three clinical studies met our pre-defined criteria and were included in this review.
    UNASSIGNED: Intra-articular administration of GFC is safe and potentially efficacious to manage OA of the knee. More, adequately powered, multi-center, prospective, RCTs are warranted to demonstrate the long-term effectiveness of GFC in patients suffering from mild-to-moderate knee OA and to justify its routine clinical use. Further studies evaluating the efficacy of GFC compared to other orthobiologics are also required to allow physicians/surgeons to choose the optimal orthobiologic for the treatment of OA of the knee.
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  • 文章类型: Journal Article
    膝关节骨性关节炎(OA)是一种普遍存在的、禁用条件,没有干预,以完全恢复软骨或停止进展。骨髓穿刺液浓缩液(BMAC),来自骨髓抽吸的自体产品,由于其细胞组成和软骨形成作用,已显示出作为再生疗法的希望。我们的研究旨在评估功能结果,包括疼痛,函数,满意,膝关节OA患者注射BMAC后的并发症。
    在这个前景中,单中心研究,63例II-III级膝关节OA(Kellgren-Lawrence(K-L)量表)对保守治疗无反应的患者接受了BMAC注射。手术包括从髂前骨穿刺骨髓,加工以获得浓缩物,然后关节内注射。患者随访24个月,使用视觉模拟量表(VAS)评估结果,国际膝关节文献委员会(IKDC)评分,和MOCART2.0评分。
    队列,女性占主导地位,主要年龄在41-50岁,主要包括K-LIII级OA患者。BMAC治疗导致VAS疼痛评分显着改善,IKDC功能评分,在24个月的随访中,MOCART2.0得分。
    BMAC注射在轻度至中度膝关节OA患者的中期随访中提供了疼痛和功能结果的显着改善。进一步的高品质,足够的动力,多中心,prospective,双盲,需要进行随访时间较长的随机对照试验,以证明临床常规使用BMAC治疗膝关节OA患者是合理的.
    UNASSIGNED: Knee osteoarthritis (OA) is a widespread, disabling condition with no intervention to fully restore cartilage or halt progression. Bone marrow aspirate concentrate (BMAC), an autologous product from bone marrow aspiration, has shown promise as a regenerative therapy due to its cell composition and chondrogenic effects. Our study aims to assess the functional outcomes, including pain, function, satisfaction, and complications post-BMAC injection in knee OA patients.
    UNASSIGNED: In this prospective, single-center study, 63 patients with grade II-III knee OA (Kellgren-Lawrence (K-L) scale) unresponsive to conservative management underwent BMAC injection. The procedure involved bone marrow aspiration from the anterior iliac crest, processing to obtain a concentrate, followed by intra-articular injection. Patients were followed for 24 months, assessing outcomes using the Visual Analog Scale (VAS), International Knee Documentation Committee (IKDC) score, and MOCART 2.0 score.
    UNASSIGNED: The cohort, with a slight female predominance and predominantly aged 41-50 years, majorly comprised K-L grade III OA patients. BMAC treatment resulted in significant improvements in VAS pain scores, IKDC functional scores, and MOCART 2.0 scores over the 24-month follow-up.
    UNASSIGNED: BMAC injection provides significant improvement in both pain and functional outcomes at mid-term follow-up in patients with mild-to-moderate OA of the knee. Further high-quality, adequately powered, multi-center, prospective, double-blinded, randomized controlled trials with longer follow-up are necessary to justify the routine clinical use of BMAC for treatment of patients suffering with knee OA.
    UNASSIGNED:
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  • 文章类型: Journal Article
    本文献综述的目的是对现有证据和人工智能在膝骨关节炎中的最新应用进行全面而详尽的概述。
    使用PubMed进行了文献综述,谷歌学者,和IEEE数据库,用于2022年在同行评审期刊上发表的文章。文章重点介绍了人工智能在膝关节骨性关节炎诊断和预后中的应用以及加速图像采集。对于每个选定的研究,代码的可用性,考虑到患者和膝盖的数量,成像类型,协变量,骨关节炎的分级类型,模型,验证方法,目标,并对结果进行了综述。
    筛选了395篇文章,其中35人接受了审查。八篇文章是基于诊断,六论预后预测,关于分类的三个,三对加速图像采集,和15关于膝骨关节炎的分割。57%的文章使用MRI,26%射线照相术,6%MRI与X线照相术,6%的超声检查,只有6%的临床数据。23%的文章为他们的研究提供了计算机代码,26%的人使用了临床数据。17%和14%的文章使用了外部验证和嵌套交叉验证,分别。
    人工智能的使用为增强膝关节骨关节炎的检测和管理提供了有希望的潜力。将开发的模型转化为诊所仍处于开发的早期阶段。预计将在前瞻性研究中进一步研究人工智能模型的翻译,以支持临床医生改善常规医疗保健实践。
    UNASSIGNED: The aim of this literature review is to yield a comprehensive and exhaustive overview of the existing evidence and up-to-date applications of artificial intelligence for knee osteoarthritis.
    UNASSIGNED: A literature review was performed by using PubMed, Google Scholar, and IEEE databases for articles published in peer-reviewed journals in 2022. The articles focusing on the use of artificial intelligence in diagnosis and prognosis of knee osteoarthritis and accelerating the image acquisition were selected. For each selected study, the code availability, considered number of patients and knees, imaging type, covariates, grading type of osteoarthritis, models, validation approaches, objectives, and results were reviewed.
    UNASSIGNED: 395 articles were screened, and 35 of them were reviewed. Eight articles were based on diagnosis, six on prognosis prediction, three on classification, three on accelerated image acquisition, and 15 on segmentation of knee osteoarthritis. 57% of the articles used MRI, 26% radiography, 6% MRI together with radiography, 6% ultrasonography, and 6% only clinical data. 23% of the articles made the computer codes available for their study, and 26% used clinical data. External validation and nested cross-validation were used in 17% and 14% of articles, respectively.
    UNASSIGNED: The use of artificial intelligence provided a promising potential to enhance the detection and management of knee osteoarthritis. Translating the developed models into clinics is still in the early stages of development. The translation of artificial intelligence models is expected to be further examined in prospective studies to support clinicians in improving routine healthcare practice.
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  • 文章类型: Journal Article
    骨关节炎(OA)膝关节患者的身体功能有限,或身体任务和活动的困难可能会导致残疾。本研究旨在通过分析人口统计学的影响,观察膝关节OA患者自我报告和基于表现的身体功能的预测因素,病态,和肌肉损伤因素。
    135名膝关节OA患者参加了这项研究,以使用膝关节损伤和骨关节炎结果评分(KOOS)完成自我报告问卷。在测量基于性能的物理功能时,测量6米的步态速度(6MGS)测试以评估他们的移动性,并进行了5次坐立试验(5STS)评估以评估其平衡。疼痛强度,膝关节伸肌和屈肌的力量,年龄,体重指数(BMI),症状的持续时间,和影像学严重程度也被收集。使用Spearman相关性和逐步多元线性回归来探索自我报告和基于表现的身体功能的关联和预测因素。
    BMI和症状持续时间与自我报告或基于表现的身体功能均无显著相关性。年龄与6MGS呈显著负相关(r2=-0.383,p<0.01),而膝关节伸肌肌力与5STS有中等相关性(r2=-0.528,p<0.01)。在逐步多元线性回归模型中,疼痛强度(β=0.712,p<0.001),膝关节屈肌肌力(β=0.112,p=0.042)与自我报告的日常活动中的身体功能显著相关,占KOOS-PF评分方差的55.0%.膝关节肌肉力量,包括膝关节伸肌(5STS:β=-0.428,p<0.001)和屈肌力量(6MGS:β=0.367,p<0.001),是具有基于性能的物理函数的主要预测因子。
    疼痛强度是自我报告的身体机能的主要危险因素,膝关节屈肌的力量也有贡献。膝关节OA的严重程度,症状持续时间和BMI对身体功能没有影响.然而,膝关节伸肌和屈肌肌力是基于表现的主要预测因子.我们的结果表明,无论人们处于膝关节OA的早期还是晚期,都应将加强股四头肌和腿筋肌力的弱膝关节肌肉视为膝关节OA的优先考虑因素。
    UNASSIGNED: Osteoarthritis (OA) knee patients have limited ability in physical function, or difficulties with physical tasks and activities may develop disability. This study aimed to observe the predictors of self-reported and performance-based physical function in patients with knee OA by analyzing the impacts of demographic, pathological, and muscle impairment factors.
    UNASSIGNED: 135 knee OA patients participated in this study to complete self-reported questionnaires using Knee Injury and Osteoarthritis Outcome Score (KOOS). When measuring performance-based physical function, a 6-meter gait speed (6MGS) test was measured to evaluate their mobility, and a 5-time Sit-to-Stand test (5STS) was assessed to evaluate their balance. Pain intensity, knee extensor and flexor muscle strength, age, body mass index (BMI), durations of symptoms, and radiographic severity were also collected. Spearman correlation and stepwise multiple linear regression were used to explore the association and predictors in self-reported and performance-based physical function.
    UNASSIGNED: BMI and durations of symptoms did not indicate any significant correlation with either self-reported or performance-based physical function. Age is significantly negatively associated with 6MGS (r 2 = -0.383, p < 0.01), while knee extensor muscle strength has a moderate correlation with 5STS (r 2 = -0.528, p < 0.01). In the stepwise multiple linear regression models, pain intensity (β = 0.712, p < 0.001), knee flexor muscle strength (β = 0.112, p = 0.042) were significantly associated with self-reported physical function in daily activities and contributed to 55.0% of the variance in KOOS-PF score. Knee muscle strength, including knee extensor (5STS: β = -0.428, p < 0.001) and flexor muscle strength (6MGS: β = 0.367, p < 0.001), were the main predictors with performance-based physical function.
    UNASSIGNED: Pain intensity was the leading risk factor of self-reported physical function, and knee flexor muscle strength contributed as well. The severity of knee OA, durations of symptoms and BMI did not contribute to physical function. However, knee extensor and flexor muscle strength were the main predictors of performance-based performance. Our results show that strengthening of weak knee muscles in both quadriceps and hamstring muscle strength should be considered a priory consideration in knee OA no matter if people are in the early or end-stage of knee OA.
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  • 文章类型: Journal Article
    射频消融是膝骨关节炎对症治疗的有效治疗方式。我们的目的是比较射频消融上内侧和下内侧膝神经(2支)与上外侧神经的疗效,超内侧,和膝下神经(3个分支),并显示2个分支程序是否劣于3个分支程序。
    这项研究是一项前瞻性研究,随机化,单盲临床研究。符合条件的参与者被随机分为2组:A组,将该程序应用于上内侧和下内侧膝神经,B组,把它应用到上腹部,上外侧和下内侧膝神经。用数字评定量表评估疼痛,使用简短表格36(SF-36)的生活质量,和残疾与西安大略省和麦克马斯特大学(WOMAC)骨关节炎指数之前,手术后1个月和3个月。
    共纳入41例患者。除了基线时的SF-36身体健康评分外,两组之间没有差异。数字评定量表(NRS)评分有显著改善,SF-36子分数,WOMAC指数总计,以及两组的疼痛和身体功能评分,尽管在随访期间两组之间没有发现显着差异。
    尽管我们无法确定应用于2个分支的常规射频消融(CRFA)与应用于3个分支的CRFA的非劣效性,在这次审判中,在NRS中观察到显著和类似的改善,WOMAC总数,疼痛,两组的身体功能和SF-36评分。
    UNASSIGNED: Radiofrequency ablation is an effective treatment modality in the symptomatic treatment of knee osteoarthritis. Our aim was to compare the efficacy of radiofrequency ablation of the superomedial and inferomedial genicular nerves (2 branches) with the superolateral, superomedial, and inferomedial genicular nerves (3 branches) and to show whether the 2-branch procedure is inferior to the 3-branch procedure.
    UNASSIGNED: This study is a prospective, randomized, single-blind clinical study. Eligible participants were randomized into 2 groups: group A, which applied the procedure to the superomedial and inferomedial genicular nerves, and group B, which applied it to the superomedial, superolateral and inferomedial genicular nerves. Pain was evaluated with the numerical rating scale, quality of life with the Short Form-36 (SF-36), and disability with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index before, and at 1 and 3 months after the procedure.
    UNASSIGNED: A total of 41 patients were included. There were no differences between the groups except for the SF-36 physical health sub-score at baseline. A significant improvement was seen in the numeric rating scale (NRS) score, SF-36 sub-scores, WOMAC Index total, as well as pain and physical function scores in both groups, though no significant difference was detected between the groups during follow-up.
    UNASSIGNED: Although we were unable to establish the noninferiority of conventional radiofrequency ablation (CRFA) applied to 2 branches to CRFA applied to 3 branches, in this trial, significant and similar improvement was observed in NRS, WOMAC total, pain, and physical function and SF-36 scores in both groups.
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  • 文章类型: Journal Article
    背景:全膝关节置换术(TKA)在美国每年对大约790,000名患者进行,预计到2050年将增加到150万。这项研究旨在通过分析评估术前冷冻神经溶解在接受TKA的患者中的使用:1)疼痛严重程度;2)阿片类药物的使用;3)功能状态;和4)出院后6个月内的睡眠障碍。
    方法:在2021年9月至2024年2月期间参加遗传学结果登记创新(iGOR)的患者随访6个月。我们的分析包括接受单侧原发性TKA但没有术前阿片类药物处方的患者,或者没有收到,冷冻神经裂解。在TKA之前收集基线患者人口统计学并制成表格。通过疼痛严重程度的简短疼痛清单(BPI-SF)工具评估疼痛管理。使用患者报告结果测量信息系统(PROMIS)问卷测量睡眠障碍。在TKA之前评估每个结果指标,每周,每月随访。通过广义线性混合效应回归模型分析数据,以比较冷冻神经溶解与对照患者,P<0.05为显著。
    结果:有80例患者接受了术前冷冻神经溶解治疗,而60名对照患者没有接受治疗。在6个月的随访中,接受冷冻神经溶解的患者的疼痛严重程度和睡眠障碍明显低于对照组患者(P=0.046)。冷冻神经溶解还与功能改善趋势相关,但未达到统计学意义(P=0.061)。Further,接受冷冻神经溶解的患者在出院后6个月内服用阿片类药物的可能性比对照组低72%(P<0.001).
    结论:接受TKA的阿片类药物初治患者的术前冷冻神经溶解治疗与疼痛改善有关,减少阿片类药物的使用,术后6个月睡眠障碍得到改善。冷冻神经裂解,术前给予非阿片类疼痛缓解方式,在接受TKA的患者中显示出实质性的益处。
    BACKGROUND: Total knee arthroplasty (TKA) is performed on approximately 790,000 patients annually in the United States and is projected to increase to 1.5 million by 2050. This study aimed at assessing the use of preoperative cryoneurolysis on patients undergoing TKA by analyzing: 1) pain severity; 2) opioid use; 3) functional status; and 4) sleep disturbance over 6 months following discharge.
    METHODS: Patients enrolled in the Innovations in Genicular Outcomes Registry (iGOR) between September 2021 and February 2024 were followed for 6 months. Our analyses included patients undergoing unilateral primary TKA with no pre-operative opioid prescription who either received, or did not receive, cryoneurolysis. Baseline patient demographics were collected before TKA and tabulated. Pain management was assessed via the Brief Pain Inventory-Short Form (BPI-SF) instrument for pain severity. Sleep disturbance was measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. Each outcome measure was assessed prior to TKA, weekly, and at monthly follow-up. Data was analyzed by a generalized linear mixed-effect regression model to compare cryoneurolysis versus control patients, with a P < 0.05 as significant.
    RESULTS: There were 80 patients who were treated with preoperative cryoneurolysis, while 60 control patients did not have treatment. Patients receiving cryoneurolysis experienced significantly lower pain severity and sleep disturbance over the 6-month follow-up than control patients (P = 0.046). Cryoneurolysis was also associated with a trend toward greater functional improvement that did not reach statistical significance (P = 0.061). Further, patients who underwent cryoneurolysis were 72% less likely than controls to take opioids over six months following discharge (P <0.001).
    CONCLUSIONS: Pre-operative cryoneurolysis therapy in opioid-naïve patients undergoing TKA is associated with improved pain, decreased opioid use, and improved sleep disturbance for 6 months postoperatively. Cryoneurolysis, a non-opioid pain relief modality administered pre-operatively, demonstrated substantial benefits in patients who underwent TKA.
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  • 文章类型: Journal Article
    背景:骨关节炎(OA)是一种致残疾病,影响65岁以上人群的三分之一以上。目前,这些患者中有80%报告运动受限,20%的人无法进行主要的日常生活活动,大约11%需要个人护理。2014年,欧洲骨质疏松症和骨关节炎临床和经济方面协会(ESCEO)建议,作为膝骨关节炎药物治疗的第一步,使用慢性有症状的缓慢作用的骨关节炎药物如硫酸葡糖胺的背景疗法,硫酸软骨素,和透明质酸。后者已在临床试验中广泛评估为关节内和口服给药。最近的评论表明,对口服透明质酸的研究通常仅使用主观参数来测量症状,如视觉模拟量表或生活质量问卷。因此,缺乏客观措施,数据有效性通常会受到损害。
    目的:这项使用口服透明质酸的初步研究的主要目标是评估使用客观工具作为评估膝关节活动度改善的结果的可行性。我们建议使用测角仪进行超声和运动范围测量,该测角仪可以客观地将关节活动度的变化与疼痛减轻相关联,通过视觉模拟量表评估。次要目标是收集数据以估计主要双盲研究随机试验的时间和预算。这些数据可能是定量的(例如每月的入学率,筛选失败的数量,和新的潜在结果)和定性(如现场后勤问题,患者不愿参加,和调查人员的人际关系困难)。
    方法:这项开放标签的试点和可行性研究是在骨科诊所进行的(Timisoara,罗马尼亚)。这项研究包括男性和女性参与者,50-70岁,已被诊断为有症状的膝关节OA,并经历了至少6个月的轻度关节不适。必须招募八名患者并用Syalox300Plus(RiverPharma)治疗8周。它是一种含有高分子量透明质酸的膳食补充剂,它已经在几个欧洲国家销售。在基线和最终访问时进行评估。
    结果:8名患者的招募和治疗于2018年2月15日开始,并于2018年5月25日完成。数据分析计划于2018年底完成。该研究于2019年2月获得资助。我们预计这些结果将在2024年最后一个季度发表在同行评审的临床期刊上。
    结论:这项初步研究的数据将用于评估未来OA随机临床试验的可行性。特别是,计划的结果(例如,超声和运动范围),安全,并且必须对定量和定性数据进行评估,以提前估算未来主要研究所需的时间和预算。最后,试点研究应提供有关研究产品疗效的初步信息.
    背景:ClinicalTrials.govNCT03421054;https://clinicaltrials.gov/study/NCT03421054。
    RR1-10.2196/13642。
    BACKGROUND: Osteoarthritis (OA) is a disabling condition that affects more than one-third of people older than 65 years. Currently, 80% of these patients report movement limitations, 20% are unable to perform major activities of daily living, and approximately 11% require personal care. In 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommended, as the first step in the pharmacological treatment of knee osteoarthritis, a background therapy with chronic symptomatic slow-acting osteoarthritic drugs such as glucosamine sulfate, chondroitin sulfate, and hyaluronic acid. The latter has been extensively evaluated in clinical trials as intra-articular and oral administration. Recent reviews have shown that studies on oral hyaluronic acid generally measure symptoms using only subjective parameters, such as visual analog scales or quality of life questionnaires. As a result, objective measures are lacking, and data validity is generally impaired.
    OBJECTIVE: The main goal of this pilot study with oral hyaluronic acid is to evaluate the feasibility of using objective tools as outcomes to evaluate improvements in knee mobility. We propose ultrasound and range of motion measurements with a goniometer that could objectively correlate changes in joint mobility with pain reduction, as assessed by the visual analog scale. The secondary objective is to collect data to estimate the time and budget for the main double-blind study randomized trial. These data may be quantitative (such as enrollment rate per month, number of screening failures, and new potential outcomes) and qualitative (such as site logistical issues, patient reluctance to enroll, and interpersonal difficulties for investigators).
    METHODS: This open-label pilot and feasibility study is conducted in an orthopedic clinic (Timisoara, Romania). The study includes male and female participants, aged 50-70 years, who have been diagnosed with symptomatic knee OA and have experienced mild joint discomfort for at least 6 months. Eight patients must be enrolled and treated with Syalox 300 Plus (River Pharma) for 8 weeks. It is a dietary supplement containing high-molecular-weight hyaluronic acid, which has already been marketed in several European countries. Assessments are made at the baseline and final visits.
    RESULTS: Recruitment and treatment of the 8 patients began on February 15, 2018, and was completed on May 25, 2018. Data analysis was planned to be completed by the end of 2018. The study was funded in February 2019. We expect the results to be published in a peer-reviewed clinical journal in the last quarter of 2024.
    CONCLUSIONS: The data from this pilot study will be used to assess the feasibility of a future randomized clinical trial in OA. In particular, the planned outcomes (eg, ultrasound and range of motion), safety, and quantitative and qualitative data must be evaluated to estimate in advance the time and budget required for the future main study. Finally, the pilot study should provide preliminary information on the efficacy of the investigational product.
    BACKGROUND: ClinicalTrials.gov NCT03421054; https://clinicaltrials.gov/study/NCT03421054.
    UNASSIGNED: RR1-10.2196/13642.
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  • 文章类型: Journal Article
    背景:膝关节骨性关节炎(OA)影响了19%的45岁以上的美国成年人,每年花费270亿美元。广泛的非手术治疗方案是可用的。这项研究比较了六种治疗方法:冷冻神经溶解与深膝状神经阻滞(冷冻深/两者),浅表神经阻滞冷冻神经溶解术(冷冻浅表),关节内透明质酸(IA-HA)注射,非甾体抗炎药注射剂(IA-NSAIDs),IA-皮质类固醇(IA-CS)注射,或在4个月内注射IA-曲安奈德缓释(IA-TA-ER),用于:1)疼痛严重程度和镇痛使用;和2)身体功能(来自膝关节损伤和骨关节炎的关节置换结果评分(KOOS,JR))。
    方法:单侧膝关节OA并接受非手术干预的患者被纳入遗传结果创新(iGOR)登记,一本小说,多中心真实世界注册表,2021年9月至2024年2月。共纳入480例患者。在基线时评估疼痛和功能结果。每周,每月,分析为:总体趋势,治疗前后的幅度变化,和基于分布的最小临床重要差异评分(MCID)。对7个混杂因素进行校正的多变量线性回归用于比较6个治疗组的随访结果。
    结果:使用IA-TA-ER注射与最低疼痛相关,最大的疼痛减轻,与其他治疗相比,达到MCID的患者患病率最高(P<0.001)。Deep/Both-Cryo和IA-CS与实现MCID的患病率高于IA-HA相关,IA-NSAIDs,和低温表面(P≤0.001)。IA-TA-ER的使用也与最大的功能评分相关,从基线改进,与其他治疗相比,达到MCID的患者患病率最高(P≤0.003)。
    结论:在治疗后4个月内,IA-TA-ER在疼痛缓解和功能改善方面似乎优于其他治疗。此外,新型冷冻神经溶解和常规IA-CS的结局相似,且优于IA-HA和IA-NSAIDs.
    BACKGROUND: Knee osteoarthritis (OA) affects 19% of American adults over 45 years old and costs $27+ billion annually. A wide range of non-operative treatment options are available. This study compared six treatments: cryoneurolysis with deep genicular nerve block (Cryo-Deep/Both), cryoneurolysis with superficial nerve block (Cryo-Superficial), intra-articular hyaluronic acid (IA-HA) injections, non-steroidal anti-inflammatory drug injections (IA-NSAIDs), IA-corticosteroids (IA-CS) injections, or IA-triamcinolone extended release (IA-TA-ER) injections over 4 months for: 1) pain severity and analgesic use; and 2) physical function (from Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)).
    METHODS: Patients who had unilateral knee OA and received non-operative intervention were enrolled in the Innovations in Genicular Outcomes (iGOR) registry, a novel, multi-center real-world registry, between September 2021 and February 2024. A total of 480 patients were enrolled. Both pain and functional outcomes were assessed at baseline, weekly, and monthly, which were analyzed by: overall trend, magnitude changes pre- to post-treatment, and distribution-based minimal clinically important difference score (MCID). Multivariate linear regressions with adjustments for seven confounding factors were used to compare follow-up outcomes among six treatment groups.
    RESULTS: Use of IA-TA-ER injections was associated with the lowest pain, greatest pain reduction, and highest prevalence of patients achieving MCID relative to other treatments (P < 0.001). Deep/Both-Cryo and IA-CS were associated with a higher prevalence of achieving MCID than IA-HA, IA-NSAIDs, and Cryo-Superficial (P ≤ 0.001). Use of IA-TA-ER was also associated with the greatest functional score, improvement from baseline, and highest prevalence of patients achieving MCID than other treatments (P ≤ 0.003).
    CONCLUSIONS: The IA-TA-ER appears to outperform other treatments in terms of pain relief and functional improvement for up to 4 months following treatment. In addition, outcomes in the novel cryoneurolysis and conventional IA-CS were similar to one another and better than those in IA-HA and IA-NSAIDs.
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