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HIGH-RESOLUTION 3D IMAGING OF BOVINE TAIL INTERVERTEBRAL DISC DEGENERATION USING IODINE-ENHANCED X-RAY MICROSCOPY 利用碘增强x射线显微镜对牛尾椎间盘退变进行高分辨率三维成像
Osteoarthritis imaging
Pub Date : 2025-01-01 DOI: 10.1016/j.ostima.2025.100307
V. Peitso, S. Das Gupta, S. Kauppinen, M. Risteli, M. Finnilä, A. Mobasheri

INTRODUCTION

The vertebral endplates of the intervertebral disc (IVD) consist of two structurally distinct layers: the cartilaginous endplate (CEP) and the bony endplate (BEP). While most research on IVD degeneration has focused on the biochemical or biomechanical failures of the annulus fibrosus (AF) and nucleus pulposus (NP), the physiology and microstructure of the CEP have often been overlooked. To address this gap, we employed iodine-enhanced X-ray microscopy (XRM) in a bovine tail IVD degeneration model. This approach enabled the simultaneous visualization of soft and hard tissues, with a specific focus on the CEP.

OBJECTIVE

1) To simultaneously visualize soft and hard tissues in IVDs, with a specific focus on detecting changes in the CEP using iodine-enhanced XRM. 2) To validate the observed structural changes through histological analysis.

METHODS

34 IVDs with intact vertebral endplates were harvested from six fresh bovine tails. Samples were cultured in Dulbecco’s Modified Eagle Medium (DMEM) for 11 days under unloaded conditions. On day one, approximately 70-100 μL of chondroitinase ABC (chABC, 0.5 U/mL), a pro-inflammatory cytokine cocktail containing interleukin-1β (IL-1β) and tumor necrosis factor alpha (TNF-α) (each at 100 ng/mL), or a sham control solution of phosphate-buffered saline (PBS) with 0.1% bovine serum albumin (BSA) was injected into the NP using a 21G needle. Additional control samples received no injection. On day 11, IVDs were fixed in 4% formaldehyde and dehydrated. Samples were immersed in 1% (w/v) iodine (I2) in 100% ethanol and stained for a minimum of two weeks. Following staining, samples were washed, embedded in 1% agarose, and imaged with an XRM (Zeiss Xradia Versa 610; source voltage: 60kV; exposure: 4-6 sec; voxel size: 9.9-15.6 µm). Post-imaging, iodine was removed, and samples were decalcified and paraffin-embedded. Thin sections (7-10 µm) were prepared and stained with hematoxylin and eosin (H&E) and safranin-O and fast green. Reconstituted XRM image stacks were processed using built-in noise filtering software (Zeiss). Dragonfly 3D world (Comet) software was used for visualization and segmentation. XRM images were qualitatively compared with histological sections to assess changes in soft and hard tissues (Figures 1 and 2).

RESULTS

The interface between mineralized and non-mineralized cartilage (tidemark) was visualized using XRM, enabling the identification of calcified cartilage and CEP (Figure 1). Iodine-based contrast provided sufficient resolution to detect structural malalignments among the BEP, CEP, and NP (Figure 2). Notably, even sham injections with PBS induced degenerative changes in the disc.

CONCLUSION

Non-destructive iodine-enhanced XRM enables clear visualization of the CEP, providing sufficient contrast to simultaneously assess structural cha
椎间盘终板（IVD）由两层结构不同的椎体终板组成：软骨终板（CEP）和骨终板（BEP）。虽然大多数关于IVD退变的研究都集中在纤维环（AF）和髓核（NP）的生化或生物力学失效上，但CEP的生理和微观结构往往被忽视。为了解决这一差距，我们在牛尾IVD变性模型中使用了碘增强x射线显微镜（XRM）。该方法能够同时显示软硬组织，并特别关注CEP。目的1)同时显示ivd中的软硬组织，特别关注使用碘增强XRM检测CEP的变化。2)通过组织学分析验证观察到的结构变化。方法从6只新鲜牛尾中取出34只具有完整椎终板的ivd。样品在Dulbecco 's Modified Eagle Medium （DMEM）中脱模培养11天。第一天，用21G针将约70-100 μL的软骨素酶ABC （chABC, 0.5 U/mL）、含有白细胞介素-1β (IL-1β)和肿瘤坏死因子α (TNF-α)的促炎细胞因子鸡尾酒（各100 ng/mL）或含有0.1%牛血清白蛋白（BSA）的磷酸盐缓冲盐水（PBS）假对照溶液注射到NP中。另外的对照样本没有注射。第11天，将ivd固定在4%甲醛中并脱水。样品浸泡在1% （w/v）碘（I2）和100%乙醇中，染色至少两周。染色后，清洗样品，包埋在1%琼脂糖中，用XRM成像(蔡司Xradia Versa 610；源电压：60kV；曝光：4-6秒；体素尺寸：9.9-15.6µm)。成像后，去除碘，样品脱钙并包埋石蜡。制备7-10µm薄片，用苏木精和伊红（H&；E）、藏红花素- o和快绿染色。重建的XRM图像堆栈使用内置的噪声滤波软件（蔡司）进行处理。使用Dragonfly 3D world （Comet）软件进行可视化和分割。将XRM图像与组织学切片进行定性比较，评估软硬组织的变化（图1和2）。结果XRM显示了矿化软骨和非矿化软骨之间的界面（潮汐标记），可以识别钙化软骨和CEP（图1）。基于碘的对比提供了足够的分辨率来检测BEP、CEP和NP之间的结构失调（图2）。值得注意的是，即使是假注射PBS也会引起椎间盘的退行性改变。结论非破坏性碘增强XRM能够清晰地显示CEP，提供足够的对比，同时评估软硬组织的结构变化。这种方法为评估体外模型的IVD退化提供了强有力的工具。
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引用次数: 0
EX VIVO IMAGING OF DIFFERENT CALCIFICATION TYPES IN POSTERIOR HORN OF HUMAN MENISCUS USING MICRO-COMPUTED TOMOGRAPHY 人半月板后角不同钙化类型的体外显微计算机断层成像
Osteoarthritis imaging
Pub Date : 2025-01-01 DOI: 10.1016/j.ostima.2025.100296
V.P. Karjalainen , I. Hellberg , A. Turkiewicz , B. Shakya , N. Khoshimova , E. Nevanranta , K. Elkhouly , S. Das Gupta , A. Sjögren , M.A.J. Finnilä , P. Önnerfjord , V. Hughes , J. Tjörnstrand , M. Englund , S. Saarakkala

INTRODUCTION

Meniscal calcifications are known to be associated with OA. Specifically, two types of calcifications have been commonly identified in osteoarthritic knees: basic calcium phosphate (BCP) and calcium pyrophosphate (CPP). However, their pathological significance remains largely unclear. Characterizing differences between the calcification types and their deposition patterns inside the meniscus could help in their identification with in vivo imaging modalities and provide a better understanding of the role of meniscal calcifications in the OA disease process.

OBJECTIVE

1) Identify the two different types of calcifications in human meniscus ex vivo in 3D using µCT; 2) Describe the different deposition patterns observed in BCP and CPP calcifications.

METHODS

From the MENIX biobank in Lund, Sweden, we collected 82 posterior horns of medial and lateral menisci from 20 total knee replacement (TKR) patients and 21 deceased donors (50/50% female/male, average age 71 years) for the study. A 5-mm-thick subsection was dissected from the posterior horn, fixed in formalin, dehydrated, and treated with hexamethyldisilazane (HMDS) before air-drying at room temperature overnight. Subsequently, the HMDS-treaded section was imaged with a desktop µCT imaging (SkyScan 1272, Bruker, micro-CT) with the following settings: 60 kV, 166 µA, 2.0 µm voxel size, 3500 ms exposure time, random movement 25 voxels, and without an additional filter. Two different image reconstruction settings were used to maximize the image quality of meniscal soft tissue and calcifications. Pieces of meniscus adjacent to the µCT underwent histological processing and Alizarin Red staining. Calcification types from the histological sections were identified using Raman micro-spectroscopy.

RESULTS

We successfully imaged both meniscal calcification types together with soft tissue in 3D using high-resolution µCT (Figure 1). Based on Raman spectral analysis, out of the 82 menisci, 39 had at least one calcification: 28 had BCP calcifications, 8 had CPP calcifications, and 3 had both. In µCT, BCP calcifications were quantitatively denser, morphologically sharper, more punctuated, smaller in size as well as number, and more spherical than CPPs. Unlike CPPs, BCPs were mainly deposited in the periphery of meniscal tissue, inside complex 3D tears or fibrillations. In contrast, the CPP calcifications formed long rod-like structures, mainly inside the meniscal tissue.

CONCLUSION

Based on the 3D µCT images, BCP calcifications were not found inside the meniscal tissue but in the peripheral area. This could suggest that larger clusters of BCP calcifications found in the meniscus come from the synovial fluid and possibly originate from articular cartilage or bone. Meanwhile, the likely place for CPPs to accumulate and expand within the meniscal tissue is
半月板钙化已知与OA有关。具体来说，两种类型的钙化已被普遍认定为骨关节炎膝关节：碱性磷酸钙（BCP）和焦磷酸钙（CPP）。然而，它们的病理意义在很大程度上仍不清楚。表征半月板内钙化类型及其沉积模式的差异有助于半月板钙化与体内成像模式的识别，并更好地了解半月板钙化在OA疾病过程中的作用。目的1)利用微CT识别人半月板离体三维钙化的两种不同类型；2)描述BCP和CPP钙化的不同沉积模式。方法：研究人员从瑞典隆德MENIX生物银行收集了20例全膝关节置换术（TKR）患者和21例已故供体（男女各占50/50%，平均年龄71岁）的82个内侧和外侧半月板后角。从后角上解剖一个5mm厚的分段，用福尔马林固定，脱水，用六甲基二氮杂烷（HMDS）处理，然后在室温下风干过夜。随后，使用桌面微CT成像（SkyScan 1272, Bruker, micro-CT）对hmds处理的切片进行成像，设置如下：60 kV， 166µa， 2.0µm体素大小，3500 ms曝光时间，随机移动25体素，没有额外的过滤器。采用两种不同的图像重建设置，以最大限度地提高半月板软组织和钙化的图像质量。微CT旁半月板切片进行组织学处理和茜素红染色。组织切片的钙化类型用拉曼显微光谱鉴定。我们使用高分辨率微CT成功地对两种半月板钙化类型以及软组织进行了三维成像（图1）。根据拉曼光谱分析，在82例半月板中，39例至少有一种钙化，28例有BCP钙化，8例有CPP钙化，3例两者都有。在µCT上，BCP钙化密度更大，形态更清晰，标点更多，尺寸和数量更小，比CPPs更球形。与CPPs不同，bcp主要沉积在半月板组织的周围、复杂的3D撕裂或纤颤内。相反，CPP钙化形成长棒状结构，主要在半月板组织内。结论三维微CT图像显示，半月板组织内未见BCP钙化，周围可见BCP钙化。这可能提示半月板内较大的BCP钙化团来自滑液，也可能来自关节软骨或骨。同时，CPPs在半月板组织内可能积聚和扩张的位置是在沿周向胶原纤维束的流体通道中，在那里它们填充通道的腔体形成棒状形态，并持续供应钙和其他成分。此外，血管壁被观察到积累钙化，由不跟随周围纤维的空心杆状结构支撑。在半月板撕裂和退化后，CPPs可能开始以无定形模式积聚在半月板表面和撕裂处。这种半月板钙化模式的定性三维比较可能有助于在未来更容易地与成像方式区分它们，以及更好地了解它们在OA中的作用。
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引用次数: 0
FEASIBILITY OF NON-CONTRAST MRI TO DETECT CHANGES IN SYNOVITIS AFTER ACL RECONSTRUCTION SURGERY 非对比mri检测前交叉韧带重建术后滑膜炎变化的可行性
Osteoarthritis imaging
Pub Date : 2025-01-01 DOI: 10.1016/j.ostima.2025.100298
F. Kogan , K. Stevens , A. Williams , C. Chu

INTRODUCTION

Synovitis is a recognized risk factor for post-traumatic osteoarthritis post-ACL reconstruction (ACLR). The reference standard for imaging synovitis is contrast enhanced MRI, but this adds time and cost and may be contraindicated in some patients, which may limit evaluation of this important finding. Recently, several non-contrast MRI methods have shown strong agreement with CE-MRI for semiquantitative assessment of synovitis.

OBJECTIVE

To evaluate the feasibility of quantitative double-echo in steady-state (qDESS) as a non-contrast MR technique to detect changes in synovitis in patients pre- and post-ACLR.

METHODS

14 males and 4 females (age:27±6 years, BMI:24±3 kg/m2) with ACL tears underwent ACLR surgery (mean time from injury to surgery 10±5 weeks) and were scanned on a 3T MR scanner at three timepoints: (1) baseline post ACL tear but before reconstruction, (2) 6-weeks and (3) 6-months after ACLR. At each time point, a 3D qDESS acquisition was performed with parameters: TR/TE1/TE2 = 20.5/6.4/34.6 ms; acquisition resolution = 0.4 × 0.4 × 1.5 mm3; 80 slices; Flip Angle = 20. qDESS synovitis hybrid images were created by a weighted subtraction of the 2nd echo signal from the 1st echo to null signal from joint fluid in order to provide contrast to the synovium. Synovitis was scored in the knee overall and in 4 regional locations by a blinded radiologist on a scale of 0-3 (0 = none to 3 = severe).

RESULTS

Figure 1 shows a representative case of qDESS synovitis-weighted hybrid images at the three timepoints and their corresponding scores. Figure 2a shows a table of the % of patients (out of 18) that were scored to have improved or worsened synovitis between baseline and 6-weeks post-ACLR and between 6-weeks and 6-months post-ACLR. Overall, there was a clear trend towards synovitis worsening 6-weeks after ACLR and then improving between 6-weeks and 6-months post-surgery. Furthermore, when the 6-week and 6-month timepoints for each patient were compared directly but blinded to order, an improvement in assessed synovitis was observed in a further 82% of overall impressions that were previously scored as no change in blinded and randomized assessments (Figure 2b). Repeated synovitis scoring assessments showed very strong agreement (Gwets AC2>0.80) in overall and sub-region assessments.

DISCUSSION

While ground-truth synovitis measures were not available, the qDESS hybrid method was able to detect both worsening synovitis that is expected after ACLR surgery and improvement in synovitis that is expected during the following 5 months of recovery. The lack of differentiation of synovitis changes between timepoints may partly be attributed to the coarseness of the 4-point semi-quantitative Likert-scale which is based on synovial hypertrophy and nodularity In overall a
滑膜炎是公认的创伤后骨关节炎后acl重建（ACLR）的危险因素。滑膜炎成像的参考标准是对比增强MRI，但这增加了时间和成本，并且可能在某些患者中是禁忌的，这可能限制了对这一重要发现的评估。最近，几种非对比MRI方法与CE-MRI在滑膜炎半定量评估方面表现出强烈的一致性。目的评价定量稳态双回声（qDESS）作为非对比磁共振技术检测aclr前后滑膜炎变化的可行性。方法14名男性和4名女性ACL撕裂患者（年龄：27±6岁，BMI:24±3 kg/m2）接受ACLR手术（平均从损伤到手术时间10±5周），并在三个时间点(1)ACL撕裂后重建前的基线，(2)ACLR后6周和(3)ACLR后6个月在3T MR扫描仪上扫描。在每个时间点进行三维qDESS采集，参数为：TR/TE1/TE2 = 20.5/6.4/34.6 ms；采集分辨率 = 0.4 × 0.4 × 1.5 mm3；80片;翻转角度 = 20。qDESS滑膜炎混合图像是通过将第2回波信号从第1回波加权减去关节液的零信号来创建的，以便提供滑膜的对比度。滑膜炎由盲法放射科医生评分，评分范围为0-3（0 = 无滑膜炎至3 = 严重滑膜炎）。结果图1显示了三个时间点上qDESS滑膜加权混合图像的代表性病例及其相应的评分。图2a显示了在基线至aclr后6周以及aclr后6周至6个月期间滑膜炎改善或恶化的患者百分比（18名患者中）的表格。总体而言，ACLR术后6周滑膜炎有明显的恶化趋势，术后6周至6个月滑膜炎有所改善。此外，当对每个患者的6周和6个月时间点进行直接比较时，盲法排序，评估的滑膜炎的改善在另外82%的总体印象中被观察到，之前在盲法和随机评估中被评为没有变化（图2b）。重复的滑膜炎评分评估在总体和分区域评估中显示出非常强的一致性（Gwets AC2>0.80）。虽然没有真正的滑膜炎测量方法，但qDESS混合方法能够检测ACLR手术后预期的滑膜炎恶化和随后5个月恢复期间预期的滑膜炎改善。滑膜炎变化在不同时间点之间缺乏区分可能部分归因于4点半定量李克特量表的粗糙性，该量表基于滑膜肥大和结节性，在总体和区域评估中，当在随机和盲法数据集中传统4点量表中未检测到变化时，随后对每个参与者的6周和6个月时间点进行直接比较。放射科医生能够发现改善滑膜炎在大多数情况下，尽管是盲目的时间点。值得注意的例外是在椎间切迹处，滑膜炎的评估与沿Hoffa脂肪垫的手术改变相混淆，可能导致高估该区域滑膜炎的程度。最后，总体印象和区域评估的再现性协议指标显示出强烈的一致性，进一步支持了该方法的潜在效用。结论：使用qDESS方法进行滑膜炎的非对比MRI检查能够检测到aclr后和恢复期间滑膜炎的变化，特别是当直接比较受试者内时间点时。这种方法显示了新的诊断潜力，可以识别因慢性炎症而有患上睑下垂风险的患者，并有可能用于监测治疗效果。
{"title":"FEASIBILITY OF NON-CONTRAST MRI TO DETECT CHANGES IN SYNOVITIS AFTER ACL RECONSTRUCTION SURGERY","authors":"F. Kogan ,&nbsp;K. Stevens ,&nbsp;A. Williams ,&nbsp;C. Chu","doi":"10.1016/j.ostima.2025.100298","DOIUrl":"10.1016/j.ostima.2025.100298","url":null,"abstract":"<div><h3>INTRODUCTION</h3><div>Synovitis is a recognized risk factor for post-traumatic osteoarthritis post-ACL reconstruction (ACLR). The reference standard for imaging synovitis is contrast enhanced MRI, but this adds time and cost and may be contraindicated in some patients, which may limit evaluation of this important finding. Recently, several non-contrast MRI methods have shown strong agreement with CE-MRI for semiquantitative assessment of synovitis.</div></div><div><h3>OBJECTIVE</h3><div>To evaluate the feasibility of quantitative double-echo in steady-state (qDESS) as a non-contrast MR technique to detect changes in synovitis in patients pre- and post-ACLR.</div></div><div><h3>METHODS</h3><div>14 males and 4 females (age:27±6 years, BMI:24±3 kg/m<sup>2</sup>) with ACL tears underwent ACLR surgery (mean time from injury to surgery 10±5 weeks) and were scanned on a 3T MR scanner at three timepoints: (1) baseline post ACL tear but before reconstruction, (2) 6-weeks and (3) 6-months after ACLR. At each time point, a 3D qDESS acquisition was performed with parameters: TR/TE1/TE2 = 20.5/6.4/34.6 ms; acquisition resolution = 0.4 × 0.4 × 1.5 mm<sup>3</sup>; 80 slices; Flip Angle = 20. qDESS synovitis hybrid images were created by a weighted subtraction of the 2<sup>nd</sup> echo signal from the 1<sup>st</sup> echo to null signal from joint fluid in order to provide contrast to the synovium. Synovitis was scored in the knee overall and in 4 regional locations by a blinded radiologist on a scale of 0-3 (0 = none to 3 = severe).</div></div><div><h3>RESULTS</h3><div>Figure 1 shows a representative case of qDESS synovitis-weighted hybrid images at the three timepoints and their corresponding scores. Figure 2a shows a table of the % of patients (out of 18) that were scored to have improved or worsened synovitis between baseline and 6-weeks post-ACLR and between 6-weeks and 6-months post-ACLR. Overall, there was a clear trend towards synovitis worsening 6-weeks after ACLR and then improving between 6-weeks and 6-months post-surgery. Furthermore, when the 6-week and 6-month timepoints for each patient were compared directly but blinded to order, an improvement in assessed synovitis was observed in a further 82% of overall impressions that were previously scored as no change in blinded and randomized assessments (Figure 2b). Repeated synovitis scoring assessments showed very strong agreement (Gwets AC2&gt;0.80) in overall and sub-region assessments.</div></div><div><h3>DISCUSSION</h3><div>While ground-truth synovitis measures were not available, the qDESS hybrid method was able to detect both worsening synovitis that is expected after ACLR surgery and improvement in synovitis that is expected during the following 5 months of recovery. The lack of differentiation of synovitis changes between timepoints may partly be attributed to the coarseness of the 4-point semi-quantitative Likert-scale which is based on synovial hypertrophy and nodularity In overall a","PeriodicalId":74378,"journal":{"name":"Osteoarthritis imaging","volume":"5 ","pages":"Article 100298"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144521548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
FROM MENISCAL DEGENERATION TO OSTEOARTHRITIS: TRACKING EARLY DISEASE PROGRESSION WITH MRI-BASED COMPOSITE SCORES: DATA FROM THE OSTEOARTHRITIS INITIATIVE 从半月板变性到骨关节炎：用基于mri的复合评分跟踪早期疾病进展：来自骨关节炎倡议的数据
Osteoarthritis imaging
Pub Date : 2025-01-01 DOI: 10.1016/j.ostima.2025.100290
J.T. Harvey , T.E. McAlindon , J. Baek , J. MacKay , M. Zhang , G.H. Lo , S.-H. Liu , C.B. Eaton , M.S. Harkey , J.C. Patarini , J.B. Driban

INTRODUCTION

Meniscal degeneration predisposes knees without radiographic OA to develop a future meniscal tear and an accelerated onset and progression of OA. Understanding the relationship between meniscal degeneration and OA-related biomarkers in knees without radiographic OA is essential for improving early detection, monitoring disease progression, and developing intervention strategies to prevent or slow the progression of this debilitating condition.

OBJECTIVE

To explore the relationship between meniscal degeneration (intrameniscal signal alteration without a tear) and future OA pathology measured by composite scores based on MRI: disease activity (BM lesion and effusion-synovitis volumes) and cumulative damage (articular cartilage damage).

METHODS

Our sample included 225 participants from the OAI with intact menisci (defined as normal or meniscal degeneration without tear) on MRI and no radiographic knee OA at baseline. There were 110 participants with normal menisci (77% Female, 55 [SD 7] average years of age) and 115 with meniscal degeneration (60% Female, 61 [SD 9] average years of age). We used longitudinal MRIs from an existing study to calculate disease activity and cumulative damage. Negative values represent milder disease activity or cumulative damage than the average of a reference sample, among whom 93% had moderate-severe radiographic knee osteoarthritis (KLG = 3 or 4), and the average WOMAC knee pain score was 5.0 (SD=3.6). MR images were collected at each OAI site using Siemens 3.0 Tesla Trio MR systems and knee coils. Acquisitions included a sagittal IM fat-suppressed sequence (field of view=160mm, slice thickness=3mm, skip=0mm, flip angle=180 degrees, echo time=30ms, recovery time=3200ms, 313 × 448 matrix, x-resolution=0.357mm, y-resolution=0.357mm), which was used to measure BML and effusion-synovitis volumes. Cartilage damage was quantified using a 3D DESS sequence: field of view=140mm, slice thickness=0.7mm, skip=0mm, flip angle=25 degrees, echo time=4.7ms, recovery time=16.3ms, 307 × 384 matrix, x-resolution=0.365mm, y-resolution=0.365mm. We used robust regression models with M estimation and Huber weights to assess the association between baseline meniscal degeneration (exposure) and disease activity or cumulative damage at baseline and four annual follow-up visits (outcomes), adjusting for gender, race, age, static alignment, and body mass index.

RESULTS

Knees with meniscal degeneration were more likely to have, on average, 0.21 greater disease activity at 12 months than knees with normal menisci (parameter estimate=0.21, 95% confidence interval [CI]=0.09, 0.33); this association persisted over time. The association between meniscal degeneration and cumulative damage only became statistically significant at the 48-month visit (parameter estimate=0.74, 95% CI=0.18, 1.31).

CONCLUSION

This
半月板退行性变易使没有骨性关节炎的膝关节在未来发生半月板撕裂，加速骨性关节炎的发病和进展。了解半月板退变与膝关节炎相关生物标志物之间的关系对于改善早期发现、监测疾病进展以及制定干预策略以预防或减缓这种衰弱性疾病的进展至关重要。目的探讨半月板退变（无撕裂的半月板内信号改变）与未来OA病理之间的关系，通过基于MRI的综合评分来衡量：疾病活动性（BM病变和积液-滑膜炎体积）和累积损伤（关节软骨损伤）。我们的样本包括225名来自OAI的参与者，他们的半月板在MRI上是完整的（定义为正常或半月板变性无撕裂），基线时没有膝关节炎的影像学检查。110例半月板正常（77%为女性，平均年龄55岁[SD 7]）， 115例半月板变性（60%为女性，平均年龄61岁[SD 9]）。我们使用一项现有研究的纵向核磁共振成像来计算疾病活动性和累积损伤。阴性值表示疾病活动性或累积损伤较参考样本平均值轻，其中93%为中重度放射学膝关节骨关节炎（KLG = 3或4），WOMAC膝关节疼痛平均评分为5.0 （SD=3.6）。采用Siemens 3.0 Tesla Trio MR系统和膝关节线圈采集各OAI部位的MR图像。采集包括矢状面IM脂肪抑制序列（视场=160mm，切片厚度=3mm，跳跃=0mm，翻转角度=180度，回波时间=30ms，恢复时间=3200ms， 313 × 448矩阵，x分辨率=0.357mm， y分辨率=0.357mm），用于测量BML和积液-滑膜炎体积。软骨损伤采用三维DESS序列量化：视场=140mm，切片厚度=0.7mm，跳跃=0mm，翻转角度=25度，回波时间=4.7ms，恢复时间=16.3ms， 307 × 384矩阵，x分辨率=0.365mm， y分辨率=0.365mm。我们使用具有M估计和Huber权重的稳健回归模型来评估基线半月板变性（暴露）与基线和四次年度随访（结果）时疾病活动或累积损伤之间的关系，并调整性别、种族、年龄、静态排列和体重指数。结果：半月板退变患者12个月时的疾病活动度比半月板正常患者平均高0.21（参数估计=0.21,95%可信区间[CI]=0.09, 0.33）；这种联系随着时间的推移而持续。半月板退变与累积损伤之间的关联仅在48个月随访时才具有统计学意义（参数估计=0.74,95% CI=0.18, 1.31）。结论：本研究阐明了半月板退变在OA早期的关键作用，表明其与疾病活动性增加和随后的软骨损伤有关。使用基于mri的综合评分为跟踪疾病进展提供了一个强大的工具，为早期干预策略提供了有价值的见解。通过确定半月板变性是骨关节炎的前兆，我们可以更好地针对预防措施和治疗方法，最终旨在减轻这种衰弱性疾病对患者生活的影响。
{"title":"FROM MENISCAL DEGENERATION TO OSTEOARTHRITIS: TRACKING EARLY DISEASE PROGRESSION WITH MRI-BASED COMPOSITE SCORES: DATA FROM THE OSTEOARTHRITIS INITIATIVE","authors":"J.T. Harvey ,&nbsp;T.E. McAlindon ,&nbsp;J. Baek ,&nbsp;J. MacKay ,&nbsp;M. Zhang ,&nbsp;G.H. Lo ,&nbsp;S.-H. Liu ,&nbsp;C.B. Eaton ,&nbsp;M.S. Harkey ,&nbsp;J.C. Patarini ,&nbsp;J.B. Driban","doi":"10.1016/j.ostima.2025.100290","DOIUrl":"10.1016/j.ostima.2025.100290","url":null,"abstract":"<div><h3>INTRODUCTION</h3><div>Meniscal degeneration predisposes knees without radiographic OA to develop a future meniscal tear and an accelerated onset and progression of OA. Understanding the relationship between meniscal degeneration and OA-related biomarkers in knees without radiographic OA is essential for improving early detection, monitoring disease progression, and developing intervention strategies to prevent or slow the progression of this debilitating condition.</div></div><div><h3>OBJECTIVE</h3><div>To explore the relationship between meniscal degeneration (intrameniscal signal alteration without a tear) and future OA pathology measured by composite scores based on MRI: disease activity (BM lesion and effusion-synovitis volumes) and cumulative damage (articular cartilage damage).</div></div><div><h3>METHODS</h3><div>Our sample included 225 participants from the OAI with intact menisci (defined as normal or meniscal degeneration without tear) on MRI and no radiographic knee OA at baseline. There were 110 participants with normal menisci (77% Female, 55 [SD 7] average years of age) and 115 with meniscal degeneration (60% Female, 61 [SD 9] average years of age). We used longitudinal MRIs from an existing study to calculate disease activity and cumulative damage. Negative values represent milder disease activity or cumulative damage than the average of a reference sample, among whom 93% had moderate-severe radiographic knee osteoarthritis (KLG = 3 or 4), and the average WOMAC knee pain score was 5.0 (SD=3.6). MR images were collected at each OAI site using Siemens 3.0 Tesla Trio MR systems and knee coils. Acquisitions included a sagittal IM fat-suppressed sequence (field of view=160mm, slice thickness=3mm, skip=0mm, flip angle=180 degrees, echo time=30ms, recovery time=3200ms, 313 × 448 matrix, x-resolution=0.357mm, y-resolution=0.357mm), which was used to measure BML and effusion-synovitis volumes. Cartilage damage was quantified using a 3D DESS sequence: field of view=140mm, slice thickness=0.7mm, skip=0mm, flip angle=25 degrees, echo time=4.7ms, recovery time=16.3ms, 307 × 384 matrix, x-resolution=0.365mm, y-resolution=0.365mm. We used robust regression models with M estimation and Huber weights to assess the association between baseline meniscal degeneration (exposure) and disease activity or cumulative damage at baseline and four annual follow-up visits (outcomes), adjusting for gender, race, age, static alignment, and body mass index.</div></div><div><h3>RESULTS</h3><div>Knees with meniscal degeneration were more likely to have, on average, 0.21 greater disease activity at 12 months than knees with normal menisci (parameter estimate=0.21, 95% confidence interval [CI]=0.09, 0.33); this association persisted over time. The association between meniscal degeneration and cumulative damage only became statistically significant at the 48-month visit (parameter estimate=0.74, 95% CI=0.18, 1.31).</div></div><div><h3>CONCLUSION</h3><div>This","PeriodicalId":74378,"journal":{"name":"Osteoarthritis imaging","volume":"5 ","pages":"Article 100290"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144522430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
CAN REGISTRATION-BASED LOCATION-INDEPENDENT MEASUREMENT INCREASE THE SENSITIVITY TO BETWEEN-GROUP DIFFERENCES IN LONGITUDINAL CHANGE OF LAMINAR CARTILAGE T2? 基于注册的不依赖于位置的测量能否增加对组间板层软骨t2纵向变化差异的敏感性？
Osteoarthritis imaging
Pub Date : 2025-01-01 DOI: 10.1016/j.ostima.2025.100331
W. Wirth , F. Eckstein

INTRODUCTION

Location-independent measurements of cartilage thinning and thickening were shown to be more sensitive to differences in longitudinal change between groups than location-based measures [1,2]. They remove the link between the magnitude and direction of the change and its location, and hence are sensitive to local changes in the joint, independent of where they occur. Location-independent measures of T2 lengthening and shortening computed from 16 femorotibial subregions have been previously applied to a model of early OA. The model compared 3y T2 change in KLG 0 knees with contralateral (CL) joint space narrowing (JSN) vs that in KLG 0 knees with CL KLG 0 (controls) [3]. In this model, location-independent measures were found to provide similar discrimination between these two groups as location-based measures. However, location-independent measures obtained across all individual voxels in the joint (instead of subregions) have been previously suggested to provide more detailed insights into OA-related cartilage thickness changes [4], but no study previously evaluated the sensitivity of such voxel-based shortening and lengthening scores to differences in change of laminar T2.

OBJECTIVE

To compare the sensitivity of voxel-based location-independent lengthening and shortening T2 scores to between-group differences in longitudinal change vs. the previously established technique of subregion-based location-independent and location-based measures in the above early OA model.

METHODS

Multi-echo spin-echo (MESE) MRIs were acquired at year 1 and 4 in the OAI (3T Trio, Siemens). We studied 39 KLG 0 knees with CL JSN, and 39 matched controls (criteria: same sex pain frequency, similar age (±5y) and BMI (±5kg/m2)) with bilateral KLG 0 [2]. Segmentation of the 4 femorotibial cartilages (medial/lateral tibia: MT/LT and central medial/lateral femoral condyle: cMF/cLF) was performed manually by experienced readers. Laminar T2 was computed for each segmented cartilage voxel and classified as deep or superficial, based on the distance to the cartilage surfaces. Location-based and subregion-based location-independent measures were obtained as described previously [2]. Voxel-based location-independent changes in laminar T2 were derived, summarizing the negative/positive changes across all voxels, for each of the femorotibial cartilages using the voxel-based approach (Fig. 1) These were then summarized across the entire femorotibial joint (FTJ). Location-based, subregion-based location independent, and voxel-based location-independent laminar T2 change was compared between the CL JSN vs. control knees using Cohen's D as a measure of effect size with 95% confidence intervals obtained using boot-strapping.

RESULTS

In the deep layer, location-based longitudinal change in femorotibial T2 revealed a Cohen’s D between both groups of 0.37 [0.04, 0.
研究表明，与基于位置的测量相比，与位置无关的软骨变薄和增厚测量对组间纵向变化的差异更为敏感[1,2]。它们消除了变化的幅度和方向与其位置之间的联系，因此对关节的局部变化很敏感，而与它们发生的位置无关。从16个股胫亚区计算T2延长和缩短的位置无关测量先前已应用于早期OA模型。该模型比较了对侧（CL）关节间隙狭窄（JSN）的klg0膝关节与对侧（CL）关节间隙狭窄（JSN）的klg0膝关节的3y T2变化。在该模型中，发现与位置无关的措施在这两组之间提供了与基于位置的措施相似的歧视。然而，在关节的所有个体体素（而不是子区域）中获得的与位置无关的测量已经被建议为oa相关的软骨厚度变化[4]提供更详细的见解，但是之前没有研究评估这种基于体素的缩短和延长评分对层间T2变化差异的敏感性。目的比较基于体素的位置无关延长和缩短T2评分与先前建立的基于子区域的位置无关和基于位置的测量技术在上述早期OA模型中对组间纵向变化差异的敏感性。方法在OAI （3T Trio, Siemens）第1年和第4年获得多回波自旋回波（MESE） mri。我们研究了39例伴有cljsn的klg0膝关节，以及39例双侧klg0[2]的匹配对照（标准：疼痛频率相同，年龄相近（±5y）和BMI（±5kg/m2））。由经验丰富的读者手动分割4个股胫软骨（胫骨内侧/外侧：MT/LT和股骨中央内侧/外侧髁：cMF/cLF）。计算每个分段软骨体素的层流T2，并根据到软骨表面的距离将其分为深层或浅层。如前所述，获得了基于位置和基于子区域的与位置无关的测量[2]。利用基于体素的方法（图1），我们得出了椎板T2中基于体素的位置无关变化，总结了每个股胫软骨所有体素的负/正变化（图1），然后总结了整个股胫关节（FTJ）的变化。基于位置、基于子区域、基于体素的位置无关层流T2变化在CL JSN和对照膝关节之间进行比较，使用Cohen's D作为效应大小的度量，95%置信区间使用引导获得。结果在深部，基于位置的股胫T2纵向变化显示两组之间的Cohen’s D值为0.37[0.04,0.69])，基于子区域的位置独立分析为0.33[0.00,0.65])，基于体素的位置独立分析为0.36[0.04,0.68])（图2）。在表层，只有基于体素的绝对变化评分对两组纵向T2变化的差异敏感（Cohen’s D: 0.34[0.02, 0.66]）。图3显示了KLG 0膝关节与对照膝关节在体素上浅层cMF和cLF T2变化的差异模式。结论基于不同位置和不依赖于不同位置的T2分析（基于亚区和体素）对深层软骨的效应大小相似。然而，新的基于体素的方法似乎对浅表软骨层T2变化的组间差异也很敏感，其中基于位置的和基于亚区域的位置无关的方法未能提供显着的区分。此外，基于体素的技术允许可视化组间变化差异的模式，可以为未来关注特定感兴趣区域的分析提供信息。
{"title":"CAN REGISTRATION-BASED LOCATION-INDEPENDENT MEASUREMENT INCREASE THE SENSITIVITY TO BETWEEN-GROUP DIFFERENCES IN LONGITUDINAL CHANGE OF LAMINAR CARTILAGE T2?","authors":"W. Wirth ,&nbsp;F. Eckstein","doi":"10.1016/j.ostima.2025.100331","DOIUrl":"10.1016/j.ostima.2025.100331","url":null,"abstract":"<div><h3>INTRODUCTION</h3><div>Location-independent measurements of cartilage thinning and thickening were shown to be more sensitive to differences in longitudinal change between groups than location-based measures [1,2]. They remove the link between the magnitude and direction of the change and its location, and hence are sensitive to local changes in the joint, independent of where they occur. Location-independent measures of T2 lengthening and shortening computed from 16 femorotibial subregions have been previously applied to a model of early OA. The model compared 3y T2 change in KLG 0 knees with contralateral (CL) joint space narrowing (JSN) vs that in KLG 0 knees with CL KLG 0 (controls) [3]. In this model, location-independent measures were found to provide similar discrimination between these two groups as location-based measures. However, location-independent measures obtained across all individual voxels in the joint (instead of subregions) have been previously suggested to provide more detailed insights into OA-related cartilage thickness changes [4], but no study previously evaluated the sensitivity of such voxel-based shortening and lengthening scores to differences in change of laminar T2.</div></div><div><h3>OBJECTIVE</h3><div>To compare the sensitivity of voxel-based location-independent lengthening and shortening T2 scores to between-group differences in longitudinal change vs. the previously established technique of subregion-based location-independent and location-based measures in the above early OA model.</div></div><div><h3>METHODS</h3><div>Multi-echo spin-echo (MESE) MRIs were acquired at year 1 and 4 in the OAI (3T Trio, Siemens). We studied 39 KLG 0 knees with CL JSN, and 39 matched controls (criteria: same sex pain frequency, similar age (±5y) and BMI (±5kg/m<sup>2</sup>)) with bilateral KLG 0 [2]. Segmentation of the 4 femorotibial cartilages (medial/lateral tibia: MT/LT and central medial/lateral femoral condyle: cMF/cLF) was performed manually by experienced readers. Laminar T2 was computed for each segmented cartilage voxel and classified as deep or superficial, based on the distance to the cartilage surfaces. Location-based and subregion-based location-independent measures were obtained as described previously [2]. Voxel-based location-independent changes in laminar T2 were derived, summarizing the negative/positive changes across all voxels, for each of the femorotibial cartilages using the voxel-based approach (Fig. 1) These were then summarized across the entire femorotibial joint (FTJ). Location-based, subregion-based location independent, and voxel-based location-independent laminar T2 change was compared between the CL JSN vs. control knees using Cohen's D as a measure of effect size with 95% confidence intervals obtained using boot-strapping.</div></div><div><h3>RESULTS</h3><div>In the deep layer, location-based longitudinal change in femorotibial T2 revealed a Cohen’s D between both groups of 0.37 [0.04, 0.","PeriodicalId":74378,"journal":{"name":"Osteoarthritis imaging","volume":"5 ","pages":"Article 100331"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144523433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
THE INFLUENCE OF WEIGHT-BEARING AND FLEXION ON 3D JOINT SPACE WIDTH IN KNEE OSTEOARTHRITIS 负重和屈曲对膝关节骨关节炎三维关节间隙宽度的影响
Osteoarthritis imaging
Pub Date : 2025-01-01 DOI: 10.1016/j.ostima.2025.100320
F.F.J. Simonis , W.M. Brink , F.F. Schröder , W.C. Verra , T.D. Turmezei , S.C. Mastbergen , M.P. Jansen

INTRODUCTION

In knee OA, radiographic JSW is used as a surrogate for MRI-measured cartilage thickness, though they often do not correlate well. Variations in positioning between radiography (weight-bearing semi-flexion) and MRI (non-weight-bearing extension) may contribute to discrepancies.

OBJECTIVE

This study aimed to evaluate differences in 3D JSW and cartilage thickness distribution between these positions in knee OA patients.

METHODS

21 symptomatic knee OA patients (KLG 2/3) were included. Exclusion criteria included prior knee surgery, MRI ineligibility, inability to stand unassisted for 15 minutes, or knee width > 15 cm (knee coil limit). A knee MRI protocol was performed using a 0.25T weight-bearing MRI system (G-scan Brio, Esaote). A coronal 3D dual-echo SSFP sequence (SHARC) was acquired to obtain images with an isotropic resolution of 0.66mm in both extended and flexed knee positions under weight-bearing conditions by rotating the system to 81°. Both scans were repeated under non-weight-bearing conditions by rotating the system to a horizontal position (0°). Knee flexion angles were measured, and the femur and tibia bones were segmented in 3D Slicer. 3D models were exported to Stradview to measure the tibia-femur distance at each vertex as a measure of JSW. The models and data were registered to canonical surfaces in wxRegSurf and further analyzed in MATLAB using the Surfstat package for statistical parametric mapping to derive p-values corrected for multiple vertex-wise comparisons.

RESULTS

The average knee angles of the 21 patients were 7.4±3.7° (extended) and 19.1±5.5° (flexed). The average JSW ranged from 3.1 mm to 14.7 mm across patients (Figure 1). A significantly smaller JSW for weight-bearing vs non-weight-bearing conditions, particularly in the outer medial and posterior lateral tibia for extended positions, and in the posterior medial tibia for flexed positions, was seen (Figure 2). Flexion increased the JSW in the anterior tibia and decreased it in the posterior tibia, particularly laterally in weight-bearing positions.

CONCLUSION

JSW distribution in knee OA patients varies significantly depending on both weight-bearing and knee flexion angle, and radiographic JSW measurements may not accurately reflect the joint space in non-weight-bearing positions, such as those used in MRI, especially in the lateral compartment. Currently ongoing cartilage analyses will indicate to which extent these JSW variations are attributable to changes in cartilage thickness or meniscal positioning.
在膝关节骨性关节炎中，x线摄影JSW被用作mri测量的软骨厚度的替代指标，尽管它们通常不太相关。x线摄影（负重半屈曲）和MRI（非负重伸展）之间的定位差异可能导致差异。目的本研究旨在评价膝关节OA患者不同体位间关节关节的三维关节间隙和软骨厚度分布的差异。方法选取21例有症状的膝关节炎患者（KLG 2/3）。排除标准包括既往膝关节手术，MRI不合格，无法独立站立15分钟，或膝关节宽度>；15厘米（膝盖线圈限制）。膝关节MRI方案采用0.25T负重MRI系统（G-scan Brio, Esaote）。通过将系统旋转81°，获取冠状面三维双回波SSFP序列（SHARC），获得负重条件下伸直和屈曲膝关节位置各向同性分辨率为0.66mm的图像。通过将系统旋转到水平位置（0°），在非承重条件下重复两次扫描。测量膝关节屈曲角度，在3D Slicer中对股骨和胫骨进行分割，将三维模型导出到Stradview中，测量各顶点处胫骨-股骨距离，作为JSW的度量。将模型和数据在wxRegSurf中注册到规范曲面上，并在MATLAB中使用Surfstat包进行统计参数映射分析，以获得针对多个顶点比较的校正p值。结果21例患者膝关节平均角度为7.4±3.7°（伸直）和19.1±5.5°（屈曲）。患者的平均JSW范围为3.1 mm至14.7 mm（图1）。在负重和非负重条件下，JSW明显较小，特别是在伸展体位时胫骨外侧外侧和后外侧，以及屈曲体位时胫骨内侧后部（图2）。屈曲增加胫骨前部的JSW，减少胫骨后部的JSW，尤其是在负重体位时。结论膝关节骨性关节炎患者的JSW分布随负重和膝关节屈曲角度的不同而有显著差异，影像学测量的JSW可能不能准确反映非负重体位的关节间隙，如MRI中使用的关节间隙，特别是在侧室。目前正在进行的软骨分析将表明这些JSW的变化在多大程度上归因于软骨厚度或半月板位置的变化。
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引用次数: 0
BASELINE C-SCORE ON WEIGHT-BEARING CT PREDICTS 2-YEAR WORSENING OF KNEE PAIN IN WOMEN 负重ct基线c评分预测2年女性膝关节疼痛恶化
Osteoarthritis imaging
Pub Date : 2025-01-01 DOI: 10.1016/j.ostima.2025.100345
S. Li , N.A. Segal , I. Tolstykh , M.C. Nevitt , T.D. Turmezei

INTRODUCTION

The B-score is a statistical score derived from non-weight-bearing MRI to assess femoral bone shape and its relationship with knee OA. However, CT scans may offer a more reliable and robust evaluations of bone shape, as they not only provide clearer differentiation between bone and soft tissue but also eliminate distortion artefact that can occur with MRI.

OBJECTIVE

To investigate a new “C-score” for femoral bone shape derived from CT as a predictive imaging biomarker for worsening knee pain in men and women with or at risk for knee osteoarthritis.

METHODS

This study included 649 knees from 389 participants (219 women) with a mean±SD age of 63.8±9.6 years and BMI of 28.5±5.0 kg/m². C-scores were calculated from baseline weight-bearing CT (WBCT) imaging of the knee joint: 0.37 mm voxels, FOV 30 × 20 cm, 120 kVp, 5.0 mA on a LineUp scanner, Curvebeam LLC, Warrington, PA. All distal femurs were segmented using Stradview to produce a surface mesh. A canonical distal femur mesh was registered using wxRegSurf to each individual femur to build the study population shape model. Each knee's C-score was derived from the distance along the vector for femur shape between the average KL0/1 and KL2/3/4 shapes from the study population using a custom script in MATLAB. A single unit of the C-score was standardized as 1SD along this vector for the KL0/1 population (Figure 1). Generalized estimating equations adjusted for age, sex, BMI and presence of up to 2 knees per participant were used to assess associations between baseline C-score and 2-year minimally clinically important worsening (MCIW) of the Western Ontario McMaster’s University Osteoarthritis Scale (WOMAC) pain subscore (2 points). MCIW is defined as the smallest difference on a pain scale that either patients perceive as worsening or requires change in treatment.

RESULTS

186 knees demonstrated pain worsening (32.71% women and 23.2% men). 98 knees had MCIW of pain (19.0% women and 9.8% men). C-scores ranged from -2.64 to +3.34 in women and -3.96 to +2.83 in men, with mean±SD values of 0.16±1.06 and -0.52±1.01 respectively (p-value for difference between sexes p=0.0003). Women without MCIW pain had a mean C-score of +0.31, while those with worsening pain had a mean C-score of +0.72. Men had mean C-scores of -0.03 and -0.01, respectively. In fully adjusted models, baseline C-score predicted 2-year MCIW pain (OR: 1.27, 95% CI: 1.00–1.62, p=0.047). In sex-stratified models, the odds ratios for 2-year MCIW pain in women and men were 1.49 (95% CI: 1.10–2.01, p=0.0159) and 1.01 (95% CI: 0.70–1.47, p=0.95), respectively.

CONCLUSION

Higher C-scores in women were significantly associated with worsening knee pain over 2 years, suggesting the C-score as a potential predictive biomarker for knee pain progression.
b评分是通过非负重MRI评估股骨形状及其与膝关节OA的关系得出的统计评分。然而，CT扫描可以提供更可靠、更有力的骨形状评估，因为它们不仅可以更清晰地区分骨骼和软组织，还可以消除MRI可能出现的畸变伪影。目的：研究一种新的CT股骨骨形状“c评分”作为预测患有或有患膝骨关节炎风险的男性和女性膝关节疼痛恶化的成像生物标志物。方法本研究包括389名参与者（219名女性）的649个膝关节，平均±SD年龄为63.8±9.6岁，BMI为28.5±5.0 kg/m²。根据膝关节的基线负重CT （WBCT）成像计算c评分：0.37 mm体素，FOV 30 × 20 cm, 120 kVp, 5.0 mA（在美国宾夕法尼亚州沃灵顿的Curvebeam LLC的一台line扫描仪上）。使用Stradview对所有远端股骨进行分割以产生表面网格。使用wxRegSurf对每个个体股骨注册一个规范的远端股骨网格，以建立研究群体形状模型。使用MATLAB中的自定义脚本，从研究人群的平均KL0/1和KL2/3/4形状之间沿股骨形状矢量的距离得出每个膝关节的c评分。对于KL0/1人群，c评分的单个单位被标准化为1SD（图1）。根据年龄、性别、BMI和每位参与者最多2个膝关节调整的广义估计方程，用于评估基线c评分与西安大略省麦克马斯特大学骨关节炎量表（WOMAC）疼痛亚评分（2分）的2年最低临床重要恶化（MCIW）之间的关系。MCIW被定义为疼痛量表上的最小差异，患者认为其恶化或需要改变治疗。结果186例患者膝关节疼痛加重，其中女性32.71%，男性23.2%。98个膝关节有mcw疼痛（女性19.0%，男性9.8%）。c -评分女性为-2.64 ~ +3.34，男性为-3.96 ~ +2.83，平均±SD值分别为0.16±1.06和-0.52±1.01（两性差异p值p=0.0003）。无MCIW疼痛的妇女的平均c -评分为+0.31，而疼痛加重的妇女的平均c -评分为+0.72。男性的平均c -得分分别为-0.03和-0.01。在完全调整的模型中，基线c评分预测2年MCIW疼痛（OR: 1.27, 95% CI: 1.00-1.62, p=0.047）。在性别分层模型中，女性和男性2年MCIW疼痛的优势比分别为1.49 （95% CI: 1.10-2.01, p=0.0159）和1.01 （95% CI: 0.70-1.47, p=0.95）。结论：女性较高的c -评分与2年内膝关节疼痛恶化显著相关，提示c -评分可作为膝关节疼痛进展的潜在预测性生物标志物。
{"title":"BASELINE C-SCORE ON WEIGHT-BEARING CT PREDICTS 2-YEAR WORSENING OF KNEE PAIN IN WOMEN","authors":"S. Li ,&nbsp;N.A. Segal ,&nbsp;I. Tolstykh ,&nbsp;M.C. Nevitt ,&nbsp;T.D. Turmezei","doi":"10.1016/j.ostima.2025.100345","DOIUrl":"10.1016/j.ostima.2025.100345","url":null,"abstract":"<div><h3>INTRODUCTION</h3><div>The B-score is a statistical score derived from non-weight-bearing MRI to assess femoral bone shape and its relationship with knee OA. However, CT scans may offer a more reliable and robust evaluations of bone shape, as they not only provide clearer differentiation between bone and soft tissue but also eliminate distortion artefact that can occur with MRI.</div></div><div><h3>OBJECTIVE</h3><div>To investigate a new “C-score” for femoral bone shape derived from CT as a predictive imaging biomarker for worsening knee pain in men and women with or at risk for knee osteoarthritis.</div></div><div><h3>METHODS</h3><div>This study included 649 knees from 389 participants (219 women) with a mean±SD age of 63.8±9.6 years and BMI of 28.5±5.0 kg/m². C-scores were calculated from baseline weight-bearing CT (WBCT) imaging of the knee joint: 0.37 mm voxels, FOV 30 × 20 cm, 120 kVp, 5.0 mA on a LineUp scanner, Curvebeam LLC, Warrington, PA. All distal femurs were segmented using Stradview to produce a surface mesh. A canonical distal femur mesh was registered using wxRegSurf to each individual femur to build the study population shape model. Each knee's C-score was derived from the distance along the vector for femur shape between the average KL0/1 and KL2/3/4 shapes from the study population using a custom script in MATLAB. A single unit of the C-score was standardized as 1SD along this vector for the KL0/1 population (Figure 1). Generalized estimating equations adjusted for age, sex, BMI and presence of up to 2 knees per participant were used to assess associations between baseline C-score and 2-year minimally clinically important worsening (MCIW) of the Western Ontario McMaster’s University Osteoarthritis Scale (WOMAC) pain subscore (2 points). MCIW is defined as the smallest difference on a pain scale that either patients perceive as worsening or requires change in treatment.</div></div><div><h3>RESULTS</h3><div>186 knees demonstrated pain worsening (32.71% women and 23.2% men). 98 knees had MCIW of pain (19.0% women and 9.8% men). C-scores ranged from -2.64 to +3.34 in women and -3.96 to +2.83 in men, with mean±SD values of 0.16±1.06 and -0.52±1.01 respectively (p-value for difference between sexes p=0.0003). Women without MCIW pain had a mean C-score of +0.31, while those with worsening pain had a mean C-score of +0.72. Men had mean C-scores of -0.03 and -0.01, respectively. In fully adjusted models, baseline C-score predicted 2-year MCIW pain (OR: 1.27, 95% CI: 1.00–1.62, p=0.047). In sex-stratified models, the odds ratios for 2-year MCIW pain in women and men were 1.49 (95% CI: 1.10–2.01, p=0.0159) and 1.01 (95% CI: 0.70–1.47, p=0.95), respectively.</div></div><div><h3>CONCLUSION</h3><div>Higher C-scores in women were significantly associated with worsening knee pain over 2 years, suggesting the C-score as a potential predictive biomarker for knee pain progression.</div></div>","PeriodicalId":74378,"journal":{"name":"Osteoarthritis imaging","volume":"5 ","pages":"Article 100345"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144523606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
QUANTIFYING JOINT GEOMETRY IN HUMAN HANDS FROM IMAGING DATA 从成像数据量化人手关节几何
Osteoarthritis imaging
Pub Date : 2025-01-01 DOI: 10.1016/j.ostima.2025.100281
C.B. Burson-Thomas

INTRODUCTION

The geometry of the same joint varies substantially between people. Typical variation in merely how conforming the two subchondral bone surfaces are can increase the peak compressive stress on the articular cartilage by as much as the additional loading from becoming obese will. The mechanical environment of joint tissues is considered to play a central role in OA development. Quantifying joint geometry using repeatable, reliable, and accessible metrics supports better understanding of the relative importance (or unimportance) of this source of variability between people on their individual OA risk and this factor’s role at a population level.

OBJECTIVE

Previous methods of quantifying joint congruence (a measure of how conforming two surfaces are) have required detailed mathematical descriptions of the articulating surfaces and their relative position. We have developed a new method of measuring joint congruence that works directly from the 3D segmented point clouds. This has been applied to a joint in the thumb.

METHODS

The first step of the new methodology involves performing a Finite Element (FE) simulation of an elastic layer compressed between each set of segmented bones (Figure 1). The results of this are then interpreted using the elastic foundation model (Figure 2), enabling an equivalent, but far simpler, contact geometry to be identified. This far simpler equivalent geometry takes the form of a sphere contacting a flat surface. The identified congruence metric is the radius of this sphere, the ‘equivalent radius’, which produces an equivalent contact to that identified in each FE simulation. The minimal JSW (in this joint position) can also be estimated from the FE simulations. The new method has been applied to a small sample (n = 10) of healthy instances (5M:5F, mean age 31yrs) of the thumb metacarpophalangeal (MCP) joint (IRAS Ethics Ref: 14/LO/1059). Each participant’s right hand was CT scanned with near-isotropic voxel size (0.293 × 0.293 × 0.312 mm) and the bones segmented using a greyscale threshold.

RESULTS

To enable an appropriate reduction of the complex geometry represented in the 3D points clouds to one number (the radius of an equivalent ‘ball on flat’), this single parameter must continue to capture the joint’s geometry as the contact area increases. For all thumb MCP geometries tested, the force-displacement response of the elastic layer could be well-described by an identified equivalent radius, unique to that particular joint (Figure 3). The thumb MCPs had a mean equivalent radius of 17.9 mm (SD = 10.6 mm) and mean minimal JSW of 0.86 mm (SD = 0.24 mm). No relationship between congruence and joint space width was observed (Figure 4).

CONCLUSION

The new method can perform an efficient quantification of congruence, reducing two 3D point clouds to a single parameter. However, fu
同一关节的几何形状在不同的人之间差别很大。仅仅是两个软骨下骨表面的一致性的典型变化，就可以增加关节软骨的峰值压缩应力，其增量与肥胖带来的额外负荷相当。关节组织的机械环境被认为在OA的发展中起着核心作用。使用可重复的、可靠的、可访问的度量来量化关节的几何形状，有助于更好地理解个体OA风险中这一变异性来源的相对重要性（或不重要性），以及这一因素在人群水平上的作用。目的以前量化关节同余度的方法（衡量两个表面的一致性）需要对关节表面及其相对位置进行详细的数学描述。我们开发了一种新的方法来测量关节同余，直接从三维分割点云。这已经应用到拇指的一个关节上。新方法的第一步涉及对每组分段骨之间压缩的弹性层进行有限元（FE）模拟（图1）。然后使用弹性基础模型（图2）对其结果进行解释，从而可以识别出等效但更简单的接触几何形状。这个简单得多的等效几何是一个球体接触一个平面的形式。确定的同余度度量是这个球体的半径，即“等效半径”，它产生与每个有限元模拟中确定的等效接触。最小JSW（在这个关节位置）也可以从有限元模拟中估计出来。新方法已应用于拇指掌指关节（MCP）健康实例（5M:5F，平均年龄31岁）的小样本（n = 10）（IRAS Ethics Ref: 14/LO/1059）。对每位参与者的右手进行近各向同性体素大小（0.293 × 0.293 × 0.312 mm）的CT扫描，并使用灰度阈值对骨骼进行分割。为了能够将3D点云中表示的复杂几何形状适当地减少到一个数字（等效的“平面上的球”的半径），随着接触面积的增加，这个参数必须继续捕获关节的几何形状。对于所有测试的拇指MCP几何形状，弹性层的力-位移响应可以通过确定的等效半径来很好地描述，这是特定关节所特有的（图3）。拇指MCPs的平均等效半径为17.9 mm (SD = 10.6 mm)，平均最小JSW为0.86 mm （SD = 0.24 mm）。余度与关节间隙宽度之间没有关系（图4）。结论该方法可以有效地对同余性进行量化，将两个三维点云简化为单个参数。然而，该方法的进一步应用一直被推迟，直到有关CT/MRI扫描分辨率的作用和关节软骨空间变化几何形状的问题得到更详细的探讨。使用手的μCT数据集检查这些问题的初步结果可以共享（图5和6）。
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引用次数: 0
EVALUATION OF DIFFERENT METHODS OF AUTOMATED 3-D JOINT SPACE MAPPING FROM WEIGHT BEARING CT SUGGESTS A TIBIAL MESH-TO-MESH APPROACH IS MOST SENSITIVE 对负重ct自动三维关节空间映射的不同方法的评估表明，胫骨网格到网格的方法是最敏感的
Osteoarthritis imaging
Pub Date : 2025-01-01 DOI: 10.1016/j.ostima.2025.100338
N.A. Segal , T. Whitmarsh , N.H. Degala , J.A. Lynch , T.D. Turmezei

INTRODUCTION

Weight bearing CT (WBCT) has the distinct advantage over radiography of being able to provide 3-D imaging of the knee joint while standing. It is also more practicable and better at depicting mineralized joint structures than MRI. Several different approaches to 3-D JSW measurement have been developed, but their repeatability has not been directly compared.

OBJECTIVE

To compare the test-retest repeatability of three different methods of 3-D joint space mapping (JSM) of the tibiofemoral compartment from WBCT imaging data.

METHODS

14 individuals recruited and consented at the University of Kansas Medical Center had baseline and follow-up WBCT imaging suitable for analysis. Participant demographics were: mean ± SD age 61.3 ± 8.4 years, BMI 30.7 ± 4.3 kg/m2 and male:female ratio 8:6. All scanning was performed on the same XFI WBCT scanner (Planmed Oy, Helsinki, Finland) with the mean ± SD interval between baseline and follow-up attendances 14.9 ± 8.1 days. A SynaflexerTM device was used to standardize knee positioning during scanning. Imaging acquisition parameters were 96 kV tube voltage, 51.4 mA tube current, 3.5 s exposure time. A standard bone algorithm was applied for reconstruction with 0.3 mm isotropic voxels and a 21 cm vertical scan range. Both knees were included in all analyses with SD adjustments made for multiple observations from the same individual. Participant ID and scan sequence were anonymized prior to analyses. An algorithm based on U-net was implemented in C++ using LibTorch and integrated into ScanXM software for automatic segmentation of the femur and tibia from all knees. Three different JSM techniques were applied: (1) femur-to-tibia deconvolution in which the femur was the base (performed in Stradview); (2) tibia-to-femur deconvolution in which the same was done but from the tibia; and (3) tibia-to-femur mesh-to-mesh distance using a custom MATLAB script. Results from each technique were registered using wxRegSurf and displayed on their average halfway joint space mesh (i.e. the middle plane of the joint space) using custom MATLAB scripts. Bland Altman descriptive statistics were calculated as 3-D bias (follow-up minus baseline) and limit of agreement (LOA) maps for all knees. Summary statistics also included root mean square coefficient of variation (RMSCV) and LOA as a % of the mean.

RESULTS

3-D bias and LOA maps for all knees are displayed on the halfway joint space patches as if viewing the right knee from the inferior aspect (Figure 1). Both deconvolution techniques showed similar noise patterns of bias around a zero value, while the mesh-to-mesh technique suggested systematically wider anterior and narrower posterior JSW at follow-up, but this was of sub-millimeter magnitude. Both deconvolution techniques also showed a pattern of worsening LOA towards the joint space patch margins,
负重CT （WBCT）与x线摄影相比具有明显的优势，能够在站立时提供膝关节的三维成像。它在描绘矿化关节结构方面也比MRI更实用、更好。已经开发了几种不同的3-D JSW测量方法，但是它们的可重复性没有直接比较。目的比较三种不同方法对胫股间室三维关节空间定位（JSM）的重复性。方法在堪萨斯大学医学中心招募并同意的14名患者进行了适合分析的基线和随访WBCT成像。参与者的人口统计数据为：平均±SD年龄61.3±8.4岁，BMI 30.7±4.3 kg/m2，男女比例8:6。所有扫描均在同一台XFI WBCT扫描仪上进行（Planmed y, Helsinki, Finland），基线和随访的平均±SD间隔为14.9±8.1天。扫描时使用SynaflexerTM设备对膝关节定位进行标准化。成像采集参数为96 kV管电压，51.4 mA管电流，3.5 s曝光时间。采用标准骨算法重建，各向同性体素为0.3 mm，垂直扫描范围为21 cm。所有分析均包括双膝，并对同一个体的多次观察进行标准差调整。在分析之前，参与者ID和扫描序列被匿名化。利用LibTorch在c++语言中实现了一种基于U-net的算法，并将其集成到ScanXM软件中，实现了全膝关节股骨和胫骨的自动分割。应用三种不同的JSM技术：(1)以股骨为基底的股骨-胫骨反褶积（在Stradview中进行）；(2)胫骨-股骨反褶积，从胫骨进行相同的反褶积；(3)胫骨到股骨的网格间距离（使用自定义MATLAB脚本）。使用wxRegSurf对每种技术的结果进行注册，并使用自定义MATLAB脚本在其平均半关节空间网格（即关节空间的中间平面）上显示。Bland Altman描述性统计计算为所有膝关节的3-D偏倚（随访减去基线）和一致限（LOA）图。汇总统计还包括均方根变异系数（RMSCV）和LOA占平均值的百分比。结果所有膝关节的三维偏置图和LOA图显示在关节间隙中间贴片上，就像从下侧面观察右膝关节一样（图1）。两种反卷积技术在零值附近显示出相似的偏置噪声模式，而mesh-to-mesh技术在随访时显示出系统性的前侧偏宽和后侧偏窄，但这是亚毫米量级的。两种反褶积技术也显示出LOA向联合空间斑块边缘恶化的模式，这被认为是数据平滑可能夸大错误或null值的地方。Mesh-to-mesh LOA在整个关节空间中更加稳健。在比较KLG和lt的重复性测量时；2和KLG = 2组（表1），所有技术在整个关节空间的LOA相似，各组之间的LOA值为1.29至1.46 mm，而在两个腔室的内侧，mesh-to-mesh KLG = 2组的最佳LOA值为0.13 mm。结论：尽管三种JSM入路之间的差异很小，但基于胫骨的mesh-to-mesh技术可能更稳健，特别是在关节间隙边缘。在KLG患者中，由于LOA最低（因此可检测到的差异最小），该方法在检测JSW的较小变化方面似乎也具有更高的潜在敏感性 = 2，这是OA临床试验中在结构性疾病过于严重之前的重要分层。然而，从分割中衍生出的JSM的网格对网格方法的警告是，它依赖于分割技术的准确性，这可能在不同的方法之间有所不同，而反卷积方法已被证明是准确的，只是可重复性较低。
{"title":"EVALUATION OF DIFFERENT METHODS OF AUTOMATED 3-D JOINT SPACE MAPPING FROM WEIGHT BEARING CT SUGGESTS A TIBIAL MESH-TO-MESH APPROACH IS MOST SENSITIVE","authors":"N.A. Segal ,&nbsp;T. Whitmarsh ,&nbsp;N.H. Degala ,&nbsp;J.A. Lynch ,&nbsp;T.D. Turmezei","doi":"10.1016/j.ostima.2025.100338","DOIUrl":"10.1016/j.ostima.2025.100338","url":null,"abstract":"<div><h3>INTRODUCTION</h3><div>Weight bearing CT (WBCT) has the distinct advantage over radiography of being able to provide 3-D imaging of the knee joint while standing. It is also more practicable and better at depicting mineralized joint structures than MRI. Several different approaches to 3-D JSW measurement have been developed, but their repeatability has not been directly compared.</div></div><div><h3>OBJECTIVE</h3><div>To compare the test-retest repeatability of three different methods of 3-D joint space mapping (JSM) of the tibiofemoral compartment from WBCT imaging data.</div></div><div><h3>METHODS</h3><div>14 individuals recruited and consented at the University of Kansas Medical Center had baseline and follow-up WBCT imaging suitable for analysis. Participant demographics were: mean ± SD age 61.3 ± 8.4 years, BMI 30.7 ± 4.3 kg/m<sup>2</sup> and male:female ratio 8:6. All scanning was performed on the same XFI WBCT scanner (Planmed Oy, Helsinki, Finland) with the mean ± SD interval between baseline and follow-up attendances 14.9 ± 8.1 days. A Synaflexer<sup>TM</sup> device was used to standardize knee positioning during scanning. Imaging acquisition parameters were 96 kV tube voltage, 51.4 mA tube current, 3.5 s exposure time. A standard bone algorithm was applied for reconstruction with 0.3 mm isotropic voxels and a 21 cm vertical scan range. Both knees were included in all analyses with SD adjustments made for multiple observations from the same individual. Participant ID and scan sequence were anonymized prior to analyses. An algorithm based on U-net was implemented in C++ using LibTorch and integrated into ScanXM software for automatic segmentation of the femur and tibia from all knees. Three different JSM techniques were applied: (1) femur-to-tibia deconvolution in which the femur was the base (performed in Stradview); (2) tibia-to-femur deconvolution in which the same was done but from the tibia; and (3) tibia-to-femur mesh-to-mesh distance using a custom MATLAB script. Results from each technique were registered using wxRegSurf and displayed on their average halfway joint space mesh (i.e. the middle plane of the joint space) using custom MATLAB scripts. Bland Altman descriptive statistics were calculated as 3-D bias (follow-up minus baseline) and limit of agreement (LOA) maps for all knees. Summary statistics also included root mean square coefficient of variation (RMSCV) and LOA as a % of the mean.</div></div><div><h3>RESULTS</h3><div>3-D bias and LOA maps for all knees are displayed on the halfway joint space patches as if viewing the right knee from the inferior aspect (Figure 1). Both deconvolution techniques showed similar noise patterns of bias around a zero value, while the mesh-to-mesh technique suggested systematically wider anterior and narrower posterior JSW at follow-up, but this was of sub-millimeter magnitude. Both deconvolution techniques also showed a pattern of worsening LOA towards the joint space patch margins,","PeriodicalId":74378,"journal":{"name":"Osteoarthritis imaging","volume":"5 ","pages":"Article 100338"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144523922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
LEVI-04, A NOVEL NEUROTROPHIN-3 INHIBITOR, DEMONSTRATED SIGNIFICANT IMPROVEMENTS IN PAIN AND FUNCTION AND WAS NOT ASSOCIATED WITH DELETERIOUS EFFECTS ON JOINT STRUCTURE IN PEOPLE WITH KNEE OA IN A PHASE II RCT Levi-04是一种新型的神经营养因子-3抑制剂，在一项ii期随机对照试验中，显示出对膝关节oa患者疼痛和功能的显著改善，并且与关节结构的有害影响无关
Osteoarthritis imaging
Pub Date : 2025-01-01 DOI: 10.1016/j.ostima.2025.100352
P.G. Conaghan , A. Guermazi , N. Katz , A.R. Bihlet , D. Rom , C.M. Perkins , B. Hughes , C. Herholdt , I. Bombelka , S.L. Westbrook

INTRODUCTION

Improvement in the symptoms of osteoarthritis (OA) remains a serious unmet medical need and new pharmacological treatments are urgently needed. Excess neurotrophins (NT) are implicated in OA and other painful conditions. Previous analgesic therapies selectively targeting NGF inhibition provided improvements in pain and function, but were dose-dependently associated with significant joint pathologies, including rapidly progressive OA (RPOA). LEVI-04 is a first-in-class fusion protein (p75NTR-Fc) that supplements the endogenous p75NTR binding protein, providing analgesia via inhibition of NT-3 activity. Here we present efficacy and safety data from the phase II RCT of LEVI-04 in people with knee OA.

METHODS

This was a PhII multicentre (Europe and Hong Kong) RCT in people with painful (≥4/10 WOMAC), radiographic (KL≥2) knee OA. Participants were randomised to baseline then 4-weekly IV placebo or 0.3, 1, or 2mg/kg LEVI-04 through week16. The primary efficacy endpoint was assessed at week 17, safety assessments were assessed to week 20, with a telephone safety follow-up at week 30. The primary endpoint was change in WOMAC pain to week 17, with additional outcomes including function, Patient Global Assessment (PGA), 50 and 70% pain responders, a novel pain on movement assessment (the Staircase-evoked Pain Procedure, StEPP) and daily NRS pain scores. Safety and tolerability, including Adverse Events of Special Interest (AESI) concerning joint pathologies, were key secondary endpoints. X-rays of 6 large joints and MRI of knees were utilised for inclusion/exclusion criteria at baseline, and safety evaluation at week 20. All safety events involving joints were escalated to an independent Adjudication Committee.

RESULTS

518 people with knee OA were enrolled (mean age 63.1–65.4 years, mean BMI 29.3–30.3, female participants 51.5–61.5%). LEVI-04 demonstrated significant differences to placebo for the primary endpoint for all doses (Figure 1). WOMAC function and stiffness, PGA, daily pain scores, and StEPP were all statistically different to placebo. LEVI-04 was well tolerated, with no increased incidence of SAEs, TEAEs (Table 1) or joint pathologies, including RPOA (Table 2), compared to placebo.

CONCLUSION

LEVI-04 demonstrated significant and clinically meaningful improvement in pain, function and other efficacy outcomes. LEVI-04 was well tolerated at all doses studied, supporting the concept of supplementing endogenous p75NTR as a treatment for OA and other pain conditions. Phase III trials are in planning.
骨关节炎（OA）症状的改善仍然是一个严重的未满足的医学需求，迫切需要新的药物治疗。过量的神经营养因子（NT）与OA和其他疼痛状况有关。先前选择性靶向NGF抑制的镇痛疗法可以改善疼痛和功能，但与显著的关节病变（包括快速进行性OA (RPOA)）存在剂量依赖性。LEVI-04是一种一流的融合蛋白（p75NTR- fc），补充内源性p75NTR结合蛋白，通过抑制NT-3活性提供镇痛作用。在这里，我们提供了LEVI-04在膝关节OA患者中的II期RCT的有效性和安全性数据。方法：这是一项多中心（欧洲和香港）的PhII随机对照试验，研究对象为疼痛性（≥4/10 WOMAC）、影像学（KL≥2）膝关节OA患者。参与者被随机分配到基线组，然后4周静脉注射安慰剂或0.3、1或2mg/kg LEVI-04至第16周。在第17周评估主要疗效终点，在第20周评估安全性，在第30周进行电话安全性随访。主要终点是第17周WOMAC疼痛的变化，其他结果包括功能，患者整体评估（PGA）， 50%和70%的疼痛反应，一种新的运动疼痛评估（阶梯诱发疼痛程序，StEPP）和每日NRS疼痛评分。安全性和耐受性，包括与关节病理相关的特殊不良事件（AESI），是关键的次要终点。基线时使用6个大关节的x光片和膝关节的MRI作为纳入/排除标准，并在第20周进行安全性评估。所有涉及关节的安全事件均交由独立的评审委员会处理。结果纳入518例膝关节OA患者（平均年龄63.1 ~ 65.4岁，平均BMI 29.3 ~ 30.3，女性51.5 ~ 61.5%）。LEVI-04在所有剂量的主要终点均与安慰剂有显著差异（图1）。WOMAC功能和僵硬度、PGA、每日疼痛评分和StEPP均与安慰剂组有统计学差异。LEVI-04耐受性良好，与安慰剂相比，SAEs、teae（表1）或包括RPOA（表2）在内的关节病变发生率均未增加。结论levi -04对疼痛、功能及其他疗效指标均有显著改善，具有临床意义。LEVI-04在所有剂量的研究中都具有良好的耐受性，这支持了补充内源性p75NTR作为OA和其他疼痛疾病治疗的概念。III期试验正在计划中。
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