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Eckstein F.,Paracelsus Medical University | Eckstein F.,Chondrometrics GmbH | Guermazi A.,Boston University | Guermazi A.,Boston Imaging Core Laboratory BICL | And 6 more authors.
Osteoarthritis and Cartilage | Year: 2014

Imaging in clinical trials is used to evaluate subject eligibility, and/or efficacy of intervention, supporting decision making in drug development by ascertaining treatment effects on joint structure. This review focusses on imaging of bone and cartilage in clinical trials of (knee) osteoarthritis. We narratively review the full-text literature on imaging of bone and cartilage, adding primary experience in the implementation of imaging methods in clinical trials. Aims and constraints of applying imaging in clinical trials are outlined. The specific uses of semi-quantitative and quantitative imaging biomarkers of bone and cartilage in osteoarthritis trials are summarized, focusing on radiography and magnetic resonance imaging (MRI). Studies having compared both imaging methodologies directly and those having established a relationship between imaging biomarkers and clinical outcomes are highlighted. To make this review of practical use, recommendations are provided as to which imaging protocols are ideal for capturing specific aspects of bone and cartilage tissue, and pitfalls in their usage are highlighted. Further, the longitudinal sensitivity to change, of different imaging methods is reported for various patient strata. From these power calculations can be accomplished, provided the strength of the treatment effect is known. In conclusion, current imaging methodologies provide powerful tools for scoring and measuring morphological and compositional aspects of most articular tissues, capturing longitudinal change with reasonable to excellent sensitivity. When employed properly, imaging has tremendous potential for ascertaining treatment effects on various joint structures, potentially over shorter time scales than required for demonstrating effects on clinical outcomes. © 2014 Osteoarthritis Research Society International.


Bloecker K.,Paracelsus Medical University | Wirth W.,Paracelsus Medical University | Guermazi A.,Boston University | Guermazi A.,Boston Imaging Core Laboratory BICL | And 3 more authors.
European Radiology | Year: 2015

Objective: We aimed to apply 3D MRI-based measurement technology to studying 2-year change in quantitative measurements of meniscus size and position. Methods: Forty-seven knees from the Osteoarthritis Initiative with medial radiographic joint space narrowing had baseline and 2-year follow-up MRIs. Quantitative measures were obtained from manual segmentation of the menisci and tibia using coronal DESSwe images. The standardized response mean (SRM = mean/SD change) was used as measure of sensitivity to longitudinal change. Results: Medial tibial plateau coverage decreased from 34.8 % to 29.9 % (SRM -0.82; p < 0.001). Change in medial meniscus extrusion in a central image (SRM 0.18) and in the central five slices (SRM 0.22) did not reach significance, but change in extrusion across the entire meniscus (SRM 0.32; p = 0.03) and in the relative area of meniscus extrusion (SRM 0.56; p < 0.001) did. There was a reduction in medial meniscus volume (10 %; p < 0.001), width (7 %; p < 0.001), and height (2 %; p = 0.08); meniscus substance loss was strongest in the posterior (SRM -0.51; p = 0.001) and weakest in the anterior horn (SRM -0.15; p = 0.31). Conclusion: This pilot study reports, for the first time, longitudinal change in quantitative 3D meniscus measurements in knee osteoarthritis. It provides evidence of improved sensitivity to change of 3D measurements compared with single slice analysis. Key Points: • First longitudinal MRI-based measurements of change of meniscus position and size. • Quantitative longitudinal evaluation of meniscus change in knee osteoarthritis. • Improved sensitivity to change of 3D measurements compared with single slice analysis. © 2015, European Society of Radiology.


Bloecker K.,Paracelsus Medical University | Wirth W.,Paracelsus Medical University | Wirth W.,University of Arizona | Hunter D.J.,University of Sydney | And 8 more authors.
European Journal of Radiology | Year: 2013

Background: Radiographic joint space width (JSW) is considered the reference standard for demonstratingstructural therapeutic benefits in knee osteoarthritis. Our objective was to determine the proportion bywhich 3D (regional) meniscus and cartilage measures explain between-knee differences of JSW in thefixed flexion radiographs.Methods: Segmentation of the medial meniscus and tibial and femoral cartilage was performed in doubleecho steady state (DESS) images. Quantitative measures of meniscus size and position, femorotibial carti-lage thickness, and radiographic JSW (minimum, and fixed locations) were compared between both kneesof 60 participants of the Osteoarthritis Initiative, with strictly unilateral medial joint space narrowing(JSN). Statistical analyses (between-knee, within-person comparison) were performed using regressionanalysis.Results: A strong relationship with side-differences in minimum and a central fixed location JSW wasobserved for percent tibial plateau coverage by the meniscus (r = .59 and .47; p < .01) and central femoralcartilage thickness (r = .69 and .75; p < .01); other meniscus and cartilage measures displayed lowercoefficients. The correlation of central femoral cartilage thickness with JSW (but not that of menis-cus measures) was greater (r = .78 and .85; p < .01) when excluding knees with non-optimal alignmentbetween the tibia and X-ray beam.Conclusion: 3D measures of meniscus and cartilage provide significant, independent information inexplaining side-differences in radiographic JSW in fixed flexion radiographs. Tibial coverage by the menis-cus and central femoral cartilage explained two thirds of the variability in minimum and fixed locationJSW. JSW provides a better representation of (central) femorotibial cartilage thickness, when optimalpositioning of the fixed flexion radiographs is achieved. © 2013 Elsevier Ireland Ltd. All rights reserved.


Emmanuel K.,Paracelsus Medical University | Quinn E.,Boston University | Niu J.,Boston University | Guermazi A.,Boston University | And 9 more authors.
Osteoarthritis and Cartilage | Year: 2016

Objective: To test the hypothesis that quantitative measures of meniscus extrusion predict incident radiographic knee osteoarthritis (KOA), prior to the advent of radiographic disease. Methods: 206 knees with incident radiographic KOA (Kellgren Lawrence Grade (KLG) 0 or 1 at baseline, developing KLG 2 or greater with a definite osteophyte and joint space narrowing (JSN) grade ≥1 by year 4) were matched to 232 control knees not developing incident KOA. Manual segmentation of the central five slices of the medial and lateral meniscus was performed on coronal 3T DESS MRI and quantitative meniscus position was determined. Cases and controls were compared using conditional logistic regression adjusting for age, sex, BMI, race and clinical site. Sensitivity analyses of early (year [Y] 1/2) and late (Y3/4) incidence was performed. Results: Mean medial extrusion distance was significantly greater for incident compared to non-incident knees (1.56 mean ± 1.12 mm SD vs 1.29 ± 0.99 mm; +21%, P < 0.01), so was the percent extrusion area of the medial meniscus (25.8 ± 15.8% vs 22.0 ± 13.5%; +17%, P < 0.05). This finding was consistent for knees restricted to medial incidence. No significant differences were observed for the lateral meniscus in incident medial KOA, or for the tibial plateau coverage between incident and non-incident knees. Restricting the analysis to medial incident KOA at Y1/2 differences were attenuated, but reached significance for extrusion distance, whereas no significant differences were observed at incident KOA in Y3/4. Conclusion: Greater medial meniscus extrusion predicts incident radiographic KOA. Early onset KOA showed greater differences for meniscus position between incident and non-incident knees than late onset KOA. © 2015 Osteoarthritis Research Society International.


Crema M.D.,Boston University | Crema M.D.,Boston Imaging Core Laboratory BICL | Crema M.D.,University of Sao Paulo | Guermazi A.,Boston University | And 9 more authors.
Osteoarthritis and Cartilage | Year: 2010

Objective: To investigate the association of different types of magnetic resonance imaging (MRI)-detected medial meniscal pathology with subregional cartilage loss in the medial tibiofemoral compartment. Methods: A total of 152 women aged ≥40 years, with and without knee osteoarthritis (OA) were included in a longitudinal 24-month observational study. Spoiled gradient recalled acquisitions at steady state (SPGR) and T2-weighted fat-suppressed MRI sequences were acquired. Medial meniscal status of the anterior horn (AH), body, and posterior horn (PH) was graded at baseline: 0 (normal), 1 (intrasubstance meniscal signal changes), 2 (single tears), and 3 (complex tears/maceration). Cartilage segmentation was performed at baseline and 24-month follow-up in various tibiofemoral subregions using computation software. Multiple linear regression models were applied for the analysis with cartilage loss as the outcome. In a first model, the results were adjusted for age and body mass index (BMI). In a second model, the results were adjusted for age, BMI and medial meniscal extrusion. Results: After adjusting for age, BMI, and medial meniscal extrusion, cartilage loss in the total medial tibia (MT) (0.04 mm, P = 0.04) and the external medial tibia (eMT) (0.068 mm, P = 0.04) increased significantly for compartments with grade 3 lesions. Cartilage loss in the total central medial femoral condyle (cMF) (0.071 mm, P = 0.03) also increased significantly for compartments with grade 2 lesions. Cartilage loss at the eMT was significantly related to tears of the PH (0.074 mm; P = 0.03). Cartilage loss was not significantly increased for compartments with grade 1 lesions. Conclusion: The protective function of the meniscus appears to be preserved in the presence of intrasubstance meniscal signal changes. Prevalent single tears and meniscal maceration were found to be associated with increased cartilage loss in the same compartment, especially at the PH. © 2009 Osteoarthritis Research Society International.

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