Article (Scientific journals)
EUROVISCO Guidelines for the Design and Conduct of Clinical Trials Assessing the Disease-Modifying Effect of Knee Viscosupplementation
Henrotin, Yves; Chevalier, Xavier ; Raman, Raghu N. et al.
2018In Cartilage
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Keywords :
MRI
Abstract :
[en] Objectives: Hyaluronic acid viscosupplementation is a commonly used intra-articular treatment for osteoarthritis (OA). Some recent preclinical and clinical trials have demonstrated a potential for its disease-modifying effects. The goal of this expert opinion, consensus-driven exercise is to provide guidelines for the design and conduct of clinical trials assessing the disease-modifying effect of viscosupplementation in the knee. Methods: The EUROVISCO group constitutes 10 members who had expertise in clinical research methodology in the field of OA and viscosupplementation. They initially drafted issues through an iterative process and had to vote on their degree of agreement on these recommendations. The scores were pooled to generate a median agreement score for each recommendation. Results: The document includes 31 recommendations regarding study population, imaging, clinical and biological assessment of disease-modifying effects of viscosupplementation. Agreements were reached on some recommendations. In particular, the experts reached unanimous agreement on double-blind study design, imaging primary outcomes, time interval between 2 radiographs, x-ray procedure standardization, and the combined use of imaging and biological markers. The group did not recommend the use of ultrasonography, computed tomography (CT) scan and CT arthrography as a tool for OA diagnosis or to assess progression over time. Conclusion: In summary, the working group identified 31 recommendations that represent the current best practices regarding clinical trials that target the assessment of viscosupplementation disease-modifying effects in patients with knee OA. These recommendations integrate new imaging technologies and soluble biomarkers. © 2018, The Author(s) 2018.
Disciplines :
Rheumatology
Author, co-author :
Henrotin, Yves  ;  Université de Liège - ULiège > Département des sciences de la motricité > Unité de recherche sur l'os et le cartilage (U.R.O.C.)
Chevalier, Xavier ;  Paris XII University, UPEC, Department of Rheumatology, Henri Mondor Hospital, Creteil, France
Raman, Raghu N.;  Academic Department of Orthopaedics, Hull and East Yorkshire NHS Trust, Castle Hill Hospital, Cottingham, UK
Richette, Pascal;  Université Paris Diderot, UFR Médicale, Hôpital Lariboisière, Paris, France
Montfort, Jordi;  Servei de Reumatologia, Hospital del Mar, Parc de Salut Mar, Barcelona, Catalonia, Spain
Jerosch, Joerg G.;  Orthopedic Department, Johanna-Etienne-Hospital, Neuss, Nordrhein-Westfalen, Germany
Baron, Dominique;  Centre de réadaptation fonctionnelle de Lannion-Trestel, Trévou-Tréguignec, France
Bard, Hervé;  Department of Rheumatology, Hôpital Européen Georges-Pompidou, Paris, France
Carrillon, Yannick;  Department of Radiology, Centre Orthopédique Santy, Lyon, France
Migliore, Alberto;  U.O.S. of Rheumatology, Ospedale San Pietro Fatebenefratelli, Rome, Italy
Conrozier, Thierry;  Department of Rheumatology, Hôpital Nord Franche-Comté, Belfort, France
Language :
English
Title :
EUROVISCO Guidelines for the Design and Conduct of Clinical Trials Assessing the Disease-Modifying Effect of Knee Viscosupplementation
Publication date :
2018
Journal title :
Cartilage
ISSN :
1947-6035
eISSN :
1947-6043
Publisher :
SAGE Publications Inc.
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 07 January 2019

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