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Open Access 01-12-2022 | Knee Osteoarthritis | Study protocol

Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial

Authors: T. A. van Zadelhoff, A. Moelker, S. M. A. Bierma-Zeinstra, P. K. Bos, G. P. Krestin, E. H. G. Oei

Published in: Trials | Issue 1/2022

Abstract

Introduction

Knee osteoarthritis is a common disease with pain as the most prevalent symptom. Previous cohort studies have shown genicular artery embolization to reduce pain symptoms in patients with mild to moderate knee osteoarthritis. Patients resistant to conservative therapy but not eligible yet for surgical treatment due to young age or comorbidities may profit from an effective and sustained pain reduction treatment. This study is a randomized sham-controlled trial to evaluate the efficacy of genicular artery embolization in patients with knee osteoarthritis.

Methods and analysis

Fifty-eight patients with mild-to-moderate knee osteoarthritis will be recruited and randomly allocated to the treatment or control group in a 1:1 ratio. Participants in the treatment group will undergo genicular artery embolization. Patients in the control group will undergo sham treatment. Outcome measurements will be assessed at baseline and after 1, 4, 8, and 12 months with questionnaires, pressure pain threshold testing, and MR imaging. The MR imaging protocol is designed to (semi)quantitatively assess osteoarthritis in the knee joint. The primary outcome is the change from baseline of the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale after 4 months. Secondary outcomes include change in osteoarthritis-related questionnaires, pressure pain threshold, and OA-related MRI features, particularly synovitis and bone marrow lesions.

Ethics and dissemination

This trial will determine the efficacy of genicular artery embolization compared to a sham treatment. This is of importance to assess before proceeding to larger-scale efficiency studies and, ultimately, implementing this treatment into day to day clinical practice.

Trial registration

ClinicalTrials.gov NCT03884049. Registered on 21 March 2019

Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, et al. The global burden of hip and knee osteoarthritis: estimates from the Global Burden of Disease 2010 study. Annals of the Rheumatic Diseases. 2014;73(7):1323–30.CrossRef

Salmon JH, Rat AC, Achit H, Ngueyon-Sime W, Gard C, Guillemin F, et al. Health resource use and costs of symptomatic knee and/or hip osteoarthritis. Osteoarthritis Cartilage. 2019;27(7):1011–7. https://doi.org/10.1016/j.joca.2019.03.005.CrossRefPubMed

McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis and cartilage. 2014;22(3):363–88. https://doi.org/10.1016/j.joca.2014.01.003.CrossRefPubMed

Jacobson AF, Myerscough RP, Delambo K, Fleming E, Huddleston AM, Bright N, et al. Patients’ perspectives on total knee replacement. Am J Nurs. 2008;108(5):54–63 quiz -4.CrossRef

London NJ, Miller LE, Block JE. Clinical and economic consequences of the treatment gap in knee osteoarthritis management. Medical hypotheses. 2011;76(6):887–92. https://doi.org/10.1016/j.mehy.2011.02.044.CrossRefPubMed

Okuno Y, Korchi AM, Shinjo T, Kato S. Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. Cardiovasc Intervent Radiol. 2015;38(2):336–43. https://doi.org/10.1007/s00270-014-0944-8.CrossRefPubMed

Okuno Y, Korchi AM, Shinjo T, Kato S, Kaneko T. Midterm clinical outcomes and MR imaging changes after transcatheter arterial embolization as a treatment for mild to moderate radiographic knee osteoarthritis resistant to conservative treatment. J Vasc Interv Radiol. 2017;28(7):995–1002. https://doi.org/10.1016/j.jvir.2017.02.033.CrossRefPubMed

Bagla S, Piechowiak R, Hartman T, Orlando J, Del Gaizo D, Isaacson A. Genicular artery embolization for the treatment of knee pain secondary to osteoarthritis. Journal of Vascular and Interventional Radiology. 2020;31(7):1096–102. https://doi.org/10.1016/j.jvir.2019.09.018.CrossRefPubMed

Landers S, Hely R, Page R, Maister N, Hely A, Harrison B, Gill S. Genicular Artery Embolization to Improve Pain and Function in Early-Stage Knee Osteoarthritis-24-Month Pilot Study Results. J Vasc Interv Radiol. 2020;31(9):1453–1458. https://doi.org/10.1016/j.jvir.2020.05.007.

10.

Mapp PI, Walsh DA. Mechanisms and targets of angiogenesis and nerve growth in osteoarthritis. Nature reviews Rheumatology. 2012;8(7):390–8. https://doi.org/10.1038/nrrheum.2012.80.CrossRefPubMed

11.

Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis. 2008;67(12):1716–23. https://doi.org/10.1136/ard.2008.092015.

12.

Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Annals of the rheumatic diseases. 1957;16(4):494–502. https://doi.org/10.1136/ard.16.4.494.CrossRefPubMedPubMedCentral

13.

Kolahi J, Bang H Fau-Park J, Park J. Towards a proposal for assessment of blinding success in clinical trials: up-to-date review. (1600-0528 (Electronic)).

14.

Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998;28(2):88–96. https://doi.org/10.2519/jospt.1998.28.2.88.

15.

Hawker GA, Davis AM, French MR, Cibere J, Jordan JM, March L, et al. Development and preliminary psychometric testing of a new OA pain measure – an OARSI/OMERACT initiative. Osteoarthritis and Cartilage. 2008;16(4):409–14. https://doi.org/10.1016/j.joca.2007.12.015.CrossRefPubMedPubMedCentral

16.

Freynhagen R, Baron R, Gockel U, Tölle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006;22(10):1911–20. https://doi.org/10.1185/030079906X132488.

17.

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36. https://doi.org/10.1007/s11136-011-9903-x.

18.

Hudak PL, Wright JG. The characteristics of patient satisfaction measures. Spine (Phila Pa 1976). 2000;25(24):3167–77. https://doi.org/10.1097/00007632-200012150-00012.

19.

Mutlu EK, Ozdincler AR. Reliability and responsiveness of algometry for measuring pressure pain threshold in patients with knee osteoarthritis. J Phys Ther Sci. 2015;27(6):1961–5. https://doi.org/10.1589/jpts.27.1961.CrossRefPubMedPubMedCentral

20.

Hunter DJ, Guermazi A, Lo GH, Grainger AJ, Conaghan PG, Boudreau RM, et al. Evolution of semi-quantitative whole joint assessment of knee OA: MOAKS (MRI Osteoarthritis Knee Score). Osteoarthritis Cartilage. 2011;19(8):990–1002. https://doi.org/10.1016/j.joca.2011.05.004.CrossRefPubMedPubMedCentral

21.

Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. New England Journal of Medicine. 2002;347(2):81–8. https://doi.org/10.1056/NEJMoa013259.CrossRef

22.

Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, et al. OARSI recommendations for the management of hip and knee osteoarthritis: part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010;18(4):476–99. https://doi.org/10.1016/j.joca.2010.01.013.CrossRefPubMed

23.

Landers S, Hely A, Harrison B, Maister N, Hely R, Lane SE, et al. Protocol for a single-centre, parallel-arm, randomised controlled superiority trial evaluating the effects of transcatheter arterial embolisation of abnormal knee neovasculature on pain, function and quality of life in people with knee osteoarthritis. BMJ Open. 2017;7(5):e014266. https://doi.org/10.1136/bmjopen-2016-014266.CrossRefPubMedPubMedCentral

24.

Boesen M, Kubassova O, Sudoł-Szopińska I, Maas M, Hansen P, Nybing JD, Oei EH, Hemke R, Guermazi A. MR Imaging of Joint Infection and Inflammation with Emphasis on Dynamic Contrast-Enhanced MR Imaging. PET Clin. 2018;13(4):523–550. https://doi.org/10.1016/j.cpet.2018.05.007.

25.

Gait AD, Hodgson R, Parkes MJ, Hutchinson CE, O'Neill TW, Maricar N, et al. Synovial volume vs synovial measurements from dynamic contrast enhanced MRI as measures of response in osteoarthritis. Osteoarthritis Cartilage. 2016;24(8):1392–8. https://doi.org/10.1016/j.joca.2016.03.015.CrossRefPubMedPubMedCentral

Title: Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial
Authors: T. A. van Zadelhoff
A. Moelker
S. M. A. Bierma-Zeinstra
P. K. Bos
G. P. Krestin
E. H. G. Oei
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Knee Osteoarthritis
Osteoarthrosis
Magnetic Resonance Imaging
Magnetic Resonance Imaging
Osteoarthrosis
Knee Osteoarthritis
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05942-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial

Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration

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