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Extended report
Relationship between bone marrow lesions, cartilage loss and pain in knee osteoarthritis: results from a randomised controlled clinical trial using MRI
  1. Lukas Martin Wildi1,
  2. Jean-Pierre Raynauld1,
  3. Johanne Martel-Pelletier1,
  4. François Abram2,
  5. Marc Dorais3,
  6. Jean-Pierre Pelletier1
  1. 1Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, Quebec, Canada
  2. 2ArthroVision, Montreal, Quebec, Canada
  3. 3StatSciences, Notre-Dame de l'Île-Perrot, Quebec, Canada
  1. Correspondence to Professor Jean-Pierre Pelletier, Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, 1560 Sherbrooke Street East, Montreal, Quebec H2L 4M1, Canada; dr{at}


Objective To assess in a multicentre randomised double-blind phase III clinical trial evaluating the effect of licofelone in comparison with naproxen on knee osteoarthritis (OA) the presence of, and change in, bone marrow lesions (BML) over time, their relationship to cartilage volume loss, meniscal extrusion and pain.

Methods Patients with knee OA were selected from the dataset of a recently published randomised controlled trial. MRI was performed at baseline, 6, 12 and 24 months to assess BML score (modified Whole-Organ MRI Score) and cartilage volume changes over time. Pain levels were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire.

Results One hundred and sixty-one patients completed the study according to protocol. The global knee and all subregions showed increased BML scores over time (p <0.001, 24 months) except for the medial tibial plateau in the licofelone group. In multivariate regression analysis, licofelone treatment predicted reduction in BML score in the medial tibial plateau (β= −0.280, p = 0.026). BML scores at baseline correlated with cartilage volume over time; however, correlation was limited to 12 months. No positive correlation was found between BML and WOMAC scores.

Conclusions BML scores were found to increase over time, probably owing to accumulation of chronic structural changes. Correlation between BML and cartilage volume was strong at baseline but not over time, probably due to the study drug. Licofelone reduced the BML score in the medial tibial plateau. In contrast to previous reports, no positive relationship was found between BML score (baseline or change over time) and pain, probably an effect of the selected population.

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  • Funding This study was supported in part by grants from Merckle GmbH (Ulm, Germany) and ArthroLab (Montreal, Quebec, Canada).

  • Competing interests LMW received a grant from the Swiss National Science Foundation. JPR is a consultant for ArthroVision. MD is a consultant for ArthroLab. JMP and JPP are consultants for and shareholders in, ArthroLab and ArthroVision. FA is an employee of ArthroVision Inc.

  • Ethics approval Approved by the local ethics committees.

  • Provenance and peer review Not commissioned; externally peer reviewed.