Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Prediction of Total Knee Replacement in a Two-Year Multi-Centre Clinical Trial in Knee Osteoarthritis: Results from a 46 Year Observation.
Raynauld3, Jean-Pierre, Martel-Pelletier1, Johanne, Dorais5, Marc, Abram4, François, Haraoui2, Boulos, Choquette2, Denis, Pelletier6, Jean-Pierre
CR-CHUM, Notre-Dame Hospital, Montreal, QC, Canada
Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, QC, Canada
Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital
Research and Development, ArthroVision Inc., Montreal
StatSciences Inc., Notre-Dame de l'Ile-Perrot
University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, QC, Canada
The aim of this study was to predict, using data from quantitative magnetic resonance imaging (qMRI), the incidence of total knee replacement (TKR) during the long-term follow-up of knee OA patients who formerly received treatment with licofelone or naproxen.
Knee OA patients participating in a previous 2-year randomized, double-blind controlled trial evaluating the impact of licofelone (200 mg BID) vs. naproxen (500 mg BID) who had serial MRI acquisitions of the symptomatic knee were recently contacted to evaluate retrospectively the incidence of TKR of the study knee. A sub-group of patients (n=123) who had taken all the study medication and had all the MRI evaluations (according-to-protocol [ATP]) were selected for this post-hoc retrospective analysis. The TKR incidence was assessed blindly to the treatment allocation with a standardized phone interview.
The patients' mean age was 63.5 years, 63.5% were female and the average body mass index (BMI) was 31.9 kg/m2. A total of 18 TKRs (14.6%) were performed upon this sub-population in the time frame of 46 years after completion of the original study. Interestingly, there were significantly more TKRs performed within the naproxen group than the licofelone group (61% vs. 39%, Fischer's exact test p=0.23). Further, we investigated the predictors of long-term TKRs by comparing, within the ATP cohort, the patients who had TKR to those who did not, using data at baseline or the change at 2 years. Data revealed that baseline values of bone marrow lesions (BMLs) of the medial tibial plateau (p=0.0001; Fisher's exact test), medial joint space width (X-ray) (p=0.0008), presence of severe medial meniscal tear (p=0.004), medial meniscal extrusion (p=0.01), and C reactive protein (CRP) level (p=0.05) were strong predictors of TKR. Changes at 2 years also yielded strong predictors including change in the cartilage volume of the medial compartment (p=0.005) and of the global joint (p=0.03), as well as change in WOMAC pain (p=0.009) and function (p=0.02) scores. Logistic regressions that included age, sex, and BMI in the model, yielded that baseline severe medial tear (p=0.006) and the presence of a medial BML (p=0.002) were the strongest independent predictors of long-term TKR.
These data demonstrate that, in a knee OA clinical trial, it is possible to predict a "hard" outcome such as TKR using clinical and qMRIdata. The results are highly encouraging and support the use of qMRI as a surrogate for joint tissue damage upon which a DMOAD may act.
To cite this abstract, please use the following information:
Raynauld, Jean-Pierre, Martel-Pelletier, Johanne, Dorais, Marc, Abram, François, Haraoui, Boulos, Choquette, Denis, et al; Prediction of Total Knee Replacement in a Two-Year Multi-Centre Clinical Trial in Knee Osteoarthritis: Results from a 46 Year Observation. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :196