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- Title
Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial.
- Authors
McAlindon, Timothy E.; Harvey, William F.; Driban, Jeffrey B.; Ming Zhang; LaValley, Michael P.; Price, Lori Lyn; Ward, Robert J.; Zhang, Ming
- Abstract
<bold>Importance: </bold>Synovitis is common and is associated with progression of structural characteristics of knee osteoarthritis. Intra-articular corticosteroids could reduce cartilage damage associated with synovitis but might have adverse effects on cartilage and periarticular bone.<bold>Objective: </bold>To determine the effects of intra-articular injection of 40 mg of triamcinolone acetonide every 3 months on progression of cartilage loss and knee pain.<bold>Design, Setting, and Participants: </bold>Two-year, randomized, placebo-controlled, double-blind trial of intra-articular triamcinolone vs saline for symptomatic knee osteoarthritis with ultrasonic features of synovitis in 140 patients. Mixed-effects regression models with a random intercept were used to analyze the longitudinal repeated outcome measures. Patients fulfilling the American College of Rheumatology criteria for symptomatic knee osteoarthritis, Kellgren-Lawrence grades 2 or 3, were enrolled at Tufts Medical Center beginning February 11, 2013; all patients completed the study by January 1, 2015.<bold>Interventions: </bold>Intra-articular triamcinolone (n = 70) or saline (n = 70) every 12 weeks for 2 years.<bold>Main Outcomes and Measures: </bold>Annual knee magnetic resonance imaging for quantitative evaluation of cartilage volume (minimal clinically important difference not yet defined), and Western Ontario and McMaster Universities Osteoarthritis index collected every 3 months (Likert pain subscale range, 0 [no pain] to 20 [extreme pain]; minimal clinically important improvement, 3.94).<bold>Results: </bold>Among 140 randomized patients (mean age, 58 [SD, 8] years, 75 women [54%]), 119 (85%) completed the study. Intra-articular triamcinolone resulted in significantly greater cartilage volume loss than did saline for a mean change in index compartment cartilage thickness of -0.21 mm vs -0.10 mm (between-group difference, -0.11 mm; 95% CI, -0.20 to -0.03 mm); and no significant difference in pain (-1.2 vs -1.9; between-group difference, -0.6; 95% CI, -1.6 to 0.3). The saline group had 3 treatment-related adverse events compared with 5 in the triamcinolone group and had a small increase in hemoglobin A1c levels (between-group difference, -0.2%; 95% CI, -0.5% to -0.007%).<bold>Conclusions and Relevance: </bold>Among patients with symptomatic knee osteoarthritis, 2 years of intra-articular triamcinolone, compared with intra-articular saline, resulted in significantly greater cartilage volume loss and no significant difference in knee pain. These findings do not support this treatment for patients with symptomatic knee osteoarthritis.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT01230424.
- Subjects
TRIAMCINOLONE; PAIN management; SYNOVITIS; PATIENTS; DIAGNOSIS; THERAPEUTICS; ANTI-inflammatory agents; CARTILAGE; COMPARATIVE studies; DRUG administration; GLUCOCORTICOIDS; GLYCOSYLATED hemoglobin; INTRA-articular injections; KNEE diseases; MAGNETIC resonance imaging; RESEARCH methodology; MEDICAL cooperation; OSTEOARTHRITIS; HEALTH outcome assessment; QUESTIONNAIRES; REGRESSION analysis; RESEARCH; RESEARCH funding; SALT; SAMPLE size (Statistics); EVALUATION research; RANDOMIZED controlled trials; BLIND experiment; JOINT pain; DISEASE complications
- Publication
JAMA: Journal of the American Medical Association, 2017, Vol 317, Issue 19, p1967
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2017.5283