Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial

Abstract

Importance: 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.

Objective: 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.

Design, setting, and participants: 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.

Interventions: Intra-articular triamcinolone (n = 70) or saline (n = 70) every 12 weeks for 2 years.

Main outcomes and measures: 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).

Results: 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%).

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT01230424.

Figure 1.. Flow of Patients With Knee Osteoarthritis Through the Study

Dropout is defined as not attending the 24-month visit. ^aPatients who scored neither a Kellgren-Lawrence (KL) grade of 2 nor 3 were excluded. ^bPatient scored 2 or higher on the weight-bearing question or 8 or less on the weight-bearing pain score according to the Western Ontario and McMaster Universities (WOMAC) index.

Figure 2.. Pain and Function Scores of Patients With Knee Osteoarthritis Treated With Triamcinolone vs Saline

See the Methods section for range definitions for pain, stiffness, and function scores measure. Data markers indicate mean, error bars, 95% CIs. P values for treatment comparisons based on multiple imputation and adjusted for sex and Kellgren-Lawrence grade are in Table 3.