Low-dose deflazacort reduces postoperative pain and inflammation following primary total knee arthroplasty: A randomized controlled trial.

INTRODUCTION

Postoperative pain, inflammation, and sleep disturbance remain major challenges following total knee arthroplasty (TKA). While perioperative corticosteroids have demonstrated benefits, the role of extended low-dose oral corticosteroid therapy during postoperative recovery is not well defined. Therefore, this study aimed to evaluate the efficacy and safety of low-dose oral deflazacort in reducing postoperative pain and improving sleep quality following primary TKA. The hypothesis was that perioperative low-dose deflazacort would reduce postoperative pain and improve functional recovery compared to placebo.

METHODS

In this prospective, double-blind, placebo-controlled trial, 100 patients undergoing unilateral primary TKA for osteoarthritis were randomized to receive either oral deflazacort 6 mg daily (n = 50) or placebo (n = 50) for 3 weeks postoperatively. Primary outcomes included visual analog scale (VAS) pain scores at rest and during mobilization, and Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes included Oxford Knee Score (OKS), inflammatory markers (erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], interleukin-6 [IL-6]), and thermographic assessment of local knee temperature. Longitudinal outcomes were analyzed using linear mixed-effects models.

RESULTS

VAS pain scores at rest were statistically significantly lower in the deflazacort group at 3 months (0.94 vs 1.18; p = 0.033) and during mobilization at 1 month (3.38 vs 3.85; p = 0.035) and 3 months (1.98 vs 2.31; p = 0.010). However, absolute differences did not exceed established minimal clinically important difference (MCID) thresholds. Sleep quality was superior in the deflazacort group at 3 months (PSQI: 9.44 vs 10.42; p = 0.028). The OKS was statistically significant in the deflazacort group at 1 and 3 months (p = 0.003 and p = 0.04, respectively). Inflammatory markers demonstrated statistically significant lower values in the deflazacort group at 3 months including ESR, CRP, and IL-6 (all p < 0.01). Peak skin temperature was statistically significantly lower in the deflazacort group at 1 and 3 months (p < 0.001). No steroid-related adverse events were observed in terms of safety.

CONCLUSION

Low-dose oral deflazacort following primary TKA was associated with modest but consistent improvements in pain, function, sleep quality, and inflammatory markers, with an excellent safety profile. Although clinical improvements did not exceed MCIDs, the findings suggest that low-dose deflazacort may serve as a safe adjunct in multimodal postoperative recovery protocols with potential implications for reducing opioid consumption and improving patient satisfaction.

LEVEL OF EVIDENCE: I, Randomized controlled trial.