Abstract
OBJECTIVE: To evaluate and compare clinical efficacy and effect on specific serum biomarker with serial injections of growth factor concentrate (GFC) for knee osteoarthritis (KOA) in a randomized triple blinded placebo controlled interventional study. METHODS: Final assessment was done on 58 patients. Patients with Kellgren-Lawrence grade II, III knee osteoarthritis were administered monthly intraarticular injections(3 injections) of GFC(n = 31) or saline(n = 27) and evaluated clinically with visual analogue scale(VAS) and Western Ontario and McMaster Universities Arthritis Index(WOMAC) at 3,6 and 12 months post therapy. Biochemical analysis was done with serum biomarker of cartilage degeneration, Collagen 2-1 (Coll2-1), estimated at baseline and at final follow up. RESULTS: Both the groups exhibited statistically significant improvements (P < 0.05) in VAS at 3,6 and 12 months. WOMAC improvement reached statistical significance for GFC group at every evaluation (P < 0.001) but only at 12 months in NS group (P = 0.029). The improvements were clinically meaningful only in GFC group throughout follow up (Minimal clinically important differences >12% of baseline in WOMAC and >2 cm difference in mean for VAS). Intergroup comparison revealed GFC to be much better for both scores at every evaluation (95% CI of 0.2-1.5,[P = 0.008], 1.4-2.9,[P < 0.0001], and 2.7-4.2,[P < 0.0001] for VAS, 7.3-16.0 [P < 0.001], 11.6-21.9 [P < 0.001] and 18.1-31.1[P < 0.001] for WOMAC). Statistically significant decrease in serum Coll2-1 levels were observed for GFC group only. No serious complications were seen. CONCLUSION: Serial(three) monthly GFC injections result in clinically meaningful improvement of subjective pain and function outcome scores, sustaining up to 12 months in KOA grade II and III. GFC also lead to significant reduction in serum levels of cartilage degradation biomarker coll2-1.