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Deprecated: Implicit conversion from float 245.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 BMC+Musculoskelet+Disord 2017 ; 18 (ä): ä Nephropedia Template TP
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Structural effects of intra-articular TGF-?1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trial #MMPMID29145839
BMC Musculoskelet Disord 2017[]; 18 (ä): ä PMID29145839show ga
Background: To determine effects of allogeneic human chondrocytes expressing TGF-?1 (TG-C) on structural progression of MRI features of knee osteoarthritis over a 1 year period. Methods: This phase II randomized controlled trial of TG-C included patients with moderate to advanced osteoarthritis. Patients were randomized to receive an intraarticular 3:1 mixture of non-transduced allogeneic human chondrocytes and TG-C or placebo. 3 T MRI was acquired for all patients at baseline and follow-up (3, 6 and 12 months). MRIs were assessed using the WORMS system including cartilage damage, bone marrow lesions (BMLs), meniscal damage/extrusion, Hoffa-, effusion-synovitis, and osteophytes. Analyses were performed on a whole knee level, compartmental level, and subregional level. Binary logistic regression with Generalized Estimating Equation was used to compare risks of progression, adjusting for baseline age and gender. Mann???Whitney???Wilcoxon tests were used to assess differences for continuous variables. Results: Fifty-seven Patients were included in the TG-C group and 29 in the placebo group. At 12 months, knees in the TG-C group showed less progression of cartilage damage compared to placebo on a whole knee level (34.6% vs. 47.9%; adjusted RR 0.7, 95%CI [0.5?1.1], p?=?0.077). Less progression of Hoffa-synovitis and effusion-synovitis was observed in the TG-C group compared to placebo (9.6% vs. 21.1%, adjusted RR 0.5, 95%CI [0.2,1.2], p?=?0.115). No statistically significant differences were seen for BMLs, meniscal damage and osteophytes. Conclusions: Intraarticular treatment with TG-C showed fewer patients in the treated group with progression in structural OA features and other MRI-defined inflammatory markers such as Hoffa-synovitis and effusion-synovitis. However, no differences were observed in regard to progression of BMLs and meniscal damage, or hypertrophic osteophyte formation. Trial registration: NCT01221441.Registered 13th October, 2010