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2. STRUT Study: All 40 patients with severe osteoarthritis of the knee received either 3 intra-articular injections of Ampion™ or saline into the knee in this double blinded, placebo controlled study (1:1 randomization).
The primary and secondary endpoints (WOMAC A for pain, WOMAC B for stiffness and WOMAC C for function) results at 20 weeks (end of FDA study) will be available in the first quarter of 2015. The study will however continue to 52 weeks to evaluate cartilage markers both by MRIs and synovial fluid proteomics. |
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