<?xml version='1.0' encoding='UTF-8'?><xml><records><record><source-app name="HighWire" version="7.x">Drupal-HighWire</source-app><ref-type name="Journal Article">17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Neustadt, David</style></author><author><style face="normal" font="default" size="100%">Caldwell, Jacques</style></author><author><style face="normal" font="default" size="100%">Bell, Mary</style></author><author><style face="normal" font="default" size="100%">Wade, John</style></author><author><style face="normal" font="default" size="100%">Gimbel, Joseph</style></author></authors><secondary-authors></secondary-authors></contributors><titles><title><style face="normal" font="default" size="100%">Clinical effects of intraarticular injection of high molecular weight hyaluronan (Orthovisc) in osteoarthritis of the knee: a randomized, controlled, multicenter trial.</style></title><secondary-title><style face="normal" font="default" size="100%">The Journal of Rheumatology</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2005</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2005-10-01 00:00:00</style></date></pub-dates></dates><pages><style  face="normal" font="default" size="100%">1928-1936</style></pages><volume><style face="normal" font="default" size="100%">32</style></volume><issue><style face="normal" font="default" size="100%">10</style></issue><abstract><style  face="normal" font="default" size="100%">OBJECTIVE: To evaluate the efficacy and safety of injection of high molecular weight (HMW) hyaluronan (Orthovisc) in patients with mild, moderate, and severe knee osteoarthritis (OA). METHODS: A randomized, arthrocentesis-controlled, multicenter trial. Patients (n = 372) were randomized to 4 weekly HMW hyaluronan injections (O4, n = 128), 3 weekly HMW hyaluronan injections followed by one arthrocentesis (O3A1, n = 120), or 4 arthrocenteses without injection (control group, A4, n = 124). All patients had knee OA, as determined by Kellgren-Lawrence (K-L) grade, and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score &gt; or = 200 mm and &lt; 400 mm in index knee and &lt; 150 mm in contralateral knee. The primary outcome measure was the proportion of patients achieving a 20% relative and 50 mm absolute improvement from baseline in WOMAC pain score at Weeks 8, 12, 16, and 22 post-baseline in the index knee. Secondary outcomes were Patient Global score, Investigator Global score, and Pain on Standing score. RESULTS: The evaluable subgroup consisted of patients with K-L grade 2 or 3 at baseline. The comparison of O4 versus A4 for the primary outcome approached, but did not reach, significance in the evaluable subgroup: 76% of O4 patients had &gt; or = 20% improvement in WOMAC pain score at Week 8 compared to 62% of A4 patients. More O4 patients had &gt; or = 40% improvement in WOMAC pain score compared to A4. The effectiveness of the 3-injection regimen (O3A1) was masked by a possible placebo effect from the needle injection procedure in the A4 (control) group. No differences between groups were observed with respect to incidence of adverse events. CONCLUSION: Our findings indicate that HMW hyaluronan is safe and seems to be effective in the treatment of mild to severe OA of the knee.</style></abstract></record></records></xml>