Abstract
ObjectiveThe Low Molecular Weight Fraction of 5% human serum Albumin (LMWF-5A) is being investigated as a treatment for knee pain from osteoarthritis.MethodsThis was a multicenter randomized, vehicle-controlled, double-blind, parallel study designed to evaluate the safety and efficacy of two doses of an intra-articular injection of LMWF-5A. Patients with symptomatic knee osteoarthritis were randomized 1∶1∶1∶1 to receive a single 4 mL or 10 mL intra-articular knee injection of either LMWF-5A or vehicle control (saline). The primary efficacy endpoint was the difference between treatment groups in the Western Ontario and McMaster Universities (WOMAC) pain change from baseline over 12 weeks. Safety was examined as the incidence and severity of adverse events (AEs).ResultsA total of 329 patients were randomized and received treatment. LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control (−0.93 vs −0.72; estimated difference from control: −0.25, p = 0.004); an injection volume effect was not observed (p = 0.64). The effect of LMWF-5A on pain was even more pronounced in patients with severe knee OA (Kellgren Lawrence Grade IV): the estimated difference from control was −0.42 (p = 0.02). Adverse events were generally mild and were similar in patients who received vehicle control (47%) and LMWF-5A (41%).ConclusionsThis clinical trial demonstrated that LMWF-5A is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee.Trial RegistrationClinicalTrials.gov NCT01839331
Highlights
Osteoarthritis (OA) is the most common form of arthritis affecting a conservatively estimated 27 million Americans in 2008 [1]
The only evidence based treatment recommendations by the American Academy of Orthopaedic Surgeons (AAOS) for pain due to OA are selfmanagement/physical activity, weight loss, and nonsteroidal anti-inflammatory drugs (NSAIDs) or Tramadol; patients with pain that is not controlled by these recommended treatments rely on non-recommended alternatives, or eventually knee replacement [4]
Ethics statement The study was performed in accordance with the principles of good clinical practice guidelines and received institutional review board (IRB) approval from the SUNY-Buffalo Health Sciences IRB and Liberty IRB; written informed consent was obtained from all participants involved in the study
Summary
Osteoarthritis (OA) is the most common form of arthritis affecting a conservatively estimated 27 million Americans in 2008 [1]. OA is caused by inflammation of the soft tissue and bony structures of the joint which worsens over time and leads to progressive thinning of articular cartilage, narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone. These changes eventually result in chronic pain and disability, and despite drug therapy may eventually require surgery for total joint replacement [3]. There is a need for additional anti-inflammatory and analgesic treatments for OA, as the population ages and the prevalence of obesity, a contributing factor to the development of OA, continues to rise [2,5,6,7]
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