Randomized double-blind placebo-controlled trial on the potential modes of action of SheaFlex70 in osteoarthritis.

Extracts from the seed of the African shea tree Vitellaria paradoxa C.F. Gaertn have been used traditionally for the treatment of arthritic conditions. However, little is known about the mechanisms by which benefit is conferred. This single-site, 15-week randomized, double-blind, parallel, placebo-controlled study examined a range of biomarkers in 89 patients with osteoarthritis of the knees and/or hips to determine potential modes of action of SheaFlex70, a triterpene-rich extract of Vitellaria paradoxa. In the group of participants with levels of osteoarthritis biomarkers in the upper quartile at baseline, there were significant decreases in inflammation and cartilage breakdown and trend level decreases in bone remodeling in the SheaFlex70 group versus placebo between commencement and completion of the study. Inflammation marker TNF-alpha fell 23.9% vs 6% (treatment vs placebo), p = 0.041. Cartilage degradation marker CTX-II fell 28.7% vs an increase of 17.6% (treatment vs placebo), p = 0.018. This marker also showed significant falls across the entire study group, 10.6% vs an increase of 11.6%, (treatment vs placebo), p = 0.016. Osteocalcin levels fell 9.2%, p = 0.014 (treatment) vs 1.2%, ns (placebo), p = 0.096 (treatment vs placebo). These findings indicate that in patients with the highest levels of osteoarthritis biomarkers, SheaFlex70 demonstrated multiple beneficial activities consistent with slowing the disease process.

Pore distribution and material properties of bone cement cured at different temperatures.

Implant heating has been advocated as a means to alter the porosity of the bone cement/implant interface; however, little is known about the influence on cement properties. This study investigates the mechanical properties and pore distribution of 10 commercially available cements cured in molds at 20, 37, 40 and 50 degrees Celsius. Although each cement reacted differently to the curing environments, the most prevalent trend was increased mechanical properties when cured at 50 degrees Celsius vs. room temperature. Pores were shown to gather near the surface of cooler molds and near the center in warmer molds for all cement brands. Pore size was also influenced. Small pores were more often present in cements cured at cooler temperatures, with higher-temperature molds producing more large pores. The mechanical properties of all cements were above the minimum regulatory standards. This work shows the influence of curing temperature on cement properties and porosity characteristics, and supports the practice of heating cemented implants to influence interfacial porosity.