CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures.

BACKGROUND: Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical study investigates the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fractures-associated bone defects using either autologous bone grafting or bioresorbable hydroxyapatite/calcium sulphate cement (CERAMENT™|BONE VOID FILLER (CBVF)). METHODS/DESIGN: CERTiFy (CERament™ Treatment of Fracture defects) is a prospective, multicenter, controlled, randomized trial. We plan to enroll 136 patients with fresh traumatic depression fractures of the proximal tibia (types AO 41-B2 and AO 41-B3) in 13 participating centers in Germany. Patients will be randomized to receive either autologous iliac crest bone graft or CBVF after reduction and osteosynthesis of the fracture to reconstruct the subchondral bone defect and prevent the subsidence of the articular surface. The primary outcome is the SF-12 Physical Component Summary at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and costs of care will serve as key secondary endpoints. The study is designed to show non-inferiority of the CBVF treatment to the autologous iliac crest bone graft with respect to the physical component of quality of life. The pain level at 26 weeks after surgery is expected to be lower in the CERAMENT bone void filler treatment group. DISCUSSION: CERTiFy is the first randomized multicenter clinical trial designed to compare quality of life, pain, and cost of care in the use of the CBVF and the autologous iliac crest bone graft in the treatment of tibia plateau fractures. The results are expected to influence future treatment recommendations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT01828905.

Differential growth and yield by canola (Brassica napus L.) and wheat (Triticum aestivum L.) arising from alterations in chemical properties of sandy soils due to additions of fly ash.

BACKGROUND: There is a need for field trials on testing agronomic potential of coal fly ash to engender routine use of this technology. Two field trials were undertaken with alkaline and acidic fly ashes supplied at between 3 and 6 Mg ha⁻¹ to acidic soils and sown to wheat and canola at Richmond (Eastern Australia) and to wheat only at Merredin (Western Australia). RESULTS: Ash addition marginally (P< 0.10) raised the pH in the top soil layers at both sites. The exceptionally dry season at both sites constrained yields and thwarted any likelihood of gaining yield benefits from ash-induced improvements in soil conditions. Yield improvements due to ash addition were absent at Merredin and only marginal at Richmond, where no elevated accumulation of B, Mo, Se, P or S in either the straw or seeds of wheat was observed; canola increased accumulation of Mo and Se in its shoot with acidic fly ash, but it was well below phyto toxic levels. Simulations of wheat using APSIM at Richmond over a 100-year period (1909-2008) predicted yield increases in 52% of years with addition of ash at 3.0 Mg ha⁻¹ compared with 24% of years with addition of ash at 6.0 Mg ha⁻¹. The simulated yield increases did not exceed 40% over the control with addition of 6 Mg ha⁻¹ ash, but was between 40% and 50% with an addition rate of 3 Mg ha⁻¹. CONCLUSION: We found no evidence of phytotoxicity in either crop in this unusually dry year and there is still a need for further field assessment in years with favourable rainfall to enable development of clear recommendations on fly ash rates for optimum yield benefits.

Influence of calcium and silicon supplementation into Pleurotus ostreatus substrates on quality of fresh and canned mushrooms.

Supplements of gypsum (calcium source), pumice (silicon source) and pumice sulfate (silicon and calcium source) into substrates for oyster mushrooms (Pleurotus ostreatus) were searched for their effects on production as well as qualities of fresh and canned mushrooms. The addition of pumice up to 30% had no effect on total yield, size distribution and cap diameters. The supplementation of gypsum at 10% decreased the total yield; and although gypsum at 5% did not affect total yield, the treatment increased the proportion of large-sized caps. High content (>10%) of pumice sulfate resulted in the lower yield. Calcium and silicon contents in the fruit bodies were not influenced by supplementations. The centrifugal drip loss values and solid content of fresh mushrooms, and the percentage of weight gained and firmness of canned mushrooms, cultivated in substrates supplemented with gypsum, pumice and pumice sulfate were significantly (p≤0.05) higher than those of the control. Scanning electron micrographs revealed the more compacted hyphae of mushroom stalks supplemented with silicon and/or calcium after heat treatment, compared to the control. Supplementation of P. ostreatus substrates with 20% pumice was the most practical treatment because it showed no effect on yield and the most cost-effective.