Background. The aim was to evaluate the analgesic efficacy and safety of the dexketoprofen/tramadol 25 mg/75 mg fixed-dose combination vs dexketoprofen (25 mg) and tramadol (100 mg) in moderate-to-severe acute pain after total hip arthroplasty.Methods. This was a randomized, double-blind, parallel-group study in patients experiencing pain of at least moderate intensity on the day after surgery, compared with placebo at first administration to validate the pain model. The study drug was administered orally every 8 h throughout a 5 day period. Rescue medication, metamizole 500 mg, was available during the treatment period. The evaluation of efficacy was based on patient assessments of pain intensity and pain relief. The primary end point was the mean sum of the pain intensity difference values throughout the first 8 h (SPID8).Results. Overall, 641 patients, mean age 62 (range 29–80) yr, were analysed; mean (sd) values of SPID8 were 247 (157) for dexketoprofen/tramadol, 209 (155) for dexketoprofen, 205 (146) for tramadol, and 151 (159) for placebo. The primary analysis confirmed the superiority of the combination over dexketoprofen 25 mg (P=0.019; 95% confidence interval 6.4–73) and tramadol 100 mg (P=0.012; 95% confidence interval 9.5–76). The single components were superior to placebo (P<0.05), confirming model sensitivity. Most secondary analyses supported the superiority of the combination. The incidence of adverse drug reactions was low and similar among active treatment groups.Conclusion. The efficacy results confirmed the superiority of dexketoprofen/tramadol over its single components, even at higher doses (tramadol), with a safety profile fully in line with that previously known for these agents in monotherapy.Clinical trial registration. EudraCT 2012-004548-31 ();ClinicalTrials.gov NCT01902134 ().
Worldwide, there are millions of patients each year suffering from bone-related illness due to trauma, degenerative diseases, infections or oncology that require orthopaedic intervention involving bone grafts. This literature review aims to analyse the characteristics of the different bone grafts: autografts, allografts and synthetic bone substitutes. The review will assess their medical value based on their effectiveness as well as scrutinising any drawbacks. The goal is to identify which options can give the optimal result for a patient being treated for a bone defect.Bone autografts remain the gold standard since there are no issues with histocompatibility or disease transmission while possessing the ideal characteristics: osteogenicity, osteoconductivity and osteoinductivity. However, synthetic options such as calcium phosphate ceramics are becoming popular as a viable alternative for treatment since they can be produced in desired quantitates and yield excellent results while not having the problem of donor site morbidity as seen with autografts. Furthermore, advancements in fields such as bone tissue engineering and three-dimensional printing are generating promising results and could provide a path for excellent treatment in the future. The emergence of such innovations highlights the importance and the constant need for improvement in bone grafting.
Calcium bone substitutes are successfully used for local recovery of osteoporotic bone and filling of bone defects. Previous studies revieled that biphasic calcium phosphate (BCP) show better bioactivity in compare to pure β-tricalcium phosphate or hydroxyapatite. Also increased porosity of material promotes better bone tissue response. Aim of this experiment was to evaluate immunohistologically response of osteoporotic bone of experimental animal to implantation of granules with hydroxyapatite/β-tricalcium phosphate (HAp/β-TCP) ratio of 90/10. Calcium phosphate (CaP) was synthesized by aqueous precipitation technique from calcium hydroxide and phosphoric acid. Bioceramic granules in size range from 1.0 to 1.4 mm were prepared with nanopore sizes around 200 nm. We used nine female rabbits with induced osteoporosis in this experiment. Six animals in study group underwent implantation of BCP in hip bone defect and three animals in control group left without BCP implantation. After 6 months animals were euthanized, bone samples collected and proceeded for detection of bone activity and repair markers: osteocalcin (OC), osteopontin (OP) and osteoprotegerin (OPG). Controls showed the presence of experimental bone osteoporosis. In experimental group bone showed partially resorbed bioceramic granules and in some samples new bone formation near the granuli was observed. Increase of OC and OPG up to twice as to compare to control group were detected as well. Implantation of BCP granules in osteoporotic rabbit bone increases expression of OC and OPG indicating the activation of osteoblastogenesis and bone mineralization in vivo.
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