At twelve months, BST-CarGel treatment resulted in greater lesion filling and superior repair tissue quality compared with microfracture treatment alone. Clinical benefit was equivalent between groups at twelve months, and safety was similar.
ObjectiveThe efficacy and safety of BST-CarGel®, a chitosan scaffold for cartilage repair was compared with microfracture alone at 1 year during a multicenter randomized controlled trial in the knee. This report was undertaken to investigate 5-year structural and clinical outcomes.DesignThe international randomized controlled trial enrolled 80 patients, aged 18 to 55 years, with grade III or IV focal lesions on the femoral condyles. Patients were randomized to receive BST-CarGel® treatment or microfracture alone, and followed standardized 12-week rehabilitation. Co-primary endpoints of repair tissue quantity and quality were evaluated by 3-dimensional MRI quantification of the degree of lesion filling (%) and T2 relaxation times. Secondary endpoints were clinical benefit measured with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaires and safety. General estimating equations were used for longitudinal statistical analysis of repeated measures.ResultsBlinded MRI analysis demonstrated that BST-CarGel®-treated patients showed a significantly greater treatment effect for lesion filling (P = 0.017) over 5 years compared with microfracture alone. A significantly greater treatment effect for BST-CarGel® was also found for repair tissue T2 relaxation times (P = 0.026), which were closer to native cartilage compared to the microfracture group. BST-CarGel® and microfracture groups showed highly significant improvement at 5 years from pretreatment baseline for each WOMAC subscale (P < 0.0001), and there were no differences between the treatment groups. Safety was comparable for both groups.ConclusionsBST-CarGel® was shown to be an effective mid-term cartilage repair treatment. At 5 years, BST-CarGel® treatment resulted in sustained and significantly superior repair tissue quantity and quality over microfracture alone. Clinical benefit following BST-CarGel® and microfracture treatment were highly significant over baseline levels.
Footprints of both feet were analyzed from 1676 schoolchildren of both sexes (1013 girls and 663 boys), aged between 3 and 17 years. The sample was divided into five age groups. In each footprint the Footprint Angle and the Chippaux-Smirak Index were obtained. Classification of individual shapes of foot arches and different types of foot morphology followed that used by Jaworski and Puch in 1987. A high percentage of lowered longitudinal medial arch in the youngest age group of the study was found. The percentage is lower in the older age groups. The longitudinal medial arch has a physiological development in the earlier years of growth.
The present study analyzed the location and number of the diaphysial nutrient foramina in six long bones of adult human skeletons of unknown age and sex from a statistical view point. The diaphysial nutrient foramina in the humerus, are located at between 50 and 65% of the total length; in the radius and ulna, at between 25 and 50%; in the femur, at between 25 and 58%; in the tibia, at between 30 and 40%; and in the fibula at between 35 and 67%, i.e. the middle third of the bone. Also studied were the anatomical position and number of the diaphysial nutrient foramina in each bone.
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