A New Clinically Relevant T-Score Standard to Interpret Bone Status in a Sheep Model.

BACKGROUND Osteoporosis is diagnosed by bone loss using a radiological parameter called T-score. Preclinical studies use DXA to evaluate bone status were the T-score is referenced on bone mineral density (BMD) values of the same animals before treatment. Clinically, the reference BMD represents values of an independent group of healthy patients around 30 years old. The present study established a clinically similar T-score standard to diagnose osteoporosis in a sheep model. MATERIAL AND METHODS We used 31 female merino land sheep (average 5.5 years old) to study osteoporosis. The following groups were compared using DXA measurement: 1) control; 2) ovariectomized (OVX); 3) OVX combined with a deficient diet (OVXD); and 4) OVXD combined with methylprednisolone administration (OVXDS). Further, an independent group of 32 healthy sheep (4-6 years old) were measured as an independent baseline. BMD was measured at 0 months, 3 months, and 8 months after treatment. RESULTS The same significance pattern between the treated groups and either baseline groups was seen. However, using an independent baseline changed the "clinical" interpretation of the data from an osteoporotic bone status (T-score <-2.5) after 3 months of OXDS treatment into an osteopenic bone status (T-score <-1.5 to -2.4). CONCLUSIONS Using an independent baseline enhanced the statistical significance and showed the clinical relevance. Furthermore, an independent baseline is a reliable alternative to use of a new control group for future experiments and thus reduces the number of animals needed by eliminating the need for a control and corresponding to clinical practice.

A novel, hydroxyapatite-based screw-like device for anterior cruciate ligament (ACL) reconstructions.

BACKGROUND: Rupture of the anterior cruciate ligament (ACL) is one of the most common injuries of the knee. Common techniques for ACL reconstruction require a graft fixation using interference screws. Nowadays, these interference screws are normally made of titanium or polymer/ceramic composites. The main challenge of application of a fixation device made entirely of bioactive ceramic is in relation to the low strength of such materials. The purpose of this study was to evaluate a novel geometry for a fixation device made of pure hydroxyapatite for ACL reconstructions that can overcome some problems of the titanium and the polymer/ceramic screws. METHODS: Finite Element Analysis was used for optimization of the stress distribution in conventional interference screw geometry. For experimental evaluation of the new fixation device, ex vivo tests were performed. RESULTS: The innovative screw-like fixation device is characterized by multiple threads with a large thread pitch. The novel design enabled the insertion of the screw into the bone without the application of an external torque or a screwdriver. In turn, it also allowed for the use of low-strength and high-bioactivity materials, like hydroxyapatite. Ex vivo tests showed that the novel screw can sustain pull-out forces up to 476 N, which is comparable to that of the commercially available BioComposite™ interference screws (Arthrex Inc., Germany), as a reference. CONCLUSIONS: In summary, the novel screw design is a promising strategy to develop all-ceramic fixation devices for ACL reconstructions, which may eliminate some drawbacks of the current interference screws.