In a prospective randomised clinical study acetabular components were implanted either freehand (n = 30) or using CT-based (n = 30) or imageless navigation (n = 30). The position of the component was determined post-operatively on CT scans of the pelvis. Following conventional freehand placement of the acetabular component, only 14 of the 30 were within the safe zone as defined by Lewinnek et al (40 degrees inclination sd 10 degrees ; 15 degrees anteversion sd 10 degrees ). After computer-assisted navigation 25 of 30 acetabular components (CT-based) and 28 of 30 components (imageless) were positioned within this limit (overall p < 0.001). No significant differences were observed between CT-based and imageless navigation (p = 0.23); both showed a significant reduction in variation of the position of the acetabular component compared with conventional freehand arthroplasty (p < 0.001). The duration of the operation was increased by eight minutes with imageless and by 17 minutes with CT-based navigation. Imageless navigation proved as reliable as that using CT in positioning the acetabular component.

for the 990757 Study GroupObjective. To evaluate the safety of anakinra (a recombinant human interleukin-1 receptor antagonist) in a large population of patients with rheumatoid arthritis (RA), typical of those seen in clinical practice.Methods. A total of 1,414 patients were randomly assigned to treatment with 100 mg of anakinra or placebo, administered daily by subcutaneous injection. Background medications included disease-modifying antirheumatic drugs, corticosteroids, and nonsteroidal antiinflammatory drugs, alone or in combination. The primary end point was safety, which was evaluated by adverse events (including infections), discontinuation from study due to adverse events, and death.Results. Safety was evaluated in 1,399 patients (1,116 in the anakinra group and 283 in the placebo group; 15 patients were randomized but did not receive any study drug) during the initial 6-month, doubleblind, placebo-controlled phase of this long-term safety study. Baseline demographics, disease characteristics, and concomitant medications were similar between the 2 groups. The study group included patients with numerous comorbid conditions and a wide range of RA disease activity. Serious adverse events occurred at a similar rate in the anakinra group and the placebo group (7.7% and 7.8%, respectively). Serious infectious episodes were observed more frequently in the anakinra group (2.1% versus 0.4% in the placebo group). The rate of withdrawal due to adverse events was 13.4% in the anakinra group and 9.2% in the placebo group.Conclusion. Results from this large, placebocontrolled safety study demonstrate that anakinra is safe and well tolerated in a diverse population of patients with RA, including those with comorbid conditions and those using multiple combinations of concomitant therapies. Although the frequency of serious infection was slightly higher in the anakinra group, no infection was attributed to opportunistic microorganisms or resulted in death.

Objective. To identify the cells that express transcription factor NF-KB subunits p50 and p65 in synovial tissue from patients with rheumatoid arthritis (RA) and to correlate the distribution of p50 and p65 with CD14 (macrophage lipopolysaccharide receptor) and members of the AP-1 transcription factor family, Jun and Fos.Methods. Immunohistochemistry was used to identify p50, p65, Jun and Fos in sections of synovial tissue from 13 patients with RA and 4 "normal" control subjects. Double staining for CD14 and each of the transcription factor subunits was performed.Results. Subunits p50 and p65 were present in the nuclei of synovial cells in all 13 RA patients, with expression varying from rare cells to more than half of all cells. In most cases, nuclear p50 and p65 were present in approximately one-third of synovial lining cells and in a variable proportion of cells scattered throughout the sublining region, including the endothelium. The distributions of p50 and p65 were similar. Jun and Fos were present in the nuclei of a large proportion of synovial lining cells with significantly less expression elsewhere. In each case the Jun/Fos distribution was clearly different from the p50/p65 distribution, although there was significant overlap in many cases. Cells expressing CD14 were mostly JunlFos negative and were predominantly pSO/p65 positive.

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