Tibial nailing using a suprapatellar rather than an infrapatellar approach significantly reduces anterior knee pain postoperatively: a multicentre clinical trial.

AIMS: The aim of this study was to compare the incidence of anterior knee pain after antegrade tibial nailing using suprapatellar and infrapatellar surgical approaches. PATIENTS AND METHODS: A total of 95 patients with a tibial fracture requiring an intramedullary nail were randomized to treatment using a supra- or infrapatellar approach. Anterior knee pain was assessed at four and six months, and one year postoperatively, using the Aberdeen Weightbearing Test - Knee (AWT-K) score and a visual analogue scale (VAS) score for pain. The AWT-K is an objective patient-reported outcome measure that uses weight transmitted through the knee when kneeling as a surrogate for anterior knee pain. RESULTS: A total of 53 patients were randomized to a suprapatellar approach and 42 to an infrapatellar approach. AWT-K results showed a greater mean proportion of weight transmitted through the injured leg compared with the uninjured leg when kneeling in the suprapatellar group compared with the infrapatellar group at all timepoints at all follow-up visits. This reached significance at four months for all timepoints except 30 seconds. It also reached significance at six months at 0 seconds, and for one year at 60 seconds. CONCLUSION: The suprapatellar surgical approach for antegrade tibial nailing is associated with less anterior knee pain postoperatively compared with the infrapatellar approach Cite this article: Bone Joint J 2019;101-B:1138-1143.

A novel testosterone gel formulation normalizes androgen levels in hypogonadal men, with improvements in body composition and sexual function.

OBJECTIVE: To compare the safety and efficacy of two doses of a new testosterone gel formulation (Testim Auxilium Pharmaceuticals, Inc., Norristown, PA, USA) to a permeation-enhanced testosterone patch (Andropatch), GlaxoSmithKline, UK) for treating men with confirmed low serum testosterone levels, and associated signs and symptoms of hypogonadism. PATIENTS AND METHODS: In all, 208 men were randomized and treated at 29 centres in Denmark, Germany, Netherlands, Sweden and the UK. The men were treated for 90 days, and the pharmacokinetics and treatment effectiveness of Testim at two doses (50 and 100 mg/day, delivering a daily dose of 5 and 10 mg testosterone, respectively) and Andropatch (2 x 2.5 mg patches, each delivering 2.5 mg testosterone and containing 12.2 mg of testosterone) were compared. Pharmacokinetic profiles were obtained, body composition measured, and mood and sexual function data recorded. RESULTS: Testim produced dose-dependent improvements in all pharmacokinetic variables compared with Andropatch. The mean increases from baseline to 90 days in testosterone were 12.41, 6.54 and 3.82 nmol/L for Testim 100 and 50 mg/day and the Andropatch, respectively. Both doses of Testim significantly improved positive and negative mood over baseline; Andropatch did not. All three treatments increased lean body mass, and the higher dose of Testim produced a significant decrease in percentage body fat. At all sample times both doses of Testim significantly improved sexual performance, sexual motivation, sexual desire and spontaneous erections. Andropatch provided insignificant improvements from baseline at all sample times for sexual desire, an inconsistent improvement in sexual motivation, but no effect on spontaneous erections. These results are similar to those previously reported for testosterone replacement therapy in hypogonadal men, suggesting that normalization of serum testosterone restores sexual function. However, the present data suggest that higher serum testosterone levels may further improve sexual function. Gel treatment was well tolerated, while patch treatment produced higher rates of application-site reactions and study discontinuation. CONCLUSION: The favourable pharmacokinetic profile and treatment outcome, combined with the enhanced tolerability of Testim, suggest that this new gel formulation is a safe and effective treatment in men with low serum testosterone levels and associated signs and symptoms of hypogonadism.

Safety and efficacy of temafloxacin versus ciprofloxacin in lower respiratory tract infections: a randomized, double-blind trial.

Temafloxacin, a new fluoroquinolone with broad-spectrum anti-bacterial activity and a favourable pharmacokinetic profile, was evaluated in a prospective, randomized double-blind multicentre study in which 564 patients were enrolled. Ambulatory adults with lower respiratory tract infections were randomly assigned to receive temafloxacin 600 mg or ciprofloxacin 750 mg, each given every 12 h for 7-14 days. Cure or improvement occurred in 93.8% of temafloxacin patients and 93.1% of ciprofloxacin recipients (P greater than 0.05). Bacteriological eradication rates were higher in the temafloxacin group than in the ciprofloxacin group (99.5% vs 92.5%; P = 0.001) primarily because of the failure of ciprofloxacin to eradicate Streptococcus pneumoniae (P = 0.01). Both regimens were well tolerated. In patients who received concomitant theophylline, gastrointestinal and central nervous system disturbances occurred in a higher percentage of patients in the ciprofloxacin group than the temafloxacin group (36.4% vs 9.4%; P less than 0.05). This study indicates that temafloxacin would be suitable for the empirical treatment of lower respiratory tract infections, including high-risk groups such as the elderly and heavy smokers.

A comparative safety and efficacy study of clarithromycin and erythromycin stearate in community-acquired pneumonia.

The efficacy and tolerance of clarithromycin and erythromycin stearate in the treatment of community-acquired pneumonia were compared in a multicentre, double-blind randomized trial. Two hundred and eight adult patients were randomized to receive either clarithromycin 250 mg 12-hourly (96 patients) or erythromycin stearate 500 mg 6-hourly (112 patients), each for 14 days. One hundred and eight patients were evaluable for efficacy, 64 receiving clarithromycin and 44 erythromycin stearate. There was no significant difference between the two groups in terms of clinical cure (52% for clarithromycin, 40% for erythromycin) or clinical success (clinical cure and improvement; 89% for clarithromycin, 98% for erythromycin stearate), or radiological response (90% for both groups). An intention-to-treat analysis, including all patients entering the study revealed significant differences in favour of clarithromycin. The clinical cure rate after two weeks of treatment was 45% in those who received clarithromycin compared with 25% in the erythromycin stearate group (P = 0.003), whilst improvement in cough was observed in 97% and 80% of patients receiving clarithromycin and erythromycin stearate, respectively (P = 0.07). Adverse effects, mainly gastrointestinal, caused discontinuation of treatment in 4% (4/96) patients in the clarithromycin group in comparison with 19% (21/112) treated with erythromycin stearate (P less than 0.01). These results demonstrate that clarithromycin twice daily is at least as effective as four times daily erythromycin stearate for the treatment of community-acquired pneumonia and is better tolerated.

Comparison of oral erythromycin ethylsuccinate and ciprofloxacin in the treatment of acute respiratory tract infections.

A total of 619 patients with acute upper or lower respiratory tract infection were randomised to receive either erythromycin ethylsuccinate tablets at a dose of 1 g twice daily, or ciprofloxacin tablets 500 mg twice daily in a single-blind, multicentre study. The efficacy of each antibacterial was similar, with close to 90% of patients on each treatment being reported as either cured or improved. Gastrointestinal symptoms were the most commonly reported side-effects, being similar in overall incidence for both agents. Nausea, vomiting, dizziness and headache occurred more frequently in the ciprofloxacin group, while abdominal pain and diarrhoea occurred more frequently in the erythromycin ethylsuccinate group. In each group, the number of patients failing to complete treatment was similar and the main reasons cited for discontinuation were gastrointestinal symptoms. This study indicates that both erythromycin ethylsuccinate and ciprofloxacin are well tolerated and are equally effective for routine empirical treatment of acute respiratory tract infections.