Incompliance of total hip arthroplasty (THA) patients to limited weight bearing.

INTRODUCTION: Limited weight bearing of the lower extremity is a commonly applied procedure in orthopedic rehabilitation following trauma surgery and joint replacement. The compliance of patients with limited weight bearing after cementless total hip arthroplasty has not yet been surveyed using sensor-loaded insoles. The objective of this study was to investigate foot loadings in patients after THA under the assumption of limited weight bearing. METHODS: Peak pressures for the hindfoot, midfoot and forefoot were obtained from 14 patients (10 women, 4 men, age 63 ± 12 years, height 172 ± 9 cm, weight 92 ± 20 kg, BMI 31 ± 6 kg/m(2)) by means of dynamic pedobarography, with full weight bearing preoperatively (baseline) and at 8-10 days after cementless total hip arthroplasty, walking again on even floor, and also walking upstairs and downstairs with a restriction of weight bearing to 10 % body weight, taught by an experienced physiotherapist with a bathroom scale. RESULTS: Foot loadings with limited weight bearing on even floor remained up to 88 % from full weight bearing preoperatively. Walking upstairs and downstairs under the same condition was approximately equal to a bisection of peak pressures from full weight bearing. CONCLUSIONS: Patients following cementless do not comply with limited weight bearing when they are trained by the use of a bathroom scale.

Single dose pharmacokinetics, pharmacodynamics, tolerability and safety of BAY 60-5521, a potent inhibitor of cholesteryl ester transfer protein.

AIMS: To determine pharmacokinetics (PK), pharmacodynamics (PD), tolerability and safety of BAY 60-5521, a potent inhibitor of cholesteryl ester transfer protein (CETP). METHODS: The first in man (FIM) study investigated the safety, tolerability, pharmacodynamics and pharmacokinetics in healthy male subjects following administration of single oral doses. The study was performed using a randomized, single-blind, placebo-controlled, single dose-escalation design. Thirty-eight young healthy male subjects (aged 20-45 years) received an oral dose of 5, 12.5, 25 or 50 mg BAY 60-5521 (n= 28) or were treated with a placebo (n= 10). RESULTS: In all four dose steps, only one adverse event (25 mg; mild skin rash) was considered drug related. Clinical laboratory parameters showed no clinically relevant changes. A clear dose-dependent CETP inhibition could be demonstrated starting at a dose of 5 mg. At a dose of 25 mg, a CETP inhibition >50% over 18 h was observed. After 50 mg, CETP inhibition >50% lasted more than 50 h. Twenty-four h after administration mean HDL-C-values showed a nearly dose-proportional increase. Following administration of 50 mg, a significant HDL-C increase of about 30% relative to baseline values was found. BAY 60-5521 was slowly absorbed reaching maximum concentrations in plasma after 4 to 6 h. The disposition in plasma was multi-exponential with an estimated mean terminal half-life of 76 to 144 h. CONCLUSIONS: BAY 60-5521 was clinically safe and well tolerated. No effects on heart rate, blood pressure and ECG recordings were observed during the study. A clear pharmacodynamic effect on CETP inhibition and HDL could be demonstrated.