[Recovery of knee function after total knee arthroplasty: different outcomes in patients with osteoarthritis and rheumatoid arthritis]. / Gelenkfunktion nach bikondylärer Knieendoprothese: Unterschiedlicher Verlauf bei Patienten mit Gonarthrose und rheumatoider Arthritis.

INTRODUCTION: Following total knee arthroplasty (TKA), no investigations have been published to assess possible differences between rheumatoid arthritic (RA) and osteoarthritic (OA) patients with respect to patient-reported outcome measures of knee function. PATIENTS AND METHODS: A cohort of 128 consecutively operated patients (OA: n = 92, RA: n = 36) treated with bicondylar TKA was included in this prospective, clinical study. Knee function was assessed preoperatively and at 6 and 12 months after TKA, using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Oxford Knee Score (OKS). RESULTS: Both OKS and KOOS revealed a statistically significant improvement for OA and RA patients at 6 and 12 months after surgery, as compared to the preoperative status. The results of the OKS at 6 and 12 months did not show a further improvement for either group. The KOOS, however, revealed an additional improvement between 6 and 12 months for the osteoarthritis group, regarding the total score and all subscores, but not for the RA subgroup. CONCLUSION: Functional recovery after TKA improves in the second 6 months after surgery in OA patients, but not in RA patients, when knee function is exclusively assessed with patient-reported outcome measures.

Orientation of human osteoblasts on hydroxyapatite-based microchannels.

The effect of calcium phosphate-based microchannels on the growth and orientation of human osteoblast cells is investigated in this study. As substrates, hydroxyapatite-based microchannels with high contouring accuracy were fabricated by a novel micro-moulding technique. Microchannels obtained by this method featured widths ranging from 16.0±0.7 to 76.6±1.4 µm and depths from 7.9±0.8 to 15.5±1.3 µm. Surface and contour characterization was carried out using X-ray diffraction analysis, scanning electron microscopy imaging and 3D-confocal profilometry. Cell activity and alignment on microchannels with different widths were determined after 1 and 3 days by photometric spectroscopy and fluorescence microscopic imaging and statistically analysed by Tukey's multiple comparison test. On days 1 and 3 for microchannels of width 16 and 30 µm, 70-80% of the osteoblasts oriented within an angular range of 0-15° relative to the microchannel direction. Interestingly, only 20% of the cells grew inside the microchannels for channel widths of 16 and 30 µm. Substrates with channel widths of 45, 65 and 76 µm allowed ∼40% of the cells to grow inside. The depth of the microchannel showed hardly any significant impact. All micropatterned surfaces provoked a good cell attachment, as flat and spread cell morphologies with lamellipodiae and filopodiae could already be observed after 1 day. The effect of the microchannels on osteoblast activity was determined using the colorimetric WST-1 assay. In addition, the cell differentiation was assessed by collagen type I staining. The cell activity obtained by WST-1 assay differed insignificantly for all micropatterned samples of various widths and depths. The assessment of collagen type I yielded the same amounts for all micropatterned samples after 1, 3 and 7 days. In summary, the microchannel width of HA-based patterns has a distinct effect on the directed growth of human osteoblast cells, allowing novel design strategies for surfaces such as dental implants.

Three-dimensional volumetric spatially angle-corrected pixelwise fetal flow volume measurement.

PURPOSE: Early attempts to calculate fetal global perfusion used 2 D images. The results were not sufficiently reliable. That's why RI measurements are still in use despite the fact that they do not reflect the amount of blood passing through the fetus. We present a novel three-dimensional approach to overcome these limitations. MATERIALS AND METHODS: In 124 singleton pregnancies between the 23rd and 4st gestational week, a three-dimensional color Doppler sonographic record of the umbilical cord was made, resulting in 281 volume data sets. With dedicated software (PixelFlux) the spatial angle of the umbilical vein was calculated and the true global fetal perfusion was calculated from its horizontal transection as the product of the area of all pixels and the spatial angle-corrected velocity. To validate the PixelFlux technique, phantom flow measurements were carried out. RESULTS: Phantom flow measurements revealed a highly significant correlation of actual flow volumes and those measured by the PixelFlux technique (p < 0.001; rPearson = 0.987 - 0.991) with an even higher interobserver correlation (p < 0.001; rPearson = 0.997). We found a significant correlation of fetal volume flow to gestational age and weight (r = 0.529 at spatial angles below 30° to r = 0.724 at spatial angles below 5°) and a significant influence of the spatial angle on this correlation (p = 0.003; r = -0.865). CONCLUSION: Spatial angle-corrected global fetal perfusion measurement improves existing approaches to fetal perfusion evaluation, and is feasible, simple and fast. Thus, it can be recommended to explore the relationship of fetal perfusion and disturbances of fetal development.

Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome.

OBJECTIVE: To evaluate efficacy and safety of clobazam, a 1,5-benzodiazepine, as adjunctive therapy for Lennox-Gastaut syndrome (LGS). METHODS: Patients aged 2-60 years were randomized to placebo or clobazam 0.25, 0.5, or 1.0 mg/kg/day. Study consisted of 4-week baseline, 3-week titration, and 12-week maintenance phases, followed by a 2- or 3-week taper or continuation in an open-label extension. Primary endpoint was percentage decrease in mean weekly drop seizure rates during maintenance vs baseline phases for modified intention-to-treat (mITT) population. Secondary outcomes included other seizure types, responder rates, and physicians' and caregivers' global assessments. RESULTS: A total of 305 patients were screened, 238 were randomized, and 217 composed the mITT population. Of patients enrolled after a protocol amendment, 125/157 (79.6%) completed. Average weekly drop seizure rates decreased 12.1% for placebo vs 41.2% (p = 0.0120), 49.4% (p = 0.0015), and 68.3% (p < 0.0001) for the clobazam 0.25-, 0.5-, and 1.0-mg/kg/day groups. Responder rates (≥50%) were 31.6% (placebo) vs 43.4% (p = 0.3383), 58.6% (p = 0.0159), and 77.6% (p < 0.0001) for clobazam 0.25-, 0.5-, and 1.0-mg/kg/day groups. Physicians' and caregivers' assessments indicated clobazam significantly improved symptoms. Somnolence, pyrexia, upper respiratory infections, and lethargy were the most frequent adverse events reported for clobazam. CONCLUSIONS: Clobazam significantly decreased weekly drop seizure rates in LGS. No new safety signals were identified. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that clobazam as adjunctive therapy is efficacious, in a dosage-dependent manner, in reducing mean weekly drop seizure rates of patients with LGS over 12 weeks.

Evaluation of the pharmacokinetics and pharmacodynamics of intravenous lansoprazole.

AIM: To compare the pharmacokinetics and pharmacodynamics of lansoprazole 30 mg administered intravenously in 0.9% NaCl or in polyethylene glycol, or orally. METHODS: Twenty-nine subjects received lansoprazole orally on days 1-7 and intravenous lansoprazole in NaCl on days 8-14. Blood samples were collected on days 1, 7, 8 and 14. Fasting basal acid output and pentagastrin-stimulated maximal acid output were determined on days -1, 8, 9 and 15. Thirty-six different subjects received one of four regimen sequences: intravenous lansoprazole in NaCl, intravenous in polyethylene glycol, per orally, or intravenous placebo, each for 5 days. Twenty-four hour intragastric pH was recorded on days 1 and 5. RESULTS: Intravenous and per oral lansoprazole for 7 days produced equivalent basal acid output and maximal acid output suppression. Pharmacokinetics and mean pH values with intravenous lansoprazole in NaCl or polyethylene glycol were equivalent. Both produced mean pH and percentages of time pH above 3, 4, 5 and 6 that were significantly greater than did per orally. CONCLUSIONS: Intravenous lansoprazole inhibits acid secretion as effectively in NaCl as in polyethylene glycol, and its onset of action is faster than per oral lansoprazole.