NCT01401166.

After obtaining informed consent, 80 patients were randomised to undergo a navigated or conventional total knee replacement. All received a cemented, unconstrained, cruciate-retaining implant with a rotating platform. Full-length standing and lateral radiographs and CT scans of the hip, knee and ankle joint were carried out five to seven days after operation. No notable differences were found between computer-assisted navigation and conventional implantation techniques as regards the rotational alignment of the femoral or tibial components. Although the deviation from the transepicondylar axis was relatively low, there was a considerable range of deviation for the tibial rotational alignment. There was no statistically significant difference regarding the occurrence pattern of outliers in mechanical malalignment but the number of outliers was reduced in the navigated group.

PurposeTotal knee arthroplasty (TKA) is an effective, but also cost-intensive health care procedure for the elderly. Furthermore, bearing demographic changes in Western Europe in mind, TKA-associated financial investment for health care insurers will increase notably and thereby catalyze discussions on ressource allocation to Orthopedic surgery. To derive a quantitative rationale for such discussions within Western Europe's health care systems, a prospective assessment of both the benefit of TKA from a patient's perspective as well as its cost effectiveness from a health care insurer's perspective was implemented.MethodsA prospective cost effectiveness trial recruited a total of 65 patients (60% females), who underwent TKA in 2006; median age of patients was 66 years (interquartile range 61 - 74 years). Before and three months after surgery patients were interviewed by means of the EuroQol-5D and the WOMAC questionnaires to assess their individual benefit due to TKA and the subsequent inpatient rehabilitation. Both questionnaires' benefit estimates were transformed into the number of gained quality adjusted life years [QALYs]. Total direct cost estimates for the overall care were based on German DRG and rehabilitation cost rates [€]. The primary clinical endpoint of the investigation was the individual number of QALYs gained by TKA based on the WOMAC interview; the primary health economic endpoint was the marginal cost effectiveness ratio (MCER) relating the costs to the associated gain in quality of life [€/QALY].ResultsTotal direct costs for the overall procedure were estimed 9549 € in median. The WOMAC based interview revealed an overall gain of 4.59 QALYs (interquartile range 2.39 - 6.21 QALYs), resulting in marginal costs of 1795 €/QALY (1488 - 3288 €/QALY). The corresponding EuroQol based estimates were 2.93 QALYs (1.75 - 5.59 QALYs) and 3063 €/QALY (1613 - 5291 €/QALY). Logistic regression modelling identified the patients' age as the primary determinant of cost effectiveness (Likelihood Ratio p = 0.006): patients younger than 60 years showed a median gain of 6.45 QALYs and median marginal costs of 1463 €/QALY, patients between 60 - 70 years 5.47 QALYs and 1744 €/QALY, patients older than 70 years 2.76 QALYs and 3186 €/QALY.ConclusionTKA was proven to be cost effective from a health care insurer's perspective, although its marginal costs notably increased with increasing age. Note, however, that this age-related gradient in marginal cost effectiveness is of comparable order as the changes in cost effectiveness due to variation of the underlying assessment instrument.

Background. Breast cancer patients often use complementary and alternative medicine, but few prospectively collected data on the topic are available specifically for postmenopausal breast cancer patients. A large prospective study was therefore conducted within a noninterventional study in order to identify the characteristics of patients interested in integrative medicine. Methods. The EvAluate-TM study is a prospective, multicenter noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor–positive primary breast cancer. Between 2008 and 2009, 5045 postmenopausal patients were enrolled at 339 certified breast centers in Germany. As part of the data collection process, patients were asked at the baseline about their interest in and information needs relating to integrative medicine. Results. Of the 5045 patients recruited, 3411 responded to the questionnaire on integrative medicine and took part in the analysis, 1583 patients expressed an interest in integrative medicine, and 1828 patients declared no interest. Relevant predictors of interest in integrative medicine were age, body mass index, tumor size, previous chemotherapy, and use of concomitant medications for other medical conditions. Interest in integrative medicine declined highly significantly (P < .001) with age (<50 years, 74.1%; 50-60 years, 54.1%; >65 years, 38.0%). Patients in favor of integrative medicine were significantly less satisfied with the information received about individual treatments and antihormonal therapy. Patients with interest in integrative medicine were more often interested in rehabilitation and fitness, nutritional counseling, and additional support from self-help organizations. These women were mostly interested in receiving information about their disease and integrative medicine from a physician, rather than from other sources. Conclusions. This study shows that a considerable proportion of postmenopausal breast cancer patients are interested in integrative medicine. Information about integrative medicine should therefore be provided as part of patient care for this group. It was found that receiving concomitant medication for other medical conditions is one of the main predictors for women not being interested in integrative medicine. This group of patients may need special attention and individualized information about integrative medicine. Additionally, most patients were interested in obtaining the relevant information from their doctor.

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