Cross-cultural adaptation and validation of the Oxford 12-item knee score in Japanese.

INTRODUCTION: With the high incidence of knee osteoarthritis (OA) in Japan, there is a strong need not only for surgical therapies, but also for validated outcome measures. For this study, we completed cross-cultural adaptation, testing and validation of the Oxford knee score (OKS) for prospective use in national and international clinical studies involving Japanese patients. MATERIALS AND METHODS: The Japanese version of the OKS was developed according to the standard cross-cultural adaptation guidelines. For validation, the OKS was tested on 54 patients diagnosed with OA, osteonecrosis, ligament or meniscus injury. Reliability was tested using the intraclass correlation coefficient (ICC). Internal consistency or homogeneity was assessed using Cronbach's alpha. The correlation between the Japanese OKS, WOMAC and SF-36 questionnaires was used to assess construct validity. RESULTS: No major difficulties were encountered with the translation and pre-testing stages. For reliability and validity, the Japanese OKS was completed without any missed responses by 53 (98.15%) and 52 (96.30%) patients at the first and second distribution, respectively. The total OKS showed good reliability with an ICC of 0.85. Internal consistency was strong (Cronbach's alpha = 0.90). Strong construct validity (ICC values of 0.51-0.84) was obtained against the WOMAC and SF-36 (physical functioning, role-physical, bodily pain, and social functioning subscales) scores. Notable "ceiling" effects of the OKS were reported for 11 of the 12 questionnaire items. CONCLUSION: The Japanese OKS has proven to be a reliable and valid instrument for the self-assessment of knee pain and function in Japanese speaking patients with knee OA and other knee complaints.

Complication reporting in orthopaedic trials. A systematic review of randomized controlled trials.

BACKGROUND: The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required for the development or improvement of orthopaedic care. The goal of this systematic review was to check whether essential data regarding the assessment of the prevalence, severity, and characteristics of complications related to orthopaedic interventions are consistently provided by the authors of papers on randomized controlled trials. METHODS: Five major peer-reviewed orthopaedic journals were screened for randomized controlled trials published between January 2006 and July 2007. All relevant papers were obtained, anonymized, and evaluated by two external reviewers. A checklist consisting of three main parts (definition, evaluation, and reporting) was developed and applied for the assessment of complication reporting. The results were stratified into surgical and nonsurgical categories. RESULTS: One hundred and twelve randomized controlled trials were identified. Although complications were included as trial outcomes in two-thirds of the studies, clear definitions of anticipated complications were provided in only eight trials. In 83% of the trials, the person or group assessing the complications was not identified. No trial involved a data safety review board for assessment and classification of complications. CONCLUSIONS: The lack of homogeneity among the published studies that we reviewed indicates that improvement in the reporting of complications in orthopaedic clinical trials is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and, most importantly, by clinical investigators.

Influence of osteoporosis on fracture fixation--a systematic literature review.

UNLABELLED: The goal of our systematic literature search was to prove whether the experimentally shown influence of osteoporosis on fracture fixation could be confirmed in clinical studies. Despite significant effects in several studies, this is not supported by pooled data due to lack of accurate osteoporosis assessment and complication definitions. INTRODUCTION: The fact that osteoporosis causes fractures is well-known; the assumption that it aggravates their orthopaedic treatment has not been proven. The goal of our systematic literature search was to find out whether the experimentally proven influence of osteoporosis on fracture fixation could be confirmed in clinical studies. METHODS: A systematic electronic database search was performed identifying articles that evaluated complications after fracture fixation among patients suspected of having osteoporosis as measured by BMD or surrogates including Singh index or risk factors. To determine complications risks (relative risk within 95% confidence interval) data were pooled across studies, weighted by sample size and stratified by treatment type. RESULTS: Ten studies out of 77 randomized controlled trials (51 hip, 23 distal radius and three proximal humerus studies) and three systematic reviews finally met eligibility criteria. Despite significant differences of the relative complication risk between osteoporotic and non-osteoporotic patients in several studies, this could not be proven in the pooled data. CONCLUSIONS: In contrast to biomechanical evidence that local osteoporosis affects anchorage of implants, this could not be reproduced in clinical studies, due to the lack of accurate osteoporosis assessment, missing complication definitions and heterogeneous inclusion criteria in these studies. Prospective studies are required that address specifically the correlation between local bone status and the risk of fixation failure.

[Treatment methods and outcomes of tibial shaft fractures in Switzerland. A prospective multicenter study of the Swiss AO]. / Behandlungsmethoden und -ergebnisse von Tibiaschaftfrakturen in der Schweiz. Eine prospektive multizentrische Studie der AO-Schweiz.

Fractures of the tibial shaft are very common and often associated with severe tissue damage. The aim of this study was to investigate the methods of treatment, the results and complications of tibial shaft fractures in Switzerland. In a prospective planned study the Swiss Association for the Study of Internal Fixation (AO) analyzed 585 tibial shaft fractures that were treated in 41 hospitals between 1st of July, 1994 and 30th of June, 1995. The cases were documented in the specific AO-documentation-forms, 78.3% (n = 458) of the cases received an effective follow-up. The most common type of accident were sports accidents with 41.5% (n = 243), followed by traffic accidents in 35.6% (n = 208). Conservative treatment was applied in 9.4% (n = 55). The most frequent used implant was the plate in 43.8% (n = 256), followed by the nail in 36.8% (n = 215) and by an external fixator in 9.5% (n = 56). In the group of patients treated with a nail 116 received an AO-Universal nail, 94 were treated with the solid tibial nail (UTN). 92.4% (n = 423) of the fractures healed with radiological alignment. 11.6% (n = 53) had a delayed or non-union. In this group 37.7% (n = 20) of patients sustained severe soft tissue damage, due to high-energy-trauma in 60% (n = 12). Of the patients with delayed or non-union one was treated primarily conservative, eight were treated with a plate, 24 with a nail and 20 with an external fixator primarily. The indications for fracture treatment with a plate or a nail was nearly the same in different fracture types. In summary, in Switzerland most tibial shaft fractures were treated with a plate or a nail with an equally good outcome.

[Functional fracture treatment of the upper arm]. / Funktionelle Knochenbruchbehandlung am Oberarm.

Using a functional brace, we treated 67 patients who had a fracture of the humeral shaft over a 5-year period from 1987 to 1992. We analysed several parameters of the fractures to discover those which influence healing. Desault, plaster cast or traction were used before applying a brace in an average time of 15 days. The osseous consolidation was 10 weeks in the average. The functional results were very good and good in 78.3%, acceptable in 18.3% and poor in 3.4% of the cases. Twelve humeral-shaft fractures were associated with a radial nerve palsy. Every patient recovered a full radial nerve function under the treatment with a functional brace. The retentive management of an operative treatment of humeral-shaft fractures associated with a nerve injury can be supported because of our experience.

[Quantitative evaluation of neurovegetative systemic changes based on the degree of minute-rhythmic coupling and control quality in acute and chronic diazépam therapy of neuroses]. / Quantitative Bewertung von neurovegetativen Systemveränderungen anhand des minutenrhythmischen Kopplungsgrades und der Regelgüte während akuter und chronischer Diazepamtherapie bei neurotischen Patienten

In 10 patients with definite forms of neurosis, controlphysiologic and biorhythmometric investigations were carried out to establish the effectiveness of diazepam therapy. After acute application of 10 mg diazepam, an increase in the degree of minute-rhythmic coupling correlated positively with a decrease of the control area, of the time adjustment of the heart rate after load-related deflection, and with an increase in a derived complex parameter of control quality. Chronic therapy with diazepam reversed the positive tendency of the biorhythmometric and control parameters. The results permit the conclusion that the minute-rhythmic coupling degree lends itself to diagnostic evaluation of the actual synchronization state or the related neurovegetative reaction state.