Aim Exercise therapy is a core element in the treatment of diabetes, but the benefits and harms for patients with a diabetic foot ulcer (DFU) are unknown. We therefore aimed to systematically review the benefits on health-related quality of life (HRQoL) and harms of exercise therapy for patients with DFU. Methods We searched 6 major databases. We performed citation and reference searches of included studies and contacted authors of ongoing trials. We included randomized controlled trials (RCTs) to assess potential benefits on HRQoL and harms of exercise therapy. Observational studies were included to identify potential harms of exercise therapy. Results We included 10 published publications of 9 trials and results from 2 unpublished trials including a total of 281 individuals with DFUs receiving various forms of exercise therapy. Due to lack of HRQoL measurements and high heterogeneity, it was not possible to perform meta-analyses. Results on HRQoL was present in one unpublished study. Harms reported ranged from musculoskeletal problems, increased wound size, to amputation; however, no safe conclusions could be drawn from the available data due to high heterogeneity and risk of bias in the trials. Conclusions/Interpretation Protective strategies are often preferred over therapeutic exercise that might have unforeseen consequences for patients over time. Based on the current literature, no evidence-based recommendations can be provided on the benefits and harms of exercise therapy for patients with DFUs. Well-conducted RCTs are needed to guide rehabilitation including detailed description of adverse events and an exercise program in a semisupervised or fully supervised setting.
Aims The aim of this study was to use national registry database information to estimate cumulative rates and relative risk of revision due to infection after reverse shoulder arthroplasty. Patients and Methods We included 17 730 primary shoulder arthroplasties recorded between 2004 and 2013 in The Nordic Arthroplasty Register Association (NARA) data set. With the Kaplan–Meier method, we illustrated the ten-year cumulative rates of revision due to infection and with the Cox regression model, we reported the hazard ratios as a measure of the relative risk of revision due to infection. Results In all, 188 revisions were reported due to infection during a mean follow-up of three years and nine months. The ten-year cumulative rate of revision due to infection was 1.4% overall, but 3.1% for reverse shoulder arthroplasties and 8.0% for reverse shoulder arthroplasties in men. Reverse shoulder arthroplasties were associated with an increased risk of revision due to infection also when adjusted for sex, age, primary diagnosis, and year of surgery (relative risk 2.41 (95% confidence interval 1.26 to 5.59); p = 0.001). Conclusion The overall incidence of revision due to infection was low. The increased risk in reverse shoulder arthroplasty must be borne in mind, especially when offering it to men. Cite this article: Bone Joint J 2019;101-B:702–707.
Chronic foot ulcers have extensive consequences for diabetic patients’ quality of life and increase risks of amputation and death. The aim of this trial was to assess the feasibility of conducting a larger clinical trial to evaluate the clinical effect of inforatio technique on healing of diabetic foot ulcers (DFUs). Inforatio technique is a novel minimal invasive procedure where small cuts are made on wound beds with punch biopsy tools. This study was a feasibility trial conducted at an outpatient wound care clinic at Zealand University Hospital. Twelve patients with DFUs were included. During a 90-day follow-up, participants visited the clinic 5 times and received inforatio technique twice. Feasibility was assessed with regard to recruitment, acceptability, burden, benefits, protocol adherence, and adverse events. The recruitment rate was 1 patient per eighth day (95% confidence interval [CI] = [4th-13th]), and the retention rate was 100% (95% CI = [74-100]). During follow-up, healing was observed for 4 ulcers (33%, 95% CI = [10-65]) with a mean time for healing of 59 days (range, 22-89) (95% CI = [5-113]). Five ulcers had a reduction of wound area and 3 ulcers had an increase in area from baseline to 90-day follow-up. No temporal relationship was found between inforatio application and wound area increase. There were no patient-reported harmful effects and no adverse events with probable relation to inforatio technique. Patient acceptability and participant adherence were promising. Thus, a larger clinical trial for evaluating the clinical effect of inforatio technique is considered feasible to conduct.
PurposeThe Western Ontario Osteoarthritis of the Shoulder (WOOS) index is a disease-specific, patient-reported, 19-question survey that measures the quality of life among patients with osteoarthritis (OA). The purpose of this study was to validate the Danish version of WOOS for OA and fractures (FRs) using modern test theory.Patients and methodsThe study included 1,987 arthroplasties in 1,943 patients that were reported to the Danish Shoulder Arthroplasty Register between 2006 and 2011. These included 847 OA and 1,140 FR cases.ResultsPrincipal component analysis indicated the unidimensionality of WOOS. The person reliabilities showed a floor-ceiling effect, indicating that a dichotomy was the best fit for the WOOS scale. For OA, WOOS showed good reliability (item and person reliability of 0.98 and 0.76) and good targeting, with a person mean of −0.56 logits. FR also showed good targeting (person mean of −0.08) and good reliability (item and person reliabilities of 1.00 and 0.86, respectively). All WOOS items fit well with the OA sample except items 5 and 6 (pertaining to grinding and the influence of weather). In addition, item 6 showed signs of degrading the scale with an outfit mean square of 2.46. Only item 6 showed a misfit for FR with no sign of scale degradation. The residual principal component analysis confirmed the unidimensionality of FR but not OA. Six items displayed clinically significant differential item functioning between OA and FR.ConclusionRasch analysis showed that WOOS had a good fit with the Rasch model when used as a dichotomous scale for OA and FR. However, the results were valid only when WOOS was divided into two categories with a threshold of 950 (50% of the maximum score). For the use of WOOS in future clinical research, we recommend that a dichotomous score be reported as a measure of clinical failure in OA and FR.
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