Summary Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0.83, 95% CI 0.63–1.09; p=0.18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1.91, 1.06–3.44; p=0.0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0.82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0.41) and sepsis (seven [1%] vs six [1%]; p=0.79). Interpretation In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws. Funding National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians’ Services Incorporated.
Background The Radiographic Union Score for Hip (RUSH) is a previously validated outcome instrument designed to improve intra-and interobserver reliability when describing the radiographic healing of femoral neck fractures. The ability to identify fractures that have not healed is important for defining nonunion in clinical trials and predicting patients who will likely require additional surgery to promote fracture healing. We sought to investigate the utility of the RUSH score to define femoral neck fracture nonunion. Questions/purposes (1) What RUSH score threshold yields at least 98% specificity to diagnose nonunion at 6 months postinjury? (2) Using the threshold identified, are patients below this threshold at greater risk of reoperation for nonunion and for other indications? Methods A representative sample of 250 out of a cohort of 725 patients with adequate 6-month hip radiographs was analyzed from a multinational elderly hip fracture trial (FAITH). All patients had a femoral neck fracture and were treated with either multiple cancellous screws or a sliding hip screw. Two reviewers independently determined the RUSH score based on the 6-month postinjury radiographs and interrater reliability was assessed with the interclass correlation coefficient (ICC). There was substantial reliability between the reviewers assigning the RUSH scores (ICC, 0.81; 95% confidence interval [CI], 0.76-0.85). The RUSH score is a checklist-based system that quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance.. Fracture healing was determined by two independent methods: (1) concurrently by the treating surgeon using both clinical and radiographic assessments as per routine clinical care; and (2) retrospectively by a Central Adjudication Committee using complete obliteration of the fracture line on radiographs alone. Receiver operating characteristic tables were used to 123Clin Orthop Relat Res (2016) 474:1396-1404 DOI 10.1007 Clinical Orthopaedics and Related Research ® A Publication of The Association of Bone and Joint Surgeons® define a RUSH threshold score that was [ 98% specific for fracture nonunion. Results A threshold score of \ 18 was associated with a 100% specificity (95% CI, 97%-100%) and a positive predictive value of 100% (95% CI, 73%-100%) for radiographic nonunion. In contrast, using the fracture healing assessments of the treating surgeons failed to identify a useful discriminatory nonunion threshold and the highest positive predictive value was 43%. With respect to complications, patients with RUSH scores below 18 had greater risk of undergoing reoperation for nonunion ( Conclusions The 6-month RUSH score is a reliable method for assessing radiographic healing. Our results highlight the discordance between radiographic determinations and clinician assessments of fracture healing and stress the need for clinical data to be incorporated in research studies evaluating fracture healing. Level of Evidence Le...
The use of skin allografts to temporarily replace lost or damaged skin is practiced worldwide. Naturally occurring contamination can be present on skin or can be introduced at recovery or during processing. This contamination can pose a threat to allograft recipients. Bacterial culture and disinfection of allografts are mandated, but the specific practices and methodologies are not dictated by standards. A systematic review of literature from three databases found 12 research articles that evaluated bioburden reduction processes of skin grafts. The use of broad spectrum antibiotics and antifungal agents was the most frequently identified disinfection method reported demonstrating reductions in contamination rates. It was determined that the greatest reduction in the skin allograft contamination rates utilized 0.1 % peracetic acid or 25 kGy of gamma irradiation at lower temperatures.Electronic supplementary materialThe online version of this article (doi:10.1007/s10561-016-9569-2) contains supplementary material, which is available to authorized users.
Introduction Growing interest in the medicinal properties of cannabis has led to an increase in its use to treat medical conditions, and the establishment of state-specific medical cannabis programs. Despite medical cannabis being legal in 33 states and the District of Colombia, there remains a paucity of data characterizing the patients accessing medical cannabis programs. Methods We retrospectively reviewed a registry with data from 33 medical cannabis evaluation clinics in the United States, owned and operated by CB2 Insights. Data were collected primarily by face-to-face interviews for patients seeking medical cannabis certification between November 18, 2018 and March 18, 2020. Patients were removed from the analysis if they did not have a valid date of birth, were less than 18, or did not have a primary medical condition reported; a total of 61,379 patients were included in the analysis. Data were summarized using descriptive statistics expressed as a mean (standard deviation (SD)) or median (interquartile range (IQR)) as appropriate for continuous variables, and number (percent) for categorical variables. Statistical tests performed across groups included t-tests, chi-squared tests and regression. Results The average age of patients was 45.5, 54.8% were male and the majority were Caucasian (87.5%). Female patients were significantly older than males (47.0 compared to 44.6). Most patients reported cannabis experience prior to seeking medical certification (66.9%). The top three mutually exclusive primary medical conditions reported were unspecified chronic pain (38.8%), anxiety (13.5%) and post-traumatic stress disorder (PTSD) (8.4%). The average number of comorbid conditions reported was 2.7, of which anxiety was the most common (28.3%). Females reported significantly more comorbid conditions than males (3.1 compared to 2.3). Conclusion This retrospective study highlighted the range and number of conditions for which patients in the US seek medical cannabis. Rigorous clinical trials investigating the use of medical cannabis to treat pain conditions, anxiety, insomnia, depression and PTSD would benefit a large number of patients, many of whom use medical cannabis to treat multiple conditions.
Cardiovascular allografts are usually disinfected using antibiotics, but protocols vary significantly between tissue banks. It is likely that different disinfection protocols will not have the same level of efficacy; they may also have varying effects on the structural integrity of the tissue, which could lead to significant differences in terms of clinical outcome in recipients. Ideally, a disinfection protocol should achieve the greatest bioburden reduction with the lowest possible impact on tissue integrity. We conducted a systematic review of methods applied to disinfect cardiovascular tissues. The use of multiple broad spectrum antibiotics in conjunction with an antifungal agent resulted in the greatest reduction in bioburden. Antibiotic incubation periods were limited to less than 24 h, and most protocols incubated tissues at 4 °C, however one study demonstrated a greater reduction of microbial load at 37 °C. None of the reviewed studies looked at the impact of these disinfection protocols on the risk of infection or any other clinical outcome in recipients.Electronic supplementary materialThe online version of this article (doi:10.1007/s10561-016-9570-9) contains supplementary material, which is available to authorized users.
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