Are large clinical trials in orthopaedic trauma justified?

© 2018 The Author(s). Background: The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. Methods: The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. Results: The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75-3.04; RR: 1.39, 95% CI: 0.60-3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81-1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50-1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04-1.57). Conclusions: Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. Trial registration: NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008

Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials

An amendment to this paper has been published and can be accessed via the original article

Operative Reduction and Fixation of a Sternomanubrial Dislocation: A Case Report and Literature Review

A dislocation of the sternomanubrial joint is a rare injury with varied treatment methods including both nonoperative and operative described methods. There is a paucity of literature regarding the optimal method of treatment as well as a lack of consensus on the best surgical construct. This case demonstrates the successful use of dual locking plate fixation for an acute type II sternomanubrial dislocation in a 22-year-old man. In principle, locking plate fixation affords greater unicortical fixation than traditional nonlocking fixation, and allows for minimising the risk of damage to pulmonary tree structures. The patient achieved good pain relief and regained physical function

Biochemical Measurement of Muscle Injury Created by Lumbar Surgery

Purposes: 1. To determine whether lumbar disc surgery (LS) provides a sufficiently detectable rise in serum creatine kinase (CK) concentration to serve as a model to study biochemical measurement of muscle injury, and 2. To use the model to examine the consistency of the time course of CK concentration changes. Method: The study used a repeated measures design. Six women and six men scheduled for LS were recruited. Blood samples were taken in the pre-operative waiting areas, immediately after surgery, at 6 hour intervals until discharge, and at 2, 4, and 6 to 7 days following surgery. Total serum CK was quantified using the Roche Modular to detect enzyme concentration. Results: Following LS, mean Total CK increased from a baseline 50 U/L (SD = 53) to a peak 114 U/L (SD = 32) in women (P < 0.001) and from 183 U/L (SD = 69) to a peak 454 U/L (SD = 173) in men (P < 0.05). Baseline to peak changes in CK exceeded subjects&#8217; own baseline fluctuations in all 6 women and all 6 men, and amounted to a mean 6 fold (SD = 4) increase in women and 16 fold (SD = 31) increase in men. While CK concentrations returned to baseline over the observation period in all subjects, time to peak ranged between 9 to 47 hours. Conclusions: The LS model produced a consistently detectable CK response in both genders. Time to peak is variable indicating a need for multiple serial measures to capture this biochemical injury response

Additional file 1: of Patient perceptions regarding physician reimbursements, wait times, and out-of-pocket payments for anterior cruciate ligament reconstruction in Ontario

Survey – Patient Perceptions Surrounding Anterior 441 Cruciate Ligament Reconstruction. (DOCX 13 kb

Wound surface area as a risk factor for flap complications among patients with open fractures

Copyright © 2018 by the American Society of Plastic Surgeons. Background: Soft-tissue complications often dictate the success of limb salvage and the overall outcome of open fractures. Based on prior work at the R Adams Cowley Shock Trauma Center, the authors hypothesize that wounds larger than 200 cm2 are associated with a greater likelihood of both flap-related reoperation and wound complications among patients requiring soft-tissue reconstruction with a rotational flap or free tissue transfer. Methods: This study was a secondary analysis of Fluid Lavage in Open Wounds trial data that included all patients who received a rotational or free tissue flap transfer for an open fracture. The primary outcome was flap-related reoperation within 12 months of injury. The secondary outcome was wound complication, which included events treated operatively or nonoperatively. Multivariable logistic regression was used to assess the association between wound size and outcomes, adjusting for confounders. Results: Seventeen percent of the 112 patients required a flap-related reoperation. A wound size greater than 200 cm2 was not associated with reoperation in an unadjusted model (p = 0.64) or adjusting for Gustilo type (p = 0.70). The sample had an overall wound complication rate of 47.3 percent. Patients with a wound size of greater than 200 cm2 were three times more likely to experience wound complications (OR, 3.05; 95 percent CI, 1.08 to 8.62; p = 0.04) when adjusting for moderate to severe wound contamination and wound closure in the operating room. Conclusion: The findings of this study demonstrate that wound surface area is an integral determinant for wound complication following soft-tissue flap treatment, but found no association between wound surface area and flap-related reoperation rates

Expression of the zinc finger transcription factor zDC (Zbtb46, Btbd4) defines the classical dendritic cell lineage

Classical dendritic cells (cDCs), monocytes, and plasmacytoid DCs (pDCs) arise from a common bone marrow precursor (macrophage and DC progenitors [MDPs]) and express many of the same surface markers, including CD11c. We describe a previously uncharacterized zinc finger transcription factor, zDC (Zbtb46, Btbd4), which is specifically expressed by cDCs and committed cDC precursors but not by monocytes, pDCs, or other immune cell populations. We inserted diphtheria toxin (DT) receptor (DTR) cDNA into the 3′ UTR of the zDC locus to serve as an indicator of zDC expression and as a means to specifically deplete cDCs. Mice bearing this knockin express DTR in cDCs but not other immune cell populations, and DT injection into zDC-DTR bone marrow chimeras results in cDC depletion. In contrast to previously characterized CD11c-DTR mice, non-cDCs, including pDCs, monocytes, macrophages, and NK cells, were spared after DT injection in zDC-DTR mice. We compared immune responses to Toxoplasma gondii and MO4 melanoma in DT-treated zDC- and CD11c-DTR mice and found that immunity was only partially impaired in zDC-DTR mice. Our results indicate that CD11c-expressing non-cDCs make significant contributions to initiating immunity to parasites and tumors