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  • 1
  • 2
    In: Journal of Orthopaedic Trauma, Ovid Technologies (Wolters Kluwer Health), Vol. 34, No. 3 ( 2020-11), p. S37-S41
    Abstract: Displaced femoral neck fractures are a significant source of morbidity and mortality and can be treated with either hemiarthroplasty (HA) or total hip arthroplasty (THA). Proponents of THA have argued THA offers lower risk of revision, with improved functional outcomes when compared to HA. To evaluate cost effectiveness of THA compared with HA, a trial-based economic analysis of the HEALTH study was undertaken. Methods: Health care resource utilization (HRU) and health-related quality of life (HRQoL) data were collected postoperatively and costed using publicly available databases. Using EuroQol-5 Dimensions (EQ-5D) scores, we derived quality adjusted life years (QALYs). A 1.5% discount rate to both costs and QALYs was applied. Age analyses per age group were conducted. All costs are reported in 2019 Canadian dollars. Results: When compared with HA, THA was not cost-effective for all patients with displaced femoral neck fractures ($150,000/QALY gained). If decision makers were willing to spend $50,000 or $100,000 to gain one QALY, the probability of THA being cost-effective was 12.8% and 32.8%, respectively. In a subgroup of patients younger than 73 (first quartile), THA was both more effective and less costly. Otherwise, THA was more expensive and yielded marginal HRQoL gains. Conclusions: Our results suggest that for most patients, THA is not a cost-effective treatment for displaced femoral neck fracture management versus HA. However, THA may be cost effective for younger patients. These patients experience more meaningful improvements in quality of life with less associated cost because of shorter hospital stay and fewer postoperative complications. Level of Evidence: Economic Level II. See Instructions for Authors for a complete description of levels of evidence.
    Type of Medium: Online Resource
    ISSN: 0890-5339
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 639099-7
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  • 3
    In: Journal of Orthopaedic Trauma, Ovid Technologies (Wolters Kluwer Health), Vol. 32, No. 5 ( 2018-05), p. 223-230
    Abstract: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25–2.50; P = 0.001], higher body mass index (for every 5-point increase) (HR 1.19, 95% CI 1.02–1.39; P = 0.027), displaced fracture (HR 2.16, 95% CI 1.44–3.23; P 〈 0.001), unacceptable quality of implant placement (HR 2.70, 95% CI 1.59–4.55; P 〈 0.001), and smokers treated with cancellous screws versus smokers treated with a sliding hip screw (HR 2.94, 95% CI 1.35–6.25; P = 0.006). Additionally, for every 10-year decrease in age, participants experienced an average increased risk of 39% for hardware removal. Conclusions: Results of this study may inform future research by identifying high-risk patients who may be better treated with arthroplasty and may benefit from adjuncts to care (HR 1.39, 95% CI 1.05–1.85; P = 0.020). Level of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
    Type of Medium: Online Resource
    ISSN: 0890-5339
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
    detail.hit.zdb_id: 639099-7
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  • 4
    In: Journal of Orthopaedic Trauma, Ovid Technologies (Wolters Kluwer Health), Vol. 35, No. 3 ( 2021-03), p. 128-135
    Abstract: Many studies report on the incidence or prevalence of fracture-related surgical site infections (SSIs) after open fractures; however, few studies report on their timing and management outcomes. To address this gap, we used data from the Fluid Lavage of Open Wounds trial to determine timing of diagnosis, management, and resolution of SSIs. Methods: All participants included in this analysis had an SSI after an open fracture. Participants were assigned to a group based on the type of SSI as follows: (1) those who developed a superficial SSI and (2) those who had either a deep or organ/space SSI. Descriptive statistics characterized the type, timing, and management of each SSI. Results: Of the 2445 participants in the Fluid Lavage of Open Wounds trial, 325 (13.3%) had an SSI. Superficial SSIs were diagnosed significantly earlier [26.5 days, interquartile range (IQR) 12–48] than deep or organ/space SSIs (53 days, IQR 15–119). Of the 325 patients with SSIs, 174 required operative management and 151 were treated nonoperatively. For SSIs managed operatively, median time for infection resolution was 73 days (IQR 28–165), and on average, 1.73 surgeries (95% confidence interval 1.58–1.88) were needed during the 12 months follow-up. There were 24 cases whose SSIs were not resolved at the time of the final follow-up visit (12 months). Conclusions: Based on this study's findings and in contradistinction to the Centers for Disease Control and Prevention guidelines, after an open fracture, superficial SSIs were diagnosed at one month and deep/organ/space SSIs at 2 months. This information can allow for earlier infection detection. In addition, the knowledge that approximately 50% of the SSIs in our study required a reoperation and 3 months at a minimum to resolve will assist orthopaedic surgeons when counseling their patients. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
    Type of Medium: Online Resource
    ISSN: 0890-5339
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 639099-7
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  • 5
    In: Journal of Orthopaedic Trauma, Ovid Technologies (Wolters Kluwer Health), Vol. 35, No. 2 ( 2021-02), p. 92-99
    Abstract: To determine if cancellous screw (CS) and sliding hip screw (SHS) technical factors during low-energy femoral neck fracture fixation affects a 24-month revision surgery rate and health-related quality of life (HRQL). Design: Prospective randomized controlled study. Setting: International, multicenter. Patients: Eight hundred ninety-eight femoral neck fracture patients age 50 years and older. Intervention: Patients were randomized to fracture stabilization with either CSs or a SHS device as part of the Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH) trial. CS technical factors analyzed included screw diameter, short versus long screw threads, screw number and formation, screw orientation, and washer use. SHS technical factors studied were side plate length, supplemental screw use, lag screw position, and tip–apex distance. Main Outcome Measurements: Revision surgeries within 24 months to promote fracture healing, relieve pain, treat infection, or improve function. In addition, HRQL measures were collected, including the SF-12 Physical Component Score and Western Ontario and McMaster Universities Osteoarthritis Index. Results: The 3-screw inverted triangle pattern had a significantly lower revision surgery rate than a 3-screw triangle formation ( P = 0.004). No other CS or SHS technical factors were predictive of revision surgery or affected a patient's HRQL ( P 〉 0.05). Conclusions: A 3-screw inverted triangle pattern was superior to a 3-screw triangle formation. However, injury and patient factors such as fracture displacement, age, smoking status and sex play a more significant role in clinical outcomes for low-energy femoral neck fracture treatment. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
    Type of Medium: Online Resource
    ISSN: 0890-5339
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 639099-7
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  • 6
    In: Journal of Orthopaedic Trauma, Ovid Technologies (Wolters Kluwer Health), Vol. 34, No. 3 ( 2020-11), p. S29-S36
    Abstract: Total hip arthroplasty (THA) has been argued to improve health-related quality of life (HRQoL) and function in femoral neck fracture patients compared with hemiarthroplasty (HA). The HEALTH trial showed no clinically important functional advantages of THA over HA. The current analysis explores factors associated with HRQoL and function in this population. Methods: Using repeated measures regression, we estimated the association between HRQoL and function [Short Form-12 (SF-12) physical component score (PCS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score] and 23 variables. Results: THA as compared to monopolar HA, but not bipolar HA, was more likely to improve PCS scores (adjusted mean difference [AMD] 1.88 points, P = 0.02), whereas higher American Society of Anesthesiologists score (AMD −2.64, P 〈 0.01), preoperative use of an aid (AMD −2.66, P 〈 0.01), and partial weight-bearing status postoperatively (AMD −1.38, P = 0.04) demonstrated less improvement of PCS scores over time. THA improved WOMAC function scores over time compared with monopolar HA (but not bipolar HA) (AMD −2.40, P 〈 0.01), whereas higher American Society of Anesthesiologists classification (AMD 1.99, P = 0.01) and preoperative use of an aid (AMD 5.39, P 〈 0.01) were associated with lower WOMAC function scores. Preoperative treatment for depression was associated with lower functional scores (AMD 7.73, P 〈 0.01). Conclusion: Patients receiving THA are likely to receive small and clinically unimportant improvements in health utility and function compared with those receiving monopolar HA and little improvement compared with those receiving bipolar HA. Patient-specific characteristics seem to play a larger role in predicting functional improvement among femoral neck fracture patients. Level of Evidence: Prognostic Level II.
    Type of Medium: Online Resource
    ISSN: 0890-5339
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 639099-7
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  • 7
    Online Resource
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    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Journal of Bone and Joint Surgery Vol. 103, No. 10 ( 2021-5-19), p. 860-868
    In: Journal of Bone and Joint Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 103, No. 10 ( 2021-5-19), p. 860-868
    Abstract: This article was updated on September 24, 2021, because of a previous error. On page 864, in the final rowof Tables III and IV,text that had read “Gustilo Type IIIA and tourniquet use” now reads “Gustilo Type IIIB and tourniquet use.”. An erratum has been published: J Bone Joint Surg Am. 2021 November 3;103(21):e88. Background: We sought to evaluate whether tourniquet use, with the resultant ischemia and reperfusion, during surgical treatment of an open lower-extremity fracture was associated with an increased risk of complications. Methods: This is a retrospective cohort study of 1,351 patients who had an open lower-extremity fracture at or distal to the proximal aspect of the tibia and who participated in the FLOW (Fluid Lavage of Open Wounds) trial. The independent variable was intraoperative tourniquet use, and the primary outcome measures were adjudicated unplanned reoperation within 1 year of the injury and adjudicated nonoperative wound complications. Results: Unplanned reoperation and nonoperative wound complications were roughly even between the no-tourniquet (18.7% and 19.1%, respectively) and tourniquet groups (17.8% and 20.8%) (p = 0.78 and p = 0.52). Following matching, as determined by model interactions, tourniquet use was a significant predictor of unplanned reoperation in Gustilo Type-IIIA (odds ratio, 3.60; 95% confidence interval, 1.16 to 11.78) and IIIB fractures (odds ratio, 16.61; 95% confidence interval, 2.15 to 355.40). Conclusions: The present study showed that tourniquet use did not influence the likelihood of complications following surgical treatment of an open lower-extremity fracture. However, in cases of severe open fractures, tourniquet use was associated with increased odds of unplanned reoperation; surgeons should be cautious with regard to tourniquet use in this setting. Level of Evidence: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.
    Type of Medium: Online Resource
    ISSN: 0021-9355 , 1535-1386
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 220625-0
    detail.hit.zdb_id: 1473137-X
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  • 8
    In: Trials, Springer Science and Business Media LLC, Vol. 23, No. 1 ( 2022-09-12)
    Abstract: Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020. Methods and design The Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites. Results The primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention’s National Healthcare Safety Network reporting criteria (2017). All participants’ surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture. Conclusion This manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.
    Type of Medium: Online Resource
    ISSN: 1745-6215
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2040523-6
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  • 9
    In: The Bone & Joint Journal, British Editorial Society of Bone & Joint Surgery, Vol. 103-B, No. 6 ( 2021-06-01), p. 1055-1062
    Abstract: Despite long-standing dogma, a clear relationship between the timing of surgical irrigation and debridement (I & D) and the development of subsequent deep infection has not been established in the literature. Traditionally, I & D of an open fracture has been recommended within six hours of injury based on animal studies from the 1970s, however the clinical basis for this remains unclear. Using data from a multicentre randomized controlled trial of 2,447 open fracture patients, the primary objective of this secondary analysis is to determine if a relationship exists between timing of wound I & D (within six hours of injury vs beyond six hours) and subsequent reoperation rate for infection or healing complications within one year for patients with open limb fractures requiring surgical treatment. Methods To adjust for the influence of patient and injury characteristics on the timing of I & D, a propensity score was developed from the dataset. Propensity-adjusted regression allowed for a matched cohort analysis within the study population to determine if early irrigation put patients independently at risk for reoperation, while controlling for confounding factors. Results were reported as odds ratios (ORs), 95% confidence intervals (CIs), and p-values. All analyses were conducted using STATA 14. Results In total, 2,286 of 2,447 patients randomized to the trial from 41 orthopaedic trauma centres across five countries had complete data regarding time to I & D. Prior to matching, the patients managed with early I & D had a higher proportion requiring reoperation for infection or healing complications (17% vs 13%; p = 0.019), however this does not account for selection bias of more severe injuries preferentially being treated earlier. When accounting for propensity matching, early irrigation was not associated with reoperation (OR 0.71 (95% CI 0.47 to 1.07); p = 0.73). Conclusion When accounting for other variables, late irrigation does not independently increase risk of reoperation. Cite this article: Bone Joint J 2021;103-B(6):1055–1062.
    Type of Medium: Online Resource
    ISSN: 2049-4394 , 2049-4408
    Language: English
    Publisher: British Editorial Society of Bone & Joint Surgery
    Publication Date: 2021
    detail.hit.zdb_id: 2697156-2
    detail.hit.zdb_id: 2697480-0
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  • 10
    In: JAMA Surgery, American Medical Association (AMA), Vol. 157, No. 11 ( 2022-11-01), p. 983-
    Abstract: Unstable chest wall injuries have high rates of mortality and morbidity. In the last decade, multiple studies have reported improved outcomes with operative compared with nonoperative treatment. However, to date, an adequately powered, randomized clinical trial to support operative treatment has been lacking. Objective To compare outcomes of surgical treatment of acute unstable chest wall injuries with nonsurgical management. Design, Setting, and Participants This was a multicenter, prospective, randomized clinical trial conducted from October 10, 2011, to October 2, 2019, across 15 sites in Canada and the US. Inclusion criteria were patients between the ages of 16 to 85 years with displaced rib fractures with a flail chest or non–flail chest injuries with severe chest wall deformity. Exclusion criteria included patients with significant other injuries that would otherwise require prolonged mechanical ventilation, those medically unfit for surgery, or those who were randomly assigned to study groups after 72 hours of injury. Data were analyzed from March 20, 2019, to March 5, 2021. Interventions Patients were randomized 1:1 to receive operative treatment with plate and screws or nonoperative treatment. Main Outcomes and Measures The primary outcome was ventilator-free days (VFDs) in the first 28 days after injury. Secondary outcomes included mortality, length of hospital stay, intensive care unit stay, and rates of complications (pneumonia, ventilator-associated pneumonia, sepsis, tracheostomy). Results A total of 207 patients were included in the analysis (operative group: 108 patients [52.2%]; mean [SD] age, 52.9 [13.5] years; 81 male [75%] ; nonoperative group: 99 patients [47.8%]; mean [SD] age, 53.2 [14.3] years; 75 male [76%] ). Mean (SD) VFDs were 22.7 (7.5) days for the operative group and 20.6 (9.7) days for the nonoperative group (mean difference, 2.1 days; 95% CI, −0.3 to 4.5 days; P  = .09). Mortality was significantly higher in the nonoperative group (6 [6%]) than in the operative group (0%; P  = .01). Rates of complications and length of stay were similar between groups. Subgroup analysis of patients who were mechanically ventilated at the time of randomization demonstrated a mean difference of 2.8 (95% CI, 0.1-5.5) VFDs in favor of operative treatment. Conclusions and Relevance The findings of this randomized clinical trial suggest that operative treatment of patients with unstable chest wall injuries has modest benefit compared with nonoperative treatment. However, the potential advantage was primarily noted in the subgroup of patients who were ventilated at the time of randomization. No benefit to operative treatment was found in patients who were not ventilated. Trial Registration ClinicalTrials.gov Identifier: NCT01367951
    Type of Medium: Online Resource
    ISSN: 2168-6254
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2022
    detail.hit.zdb_id: 2701841-6
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