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  • 1
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    Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Exploratory Health-Related Quality of Life and Patient-Reported Functional Outcomes of a Multi-Centre 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients
    Elsevier BV ; 2021
    In:  Injury Vol. 52, No. 10 ( 2021-10), p. 3051-3059
    Details
    In: Injury, Elsevier BV, Vol. 52, No. 10 ( 2021-10), p. 3051-3059
    Type of Medium: Online Resource
    ISSN: 0020-1383
    URL: Article
    DOI: 10.1016/j.injury.2021.02.030
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
    detail.hit.zdb_id: 2011808-9
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  • 2
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    What Predicts Health-Related Quality of Life for Patients With Displaced Femoral Neck Fractures Managed With Arthroplasty? A Secondary Analysis of the HEALTH Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Journal of Orthopaedic Trauma Vol. 34, No. 3 ( 2020-11), p. S29-S36
    Details
    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
    URL: Article
    DOI: 10.1097/BOT.0000000000001933
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 2041334-8
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  • 3
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    Timing and Management of Surgical Site Infections in Patients With Open Fracture Wounds: A Fluid Lavage of Open Wounds Cohort Secondary Analysis
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Journal of Orthopaedic Trauma Vol. 35, No. 3 ( 2021-03), p. 128-135
    Details
    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
    URL: Article
    DOI: 10.1097/BOT.0000000000001912
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 2041334-8
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  • 4
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    The effect of time to irrigation and debridement on the rate of reoperation in open fractures : a propensity score-based analysis of the Fluid Lavage of Open Wounds (FLOW) study
    British Editorial Society of Bone & Joint Surgery ; 2021
    In:  The Bone & Joint Journal Vol. 103-B, No. 6 ( 2021-06-01), p. 1055-1062
    Details
    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
    URL: Article
    DOI: 10.1302/0301-620X.103B6.BJJ-2020-2289.R1
    Language: English
    Publisher: British Editorial Society of Bone & Joint Surgery
    Publication Date: 2021
    detail.hit.zdb_id: 2697480-0
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  • 5
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    A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan
    Springer Science and Business Media LLC ; 2022
    In:  Trials Vol. 23, No. 1 ( 2022-09-12)
    Details
    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
    URL: Article
    DOI: 10.1186/s13063-022-06541-0
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2040523-6
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  • 6
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    Prevalence and Perception of Intimate Partner Violence-Related Traumatic Brain Injury
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Journal of Head Trauma Rehabilitation Vol. 37, No. 1 ( 2022-01), p. 53-61
    Details
    In: Journal of Head Trauma Rehabilitation, Ovid Technologies (Wolters Kluwer Health), Vol. 37, No. 1 ( 2022-01), p. 53-61
    Abstract: Traumatic brain injury (TBI) is a serious and often undiagnosed consequence of intimate partner violence (IPV). Data on prevalence of TBI among IPV survivors are emerging, but prevalence of IPV among patients presenting to TBI clinics is unknown. Identification of IPV is important to ensure patients with TBI receive appropriate intervention and referrals. Objective: To determine the proportion of women 18 years and older presenting to an acquired brain injury (ABI) clinic with confirmed or suspected concussion who reported experiencing IPV in the last 12 months or their lifetime. Methods: Single-center cross-sectional cohort study. Proportion of IPV-related TBI or head, neck, or facial) injuries were determined using a modified HELPS Brain Injury Screening Tool and the Neurobehavioral Symptom Inventory. Results: Of the 97 women approached, 50 were enrolled in the study. The average age was 46.1 years and 32 women (64.0%) reported a relationship history with a violent partner; 12-month prevalence of IPV was 26.5% and lifetime prevalence was 44.0%. Within their lifetime, all (44.0%) who reported an IPV history reported emotional abuse, 24.0% reported physical abuse, and 18.0% sexual abuse. HELPS responses indicated a high potential of lifetime IPV-related TBI for 29.2%, most commonly from being hit in the face or head (20.8%). Conclusion: Implementation of IPV screening in community-based ABI clinics is a pivotal step toward understanding the potential scope of TBI and addressing the wide range of somatic, cognitive, and affective symptoms experienced by IPV survivors. IPV screening also will lead to timely referral and follow-up and increase patient safety after discharge from rehabilitation.
    Type of Medium: Online Resource
    ISSN: 0885-9701
    URL: Article
    DOI: 10.1097/HTR.0000000000000749
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2053481-4
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  • 7
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    Effect of Tourniquet Use During Surgical Treatment of Open Fractures
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Journal of Bone and Joint Surgery Vol. 103, No. 10 ( 2021-5-19), p. 860-868
    Details
    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
    URL: Article
    DOI: 10.2106/JBJS.20.01458
    RVK:
    XA 52200.A
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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  • 8
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    Does negative pressure wound therapy reduce the odds of infection and improve health-related quality of life in patients with open fractures?
    British Editorial Society of Bone & Joint Surgery ; 2022
    In:  Bone & Joint Open Vol. 3, No. 3 ( 2022-03-01), p. 189-195
    Details
    In: Bone & Joint Open, British Editorial Society of Bone & Joint Surgery, Vol. 3, No. 3 ( 2022-03-01), p. 189-195
    Abstract: To evaluate the impact of negative pressure wound therapy (NPWT) on the odds of having deep infections and health-related quality of life (HRQoL) following open fractures. Methods Patients from the Fluid Lavage in Open Fracture Wounds (FLOW) trial with Gustilo-Anderson grade II or III open fractures within the lower limb were included in this secondary analysis. Using mixed effects logistic regression, we assessed the impact of NPWT on deep wound infection requiring surgical intervention within 12 months post-injury. Using multilevel model analyses, we evaluated the impact of NPWT on the Physical Component Summary (PCS) of the 12-Item Short-Form Health Survey (SF-12) at 12 months post-injury. Results After applying inverse probability treatment weighting to adjust for the influence of injury characteristics on type of dressing used, 1,322 participants were assessed. The odds of developing a deep infection requiring operative management within 12 months of initial surgery was 4.52-times higher in patients who received NPWT compared to those who received a standard wound dressing (95% confidence interval (CI) 1.84 to 11.12; p = 0.001). Overall, 1,040 participants were included in our HRQoL analysis, and those treated with NPWT had statistically significantly lower mean SF-12 PCS post-fracture (p 〈 0.001). These differences did not reach the minimally important difference for the SF-12 PCS. Conclusion Our analysis found that patients treated with NPWT had higher odds of developing a deep infection requiring operative management within 12 months post-fracture. Due to possible residual confounding with the worst cases being treated with NPWT, we are unable to determine if NPWT has a negative effect or is simply a marker of worse injuries or poor access to early soft-tissue coverage. Regardless, our results suggest that the use of this treatment requires further evaluation. Cite this article: Bone Jt Open 2022;3(3):189–195.
    Type of Medium: Online Resource
    ISSN: 2633-1462
    URL: Article
    DOI: 10.1302/2633-1462.33.BJO-2021-0199.R1
    Language: English
    Publisher: British Editorial Society of Bone & Joint Surgery
    Publication Date: 2022
    detail.hit.zdb_id: 3016366-3
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  • 9
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    Development of machine-learning algorithms for 90-day and one-year mortality prediction in the elderly with femoral neck fractures based on the HEALTH and FAITH trials
    British Editorial Society of Bone & Joint Surgery ; 2023
    In:  Bone & Joint Open Vol. 4, No. 3 ( 2023-3-14), p. 168-181
    Details
    In: Bone & Joint Open, British Editorial Society of Bone & Joint Surgery, Vol. 4, No. 3 ( 2023-3-14), p. 168-181
    Abstract: To develop prediction models using machine-learning (ML) algorithms for 90-day and one-year mortality prediction in femoral neck fracture (FNF) patients aged 50 years or older based on the Hip fracture Evaluation with Alternatives of Total Hip arthroplasty versus Hemiarthroplasty (HEALTH) and Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trials. Methods This study included 2,388 patients from the HEALTH and FAITH trials, with 90-day and one-year mortality proportions of 3.0% (71/2,388) and 6.4% (153/2,388), respectively. The mean age was 75.9 years (SD 10.8) and 65.9% of patients (1,574/2,388) were female. The algorithms included patient and injury characteristics. Six algorithms were developed, internally validated and evaluated across discrimination (c-statistic; discriminative ability between those with risk of mortality and those without), calibration (observed outcome compared to the predicted probability), and the Brier score (composite of discrimination and calibration). Results The developed algorithms distinguished between patients at high and low risk for 90-day and one-year mortality. The penalized logistic regression algorithm had the best performance metrics for both 90-day (c-statistic 0.80, calibration slope 0.95, calibration intercept -0.06, and Brier score 0.039) and one-year (c-statistic 0.76, calibration slope 0.86, calibration intercept -0.20, and Brier score 0.074) mortality prediction in the hold-out set. Conclusion Using high-quality data, the ML-based prediction models accurately predicted 90-day and one-year mortality in patients aged 50 years or older with a FNF. The final models must be externally validated to assess generalizability to other populations, and prospectively evaluated in the process of shared decision-making. Cite this article: Bone Jt Open  2023;4(3):168–181.
    Type of Medium: Online Resource
    ISSN: 2633-1462
    URL: Article
    DOI: 10.1302/2633-1462.43.BJO-2022-0162.R1
    Language: English
    Publisher: British Editorial Society of Bone & Joint Surgery
    Publication Date: 2023
    detail.hit.zdb_id: 3016366-3
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  • 10
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    Who, if anyone, may benefit from a total hip arthroplasty after a displaced femoral neck fracture? : a post hoc subgroup analysis of the HEALTH trial
    British Editorial Society of Bone & Joint Surgery ; 2022
    In:  Bone & Joint Open Vol. 3, No. 8 ( 2022-08-01), p. 611-617
    Details
    In: Bone & Joint Open, British Editorial Society of Bone & Joint Surgery, Vol. 3, No. 8 ( 2022-08-01), p. 611-617
    Abstract: The aim of this study was to explore the functional results in a fitter subgroup of participants in the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial to determine whether there was an advantage of total hip arthroplasty (THA) versus hemiarthroplasty (HA) in this population. Methods We performed a post hoc exploratory analysis of a fitter cohort of patients from the HEALTH trial. Participants were aged over 50 years and had sustained a low-energy displaced femoral neck fracture (FNF). The fittest participant cohort was defined as participants aged 70 years or younger, classified as American Society of Anesthesiologists grade I or II, independent walkers prior to fracture, and living at home prior to fracture. Multilevel models were used to estimate the effect of THA versus HA on functional outcomes. In addition, a sensitivity analysis of the definition of the fittest participant cohort was performed. Results There were 143 patients included in the fittest cohort. Mean age was 66 years (SD 4.5) and 103 were female (72%). No clinically relevant differences were found between the treatment groups in the primary and sensitivity analyses. Conclusion This analysis found no differences in functional outcomes between HA and THA within two years of displaced low-energy FNF in a subgroup analysis of the fittest HEALTH patients. These findings suggest that very few patients above 50 years of age benefit in a clinically meaningful way from a THA versus a HA early after injury. Cite this article: Bone Jt Open 2022;3(8):611–617.
    Type of Medium: Online Resource
    ISSN: 2633-1462
    URL: Article
    DOI: 10.1302/2633-1462.38.BJO-2022-0074.R1
    Language: English
    Publisher: British Editorial Society of Bone & Joint Surgery
    Publication Date: 2022
    detail.hit.zdb_id: 3016366-3
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