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Is arthroplaSty bEtter than interNal fixation for undiSplaced femoral nEck fracture? A national pragmatic RCT: the SENSE trial.

ABSTRACT: INTRODUCTION:Undisplaced femoral neck fractures (FNFs) are usually treated by internal fixation (IF) but two randomised controlled trials (RCTs) have demonstrated advantages of treatment with arthroplasty. The complication rate was lowered but there were no clinically improved patient-reported outcome measures (PROM), which could be due to underpowering or choice of selected PROM as the studies do appear to report a better functional outcome. We will conduct an RCT comparing IF with arthroplasties in patients aged over 65 years with an undisplaced FNF. METHODS AND ANALYSIS:All hospitals in Denmark treating patients with hip fracture can provide patients for this study; therefore, the study can be considered a national RCT. Patients over 65 years old with an undisplaced FNF will be screened for eligibility and patients will only be excluded if they are unable to understand the study information (due to dementia or language), if they have a posterior tilt >20°, a pathological fracture or they cannot walk. Participants will be electronically randomised (in alternating blocks of 4 or 6) into either IF or arthroplasty. Postoperative care will follow the department standards.Primary and secondary outcomes and measuring points have been established in collaboration with patients with hip fracture by focus group interviews. The primary outcome measure is the New Mobility Score assessed after 1?year. Secondary outcomes are the Oxford Hip Score, EuroQol 5 domain (EQ-5D-5L), degree of posterior tilt, pain Verbal Rating Scale, reoperation and mortality. ETHICS AND DISSEMINATION:The study is approved by the Danish Data Protection Agency (19/7429) and the scientific ethics committee (S-20180036). All participants will sign an informed consent before entering the trial. Because this is a national trial, all relevant healthcare professionals in Denmark will automatically receive the trial results that will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Registry (NCT04075461).

SUBMITTER: Viberg B

PROVIDER: S-EPMC7552868 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Is arthroplaSty bEtter than interNal fixation for undiSplaced femoral nEck fracture? A national pragmatic RCT: the SENSE trial.

Viberg Bjarke B Kold Søren S Brink Ole O Larsen Morten Schultz MS Hare Kristoffer Borbjerg KB Palm Henrik H

BMJ open 20201010 10

<h4>Introduction</h4>Undisplaced femoral neck fractures (FNFs) are usually treated by internal fixation (IF) but two randomised controlled trials (RCTs) have demonstrated advantages of treatment with arthroplasty. The complication rate was lowered but there were no clinically improved patient-reported outcome measures (PROM), which could be due to underpowering or choice of selected PROM as the studies do appear to report a better functional outcome. We will conduct an RCT comparing IF with arth ...[more]

PMID: 33040011

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Project description:BackgroundFractures of the femoral shaft are common and have potentially serious consequences in patients with multiple injuries. The appropriate timing of fracture repair is controversial. The purpose of the present study was to assess the effect of timing of internal fixation on mortality in patients with multisystem trauma.MethodsWe performed a retrospective cohort study with use of data from public and private trauma centers throughout the United States that were reported to the National Trauma Data Bank (version 5.0 for 2000 through 2004). The study included 3069 patients with multisystem trauma (Injury Severity Score, > or =15) who underwent internal fixation of a femoral shaft fracture. The time to treatment was defined in categories as the time from admission to internal fixation: t(0) (twelve hours or less), t(1) (more than twelve hours to twenty-four hours), t(2) (more than twenty-four hours to forty-eight hours), t(3) (more than forty-eight hours to 120 hours), and t(4) (more than 120 hours). The relative risk of in-hospital mortality when the four later periods were compared with the earliest one was estimated with inverse probability of treatment-weighted analysis. Subgroups with serious head or neck, chest, abdominal, and additional extremity injury were investigated.ResultsWhen compared with that during the first twelve hours after admission, the estimated mortality risk was significantly lower in three time categories: t(1) (relative risk, 0.45; 95% confidence interval, 0.15 to 0.98; p = 0.03), t(3) (relative risk, 0.58; 95% confidence interval, 0.28 to 0.93; p = 0.03), and t(4) (relative risk, 0.43; 95% confidence interval, 0.10 to 0.94; p = 0.03). Patients with serious abdominal trauma (Abbreviated Injury Score, > or =3) experienced the greatest benefit from a delay of internal fixation beyond twelve hours (relative risk, 0.82 [95% confidence interval, 0.54 to 1.35] for patients with an Abbreviated Injury Score of <3, compared with 0.36 [95% confidence interval, 0.13 to 0.87] for those with an Abbreviated Injury Score of > or =3) (p value for effect modification, 0.09).ConclusionsDelayed repair of femoral shaft fracture beyond twelve hours in patients with multisystem trauma, which may allow time for appropriate resuscitation, reduces mortality by approximately 50%. Patients with serious abdominal injury benefit most from delayed treatment. These results support delaying definitive treatment of long-bone injuries in patients with multisystem trauma as a means of so-called damage-control in order to reduce adverse outcomes.

Project description:IntroductionHip arthroplasty (HA) is commonly performed to treat various hip pathologies. Its volume is expected to rise further due to the increasing age of the population. Complication rates are low; however, periprosthetic femoral fractures (PFF) are a rare, albeit serious, complication with substantial economic impact. While current guidelines propose revision with long-stemmed prostheses for all Vancouver B2 and B3 PFF, some recent research papers suggest that open reduction with internal fixation (ORIF) could lead to an equivalent outcome. Our aim was to summarize the evidence, elucidating under which circumstances ORIF leads to a favorable outcome after B2 and B3 PFF compared with revision surgery.Materials and methodsA systematic literature search was performed to identify studies on patients treated with ORIF and with stem revision after B2 and/or B3 fractures. Extracted information included initial pathology, stem fixation mechanism, bone quality and stem stability at the time of PFF, clinical outcomes, and mortality. Results of individual studies were summarized in a table in lieu of a quantitative data synthesis due to a lack of standardized information.ResultsWe identified 14 original research articles including both patients treated with ORIF and with stem revision after B2 and/or B3 PFF. Five studies included statistical comparisons, all were in favor of ORIF or indeterminate. The common lack of rigorous statistical analyses and significant methodological weaknesses made identification of outcome predictors impossible.ConclusionThe choice of treatment modality for PFF depends on fracture, implant, and bone characteristics. Recent data show that successful outcome can be achieved without revising loose stems. ORIF may be a viable option if bone stock is adequate around uncemented or tapered polished stems with an intact cement mantle and the fracture geometry allows stable anatomic reconstruction. Conceptional considerations support this idea, but more data are needed to identify outcome predictors.

Dataset Information

Is arthroplaSty bEtter than interNal fixation for undiSplaced femoral nEck fracture? A national pragmatic RCT: the SENSE trial.

Publications

Is arthropla<b>S</b>ty b<b>E</b>tter than inter<b>N</b>al fixation for undi<b>S</b>placed femoral n<b>E</b>ck fracture? A national pragmatic RCT: the <b>SENSE</b> trial.

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